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Reconstrução do ligamento cruzado anterior (LCA) com autoenxerto ósseo de tendão ósseo com versus sem órtese interna

16 de setembro de 2026 atualizado por: Columbia University

Reconstrução do LCA com Autoenxerto de Tendão Ósseo (BTB) Com Versus Sem Cinta Interna - Resultados Clínicos e Radiográficos

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.

Visão geral do estudo

Descrição detalhada

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 de estudo

Intervencional

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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

Comparador Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Time to Return to Full Activity or Sports
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: David P Trofa, MD, Associate Professor of Orthopaedic Surgery

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2032

Conclusão do estudo (Estimado)

1 de setembro de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

4 de setembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de setembro de 2022

Primeira postagem (Real)

8 de setembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • AAAU0966

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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