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Ricostruzione del legamento crociato anteriore (LCA) con autoinnesto osseo del tendine osseo con versus senza rinforzo interno

16 settembre 2026 aggiornato da: Columbia University

Ricostruzione del LCA con innesto osseo tendineo (BTB) autotrapianto con rispetto a senza tutore interno - Esiti clinici e radiografici

There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.

Panoramica dello studio

Descrizione dettagliata

Despite the wide variety of surgical approaches and grafts that can be used in an ACL reconstruction, graft failure and recurrent knee instability are nevertheless ubiquitous issues that have facilitated interest in ways to strengthen the graft at the time of surgery. While both animal and biomechanical models have strongly suggested improved graft strength and patient outcomes by utilizing suture tape augmentation in ACL reconstructions, there is scant clinical literature available to assess these extrapolations. A retrospective cohort study of 60 patients undergoing ACL reconstruction with a hamstring autograft or allograft (30 suture tape vs 30 no suture tape; mean age: 30), found shorter time to return to activity (9.2 months suture tape group vs 12.9 months no suture tape group; p=0.002), lower Western Ontario and McMaster University Osteoarthritis Indices (WOMAC) (2.2 suture tape group vs 6.2 no suture tape group; p=0.024), higher international knee documentation committee (IKDC) scores (87.6 suture tape group vs 73.2 no suture tape group; p=0.006), lower average pain on the national pain rating scale (NPRS) (0.6 suture tape group vs 1.66 no suture tape group; p=0.021) and no significant difference in range of motion in degrees (129 suture tape group vs 127 no suture tape group; p=0.46), knee injury and osteoarthritis outcome score (KOOS) (92.2 suture tape group vs 87.1 no suture tape group; p=0.68), or complications (13% suture tape vs 10% no suture tape; p>0.05) at 2 years follow up. A retrospective cohort study of 108 patients undergoing ACL reconstruction with a hamstring autograft with and without suture tape reinforcement (36 suture tape vs 72 no suture tape; mean age: 25), found a significantly higher Tegner activity score (7.1 suture tape group vs 6.4 no suture tape group; p=0.026) but otherwise no significant difference in time to preinjury activity level (11.9 mos suture tape group vs 11.6 no suture tape group; p=0.59), range of motion (degrees) (136 suture tape group vs 137 no suture tape group; p=0.44) , Lysholm knee score (95.6 suture tape group vs 94 no suture tape group; p=0.165), IKDC score (94.4 suture tape group vs 93.8 no suture tape group; p=0.44), or complications (6% suture tape group vs 5% no suture tape group; p>0.05) at 2 years follow up. A prospective cohort study of 50 ACL reconstructions with hamstring autograft with and without suture tape reinforcement (25 suture tape group vs 25 no suture tape group; mean age: 30), found a significant improvement in greater than 2 grades of Lachman testing from preoperative assessment compared to 6 months follow-up (68% suture tape group vs 32% no suture tape group; p=0.039) but no difference in Lysholm knee score at 6 months (87.0 suture tape group vs 87.0 no suture tape group; p=0.756). Moreover, none of the already-limited clinical data investigates the use of internal braces with bone-tendon-bone grafts, which are a popular choice for young adults and athletes. Furthermore, there are no current level 1 data on this subject. Therefore, this study aims to compare the time to return to pre- injury activity level, incidence of recurrent knee instability, and patient reported outcomes of patients treated with ACL reconstruction using bone-tendon-bone autograft with and without (control group) internal brace stabilization.

Tipo di studio

Interventistico

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

12 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • patients 12 and older
  • patients seen by the Columbia University Sports Medicine Service
  • patients diagnosed with a first time ACL injury by clinical exam and MRI

Exclusion Criteria:

  • previous knee surgery
  • concurrent knee fracture or ligamentous injury on ipsilateral knee
  • neuromuscular disorder involving lower limb
  • inability/ unwillingness to adhere to protocol
  • anesthesia contraindications
  • lost to follow up

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ACL reconstruction with internal brace augmentation (suture tape)

This group will receive a standard ACL reconstruction using a BTB autograft with suture tape augmentation on the graft to strengthen it during the surgical procedure.

The ACL will be reconstructed using a participant's own patella tendon (BTB autograft), and the graft will be fortified by suture tape during the surgery in order to strengthen it.

Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy

Comparatore attivo: ACL reconstruction without internal brace augmentation

This group will only receive a standard ACL reconstruction using a BTB autograft. No suture tape will be added to the graft during the surgical procedure.

Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy

The ACL will be reconstructed using a participant's own patella tendon (BTB autograft). The graft will not be fortified by suture tape in this group. It will be used as is without any modification.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Return to Full Activity or Sports
Lasso di tempo: Measured once per participant, depending on the time required to return to full activity (up to 10 years)

Time from treatment initiation to full return to pre-injury activity levels in each group, expressed in weeks

Measured once per participant, depending on the time required to return to full activity (up to 10 years)
Percentage of Participants with Recurrent Knee Instability
Lasso di tempo: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years

Percentage of participants that experience recurrent instability after treatment starts at each time point

2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeks
Lasso di tempo: Baseline and 2 weeks

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 2 weeks
Change in PROMIS PF CAT at 6 weeks
Lasso di tempo: Baseline and 6 weeks

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 6 weeks
Change in PROMIS PF CAT at 3 months
Lasso di tempo: Baseline and 3 months

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 3 months
Change in PROMIS PF CAT at 6 months
Lasso di tempo: Baseline and 6 months

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 6 months
Change in PROMIS PF CAT at 1 year
Lasso di tempo: Baseline and 1 year

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 1 year
Change in PROMIS PF CAT at 2 years
Lasso di tempo: Baseline and 2 years

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 2 years
Change in PROMIS PF CAT at 5 years
Lasso di tempo: Baseline and 5 years

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 5 years
Change in PROMIS PF CAT at 10 years
Lasso di tempo: Baseline and 10 years

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 10 years
Change in PROMIS Pain Interference (PI) CAT at 2 weeks
Lasso di tempo: Baseline and 2 weeks

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 2 weeks
Change in PROMIS PI CAT at 6 weeks
Lasso di tempo: Baseline and 6 weeks

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 6 weeks
Change in PROMIS PI CAT at 3 months
Lasso di tempo: Baseline and 3 months

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 3 months
Change in PROMIS PI CAT at 6 months
Lasso di tempo: Baseline and 6 months

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 6 months
Change in PROMIS PI CAT at 1 year
Lasso di tempo: Baseline and 1 year

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 1 year
Change in PROMIS PI CAT at 2 years
Lasso di tempo: Baseline and 2 years

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 2 years
Change in PROMIS PI CAT at 5 years
Lasso di tempo: Baseline and 5 years

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 5 years
Change in PROMIS PI CAT at 10 years
Lasso di tempo: Baseline and 10 years

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 10 years
Change in PROMIS Depression CAT at 2 weeks
Lasso di tempo: Baseline and 2 weeks

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 2 weeks
Change in PROMIS Depression CAT at 6 weeks
Lasso di tempo: Baseline and 6 weeks

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 6 weeks
Change in PROMIS Depression CAT at 3 months
Lasso di tempo: Baseline and 3 months

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 3 months
Change in PROMIS Depression CAT at 6 months
Lasso di tempo: Baseline and 6 months

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 6 months
Change in PROMIS Depression CAT at 1 year
Lasso di tempo: Baseline and 1 year

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 1 year
Change in PROMIS Depression CAT at 2 years
Lasso di tempo: Baseline and 2 years

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 2 years
Change in PROMIS Depression CAT at 5 years
Lasso di tempo: Baseline and 5 years

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 5 years
Change in PROMIS Depression CAT at 10 years
Lasso di tempo: Baseline and 10 years

A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

Baseline and 10 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks
Lasso di tempo: Baseline and 2 weeks

The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.

Baseline and 2 weeks
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 weeks
Lasso di tempo: Baseline and 6 weeks

The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.

Baseline and 6 weeks
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 months
Lasso di tempo: Baseline and 3 months

The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.

Baseline and 3 months
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 months
Lasso di tempo: Baseline and 6 months

The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.

Baseline and 6 months
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 year
Lasso di tempo: Baseline and 1 year

The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.

Baseline and 1 year
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 years
Lasso di tempo: Baseline and 2 years

The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.

Baseline and 2 years
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 5 years
Lasso di tempo: Baseline and 5 years

The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.

Baseline and 5 years
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 10 years
Lasso di tempo: Baseline and 10 years

The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.

Baseline and 10 years
Change in International Knee Documentation Committee (IKDC) Score at 2 weeks
Lasso di tempo: Baseline and 2 weeks

The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity.

Baseline and 2 weeks
Change in International Knee Documentation Committee (IKDC) Score at 6 weeks
Lasso di tempo: Baseline and 6 weeks

The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity.

Baseline and 6 weeks
Change in International Knee Documentation Committee (IKDC) Score at 3 months
Lasso di tempo: Baseline and 3 months

The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity.

Baseline and 3 months
Change in International Knee Documentation Committee (IKDC) Score at 6 months
Lasso di tempo: Baseline and 6 months

The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity.

Baseline and 6 months
Change in International Knee Documentation Committee (IKDC) Score at 1 year
Lasso di tempo: Baseline and 1 year

The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity.

Baseline and 1 year
Change in International Knee Documentation Committee (IKDC) Score at 2 years
Lasso di tempo: Baseline and 2 years

The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity.

Baseline and 2 years
Change in International Knee Documentation Committee (IKDC) Score at 5 years
Lasso di tempo: Baseline and 5 years

The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity.

Baseline and 5 years
Change in International Knee Documentation Committee (IKDC) Score at 10 years
Lasso di tempo: Baseline and 10 years

The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity.

Baseline and 10 years
Change in numeric pain rating scale (NPRS) Score at 2 weeks
Lasso di tempo: Baseline and 2 weeks

The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain)

Baseline and 2 weeks
Change in numeric pain rating scale (NPRS) Score at 6 weeks
Lasso di tempo: Baseline and 6 weeks

The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain)

Baseline and 6 weeks
Change in numeric pain rating scale (NPRS) Score at 3 months
Lasso di tempo: Baseline and 3 months

The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain)

Baseline and 3 months
Change in numeric pain rating scale (NPRS) Score at 6 months
Lasso di tempo: Baseline and 6 months

The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain)

Baseline and 6 months
Change in numeric pain rating scale (NPRS) Score at 1 year
Lasso di tempo: Baseline and 1 year

The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain)

Baseline and 1 year
Change in numeric pain rating scale (NPRS) Score at 2 years
Lasso di tempo: Baseline and 2 years

The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain)

Baseline and 2 years
Change in numeric pain rating scale (NPRS) Score at 5 years
Lasso di tempo: Baseline and 5 years

The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain)

Baseline and 5 years
Change in numeric pain rating scale (NPRS) Score at 10 years
Lasso di tempo: Baseline and 10 years

The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain)

Baseline and 10 years
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 weeks
Lasso di tempo: Baseline and 2 weeks

The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity )

Baseline and 2 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
Lasso di tempo: Baseline and 6 weeks

The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity )

Baseline and 6 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
Lasso di tempo: Baseline and 3 months

The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity )

Baseline and 3 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
Lasso di tempo: Baseline and 6 months

The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity )

Baseline and 6 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 year
Lasso di tempo: Baseline and 1 year

The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity )

Baseline and 1 year
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 years
Lasso di tempo: Baseline and 2 years

The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity )

Baseline and 2 years
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 5 years
Lasso di tempo: Baseline and 5 years

The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity )

Baseline and 5 years
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 years
Lasso di tempo: Baseline and 10 years

The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity )

Baseline and 10 years
Change in Tegner activity scale (TAS) Score at 2 weeks
Lasso di tempo: Baseline and 2 weeks

TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete.

Baseline and 2 weeks
Change in Tegner activity scale (TAS) Score at 6 weeks
Lasso di tempo: Baseline and 6 weeks

TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete.

Baseline and 6 weeks
Change in Tegner activity scale (TAS) Score at 3 months
Lasso di tempo: Baseline and 3 months

TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete.

Baseline and 3 months
Change in Tegner activity scale (TAS) Score at 6 months
Lasso di tempo: Baseline and 6 months

TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete.

Baseline and 6 months
Change in Tegner activity scale (TAS) Score at 1 year
Lasso di tempo: Baseline and 1 year

TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete.

Baseline and 1 year
Change in Tegner activity scale (TAS) Score at 2 years
Lasso di tempo: Baseline and 2 years

TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete.

Baseline and 2 years
Change in Tegner activity scale (TAS) Score at 5 years
Lasso di tempo: Baseline and 5 years

TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete.

Baseline and 5 years
Change in Tegner activity scale (TAS) Score at 10 years
Lasso di tempo: Baseline and 10 years

TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete.

Baseline and 10 years
Change in Lysholm Score at 2 weeks
Lasso di tempo: Baseline and 2 weeks

Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms.

Baseline and 2 weeks
Change in Lysholm Score at 6 weeks
Lasso di tempo: Baseline and 6 weeks

Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms.

Baseline and 6 weeks
Change in Lysholm Score at 3 months
Lasso di tempo: Baseline and 3 months

Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms.

Baseline and 3 months
Change in Lysholm Score at 6 months
Lasso di tempo: Baseline and 6 months

Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms.

Baseline and 6 months
Change in Lysholm Score at 1 year
Lasso di tempo: Baseline and 1 year

Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms.

Baseline and 1 year
Change in Lysholm Score at 2 years
Lasso di tempo: Baseline and 2 years

Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms.

Baseline and 2 years
Change in Lysholm Score at 5 years
Lasso di tempo: Baseline and 5 years

Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms.

Baseline and 5 years
Change in Lysholm Score at 10 years
Lasso di tempo: Baseline and 10 years

Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms.

Baseline and 10 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: David P Trofa, MD, Associate Professor of Orthopaedic Surgery

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2032

Completamento dello studio (Stimato)

1 settembre 2032

Date di iscrizione allo studio

Primo inviato

4 settembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

4 settembre 2022

Primo Inserito (Effettivo)

8 settembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • AAAU0966

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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