Brug af det REGENETEN™ bioinduktive implantatsystem i høj grad af delvis tykkelse tårer (IMPACT)
Evaluering af sikkerhed og effektivitet af et resorberbart kollagenimplantat ved behandling af højgradige partielle tykkelser; Et prospektivt, multicenter, randomiseret kontrolforsøg (IMPACT-undersøgelse)
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
The primary objective of this study is to evaluate the functional recovery of patients with high grade (>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Mary Ozokwere
- Telefonnummer: +1 469-560-0727
- E-mail: Mary.Ozokwere@smith-nephew.com
Undersøgelse Kontakt Backup
- Navn: Judith Horner
- Telefonnummer: +44 (0) 7834614336
- E-mail: judith.horner@smith-nephew.com
Studiesteder
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Victoria
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Richmond, Victoria, Australien, 3121
- Rekruttering
- OrthoSport Victoria
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Ledende efterforsker:
- Soong Chua
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Kontakt:
- Haydn Klemm
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Alberta
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Calgary, Alberta, Canada, T2R 2G5
- Rekruttering
- Access Orthopaedics
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Kontakt:
- Kristie More
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Ledende efterforsker:
- Ian Lo
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Manitoba
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Winnipeg, Manitoba, Canada
- Aktiv, ikke rekrutterende
- Pan Am Clinic
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Ontario
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Hamilton, Ontario, Canada
- Rekruttering
- Research St. Joseph's
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Ledende efterforsker:
- Moin Khan
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Kontakt:
- Danielle Dagher
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Bath, Det Forenede Kongerige
- Rekruttering
- Sulis Hospital
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Ledende efterforsker:
- Andrew Chambler
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Bristol, Det Forenede Kongerige
- Rekruttering
- North Bristol NHS Trust
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Kontakt:
- Steven Barnfield
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Ledende efterforsker:
- Iain Packham
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Salford, Det Forenede Kongerige, M6 8HD
- Trukket tilbage
- Northern Care Alliance NHS Foundation Trust
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Surrey
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Chertsey, Surrey, Det Forenede Kongerige, KT16 0PZ
- Rekruttering
- Ashford & St Peter's Hospitals NHS Foundation Trust
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Ledende efterforsker:
- Ali Narvani
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Kontakt:
- Timnit Tekie
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Georgia
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Rome, Georgia, Forenede Stater, 30165
- Rekruttering
- Harbin Clinic
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Ledende efterforsker:
- Brandon Bushnell
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Kontakt:
- Terri Brannon
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Illinois
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Rockford, Illinois, Forenede Stater, 61107
- Rekruttering
- OrthoIllinois LTD
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Ledende efterforsker:
- Scott Trenhaile
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Kontakt:
- Catherine Ayala
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Maryland
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Baltimore, Maryland, Forenede Stater, 21215
- Trukket tilbage
- Sinai Hospital Baltimore
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Ohio
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Garfield Heights, Ohio, Forenede Stater, 44125
- Trukket tilbage
- Cleveland Clinic - Sports Health
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Rekruttering
- University of Pittsburgh
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Ledende efterforsker:
- Albert Lin
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Kontakt:
- Alec Howard
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Texas
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Bedford, Texas, Forenede Stater, 76021
- Aktiv, ikke rekrutterende
- Texas Orthopedic Specialists
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The Woodlands, Texas, Forenede Stater, 77385
- Trukket tilbage
- Houston Methodist The Woodlands
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Wisconsin
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Ashland, Wisconsin, Forenede Stater, 54806
- Trukket tilbage
- Memorial Medical Center
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Milan, Italien
- Rekruttering
- IRCCS Istituto Ortopedico Galeazzi,
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Kontakt:
- Vincenzo Guarrella
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Ledende efterforsker:
- Ettore Taverna
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Roma, Italien
- Rekruttering
- Fondazione Policlinico Universitario Campus Bio-Medico
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Kontakt:
- Giuseppe Longo
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Ledende efterforsker:
- Giuseppe Longo
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Madrid, Spanien, 28034
- Rekruttering
- Hospital Ramón y Cajal
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Kontakt:
- Miguel Angel Ruiz Iban
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Ledende efterforsker:
- Miguel Angel Ruiz Iban
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Madrid, Spanien, 28040
- Rekruttering
- Hospital Fundación Jiménez Díaz
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Kontakt:
- Cristina Delgado del Cano
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Ledende efterforsker:
- Emilio Calvo
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- The subject must provide written informed consent.
- Subject is > eighteen (18) years of age (no upper limit).
- Subject has an isolated high-grade (>50% or >6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
- Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
- Subject willing and able to make all required study visits.
- Subject able to follow instructions and deemed capable of completing all study questionnaires.
Exclusion Criteria:
- Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
- Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
- Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
- Subjects with current or prior infection of the ipsilateral shoulder.
- Subjects with known hypersensitivity to bovine-derived materials.
- Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
- Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
- Subjects with a planned surgery on the contra-lateral shoulder within the study period.
- Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
- Subjects with a full thickness rotator cuff tear.
- Subjects with a subscapularis tear requiring repair.
- Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
- Subjects requiring a concomitant os acromiale fixation procedure.
- Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
- Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head.
- Subjects with neurologic conditions effecting either upper extremity.
- Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
- Subjects who are pregnant or breast feeding.
- Subjects who are currently involved in any injury litigation relating to the index shoulder.
- Subjects with current workers compensation claim.
- Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
- Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
- Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse.
- Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
- Subjects who have participated previously in this clinical trial and who have healed or been withdrawn
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Isolated Bioinductive Repair
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. |
Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant
Andre navne:
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Aktiv komparator: Completion and Repair
Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'. |
Standard surgical repair using the 'Completion and Repair' technique. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Western Ontario Rotator Cuff (WORC)
Tidsramme: Change from baseline to 3 months post-intervention
|
The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level). |
Change from baseline to 3 months post-intervention
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Western Ontario Rotator Cuff (WORC)
Tidsramme: Pre-op, 6 weeks, 3, 6, 12 and 24 months
|
The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level). |
Pre-op, 6 weeks, 3, 6, 12 and 24 months
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Constant-Murley Score
Tidsramme: Pre-Op, 3, 6, 12 and 24 months
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The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function. |
Pre-Op, 3, 6, 12 and 24 months
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Subjective Shoulder Value (SSV) score
Tidsramme: Pre-Op, 6 weeks, 3, 12 and 24 months
|
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal). |
Pre-Op, 6 weeks, 3, 12 and 24 months
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EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores
Tidsramme: Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months
|
To assess the subject's health state. The EQ-5D-5L is composed of the EQ- 5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ- 5D-5L profile. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale ranging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome. |
Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months
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Change in Western Ontario Rotator Cuff (WORC)
Tidsramme: Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months
|
The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level). |
Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months
|
|
Change in Constant-Murley Score
Tidsramme: Change from Pre-Op to 6 weeks, 3, 12 and 24 months
|
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function. |
Change from Pre-Op to 6 weeks, 3, 12 and 24 months
|
|
Change in Subjective Shoulder Value (SSV) score
Tidsramme: Change from Pre-Op to 6 weeks, 3, 12 and 24 months
|
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal). |
Change from Pre-Op to 6 weeks, 3, 12 and 24 months
|
|
Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score
Tidsramme: Pre-Op, 3, 6, 12 and 24 months
|
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function. |
Pre-Op, 3, 6, 12 and 24 months
|
|
Percent Achieving MCID for Western Ontario Rotator Cuff (WORC)
Tidsramme: Pre-op, 6 weeks, 3, 6, 12 and 24 months
|
The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level). |
Pre-op, 6 weeks, 3, 6, 12 and 24 months
|
|
Percent Achieving MCID for Subjective Shoulder Value (SSV) score
Tidsramme: Pre-Op, 6 weeks, 3, 12 and 24 months
|
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal). |
Pre-Op, 6 weeks, 3, 12 and 24 months
|
|
Patient Satisfaction
Tidsramme: 6 weeks, 3, 6, 12 and 24 months
|
Comprise of 2 questions:
Question rated by the patient with Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree. |
6 weeks, 3, 6, 12 and 24 months
|
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Pain, Visual analog scale (VAS) Score
Tidsramme: Pre-Op, 3 and 6 weeks, 3, 12 and 24 months
|
Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable. |
Pre-Op, 3 and 6 weeks, 3, 12 and 24 months
|
|
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score
Tidsramme: 12 months
|
The Sugaya score is classified into 5 categories: Type I to Type V. Type I indicates sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear. |
12 months
|
|
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling
Tidsramme: 12 months
|
Percent tissue infil is graded at site of original tear and classified as 0% to < 25%, 25% to < 50%, 50% to < 75%, 75% to < 100% and 100%. |
12 months
|
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MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern
Tidsramme: 12 months
|
The Signal Intensity Pattern will be graded into 3 categories. Type I: Heterogeneous high signal intensity with fluid-like bright foci, Type II: Heterogeneous high signal intensity without fluid-like bright foci, Type III: Heterogeneous or homogeneous low signal intensity. |
12 months
|
|
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness
Tidsramme: 12 months
|
Tendon thickness will be measured in millimeters (mm). |
12 months
|
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MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification
Tidsramme: 12 months
|
The Goutallier classification will be used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. |
12 months
|
|
Incidence of Revision Surgery
Tidsramme: 1, 3 and 6 weeks, 3, 6, 12 and 24 months
|
Number of subjects requiring revision surgery |
1, 3 and 6 weeks, 3, 6, 12 and 24 months
|
|
Time to return to work
Tidsramme: Up to 24 months
|
Number of weeks taken to return to work following surgery |
Up to 24 months
|
|
Time to return to driving
Tidsramme: Up to 24 months
|
Number of weeks taken to return to driving following surgery |
Up to 24 months
|
|
Time to return to sports
Tidsramme: Up to 24 months
|
Number of weeks taken to return to sport following surgery |
Up to 24 months
|
|
Total operative time
Tidsramme: Inter-operative time
|
Time expressed in minutes |
Inter-operative time
|
|
Physical Therapy Utilization
Tidsramme: Up to 24 months
|
Number visits following index surgery |
Up to 24 months
|
|
Cumulative days of opioid use
Tidsramme: Day 1-14
|
Self-reported opioid use diary completed by the patient on a daily basis, from day 0-14, documenting opioid use. Consumption daily (YES/NO) x14 days, 'Have you taken any opioid medication today for shoulder pain?' |
Day 1-14
|
|
Duration of shoulder immobilization following index surgery
Tidsramme: 1, 3 and 6 weeks, 3 months
|
Number of days |
1, 3 and 6 weeks, 3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studiestol: Laura Mills, Smith & Nephew, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- REGENETEN.2021.04
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