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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isolated Bioinductive Repair | Experimental | Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. |
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| Completion and Repair | Active Comparator | Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isolated Bioinductive Repair | Device | Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Western Ontario Rotator Cuff (WORC) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario Rotator Cuff (WORC) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice Kitching | Contact | +44 (0) 7590001182 | alice.kitching@smith-nephew.com | |
| Mary Ozokwere | Contact | +1 469-560-0727 | Mary.Ozokwere@smith-nephew.com |
| Name | Affiliation | Role |
|---|---|---|
| Laura Mills | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Clinic | Recruiting | Rome | Georgia | 30165 | United States |
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| Completion and Repair | Procedure | Standard surgical repair using the 'Completion and Repair' technique. |
|
| Pre-op, 6 weeks, 3, 6, 12 and 24 months |
| Constant-Murley Score | 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 |
| Subjective Shoulder Value (SSV) score | 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 |
| EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores | 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 |
| Change in Western Ontario Rotator Cuff (WORC) | 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 | 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 | 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 | 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) | 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 | 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 | 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 |
| Pain, Visual analog scale (VAS) Score | 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 | 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 | 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 |
| MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern | 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 | Tendon thickness will be measured in millimeters (mm). | 12 months |
| MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification | 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 | Number of subjects requiring revision surgery | 1, 3 and 6 weeks, 3, 6, 12 and 24 months |
| Time to return to work | Number of weeks taken to return to work following surgery | Up to 24 months |
| Time to return to driving | Number of weeks taken to return to driving following surgery | Up to 24 months |
| Time to return to sports | Number of weeks taken to return to sport following surgery | Up to 24 months |
| Total operative time | Time expressed in minutes | Inter-operative time |
| Physical Therapy Utilization | Number visits following index surgery | Up to 24 months |
| Cumulative days of opioid use | 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 | Number of days | 1, 3 and 6 weeks, 3 months |
| OrthoIllinois LTD | Recruiting | Rockford | Illinois | 61107 | United States |
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| Sinai Hospital Baltimore | Withdrawn | Baltimore | Maryland | 21215 | United States |
| Cleveland Clinic - Sports Health | Withdrawn | Garfield Heights | Ohio | 44125 | United States |
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Texas Orthopedic Specialists | Recruiting | Bedford | Texas | 76021 | United States |
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| Houston Methodist The Woodlands | Withdrawn | The Woodlands | Texas | 77385 | United States |
| Memorial Medical Center | Withdrawn | Ashland | Wisconsin | 54806 | United States |
| OrthoSport Victoria | Recruiting | Richmond | Victoria | 3121 | Australia |
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| Access Orthopaedics | Recruiting | Calgary | Alberta | T2R 2G5 | Canada |
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| Pan Am Clinic | Recruiting | Winnipeg | Manitoba | Canada |
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| Research St. Joseph's | Recruiting | Hamilton | Ontario | Canada |
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| IRCCS Istituto Ortopedico Galeazzi, | Recruiting | Milan | Italy |
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| Fondazione Policlinico Universitario Campus Bio-Medico | Recruiting | Roma | Italy |
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| Hospital Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
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| Hospital Fundación Jiménez Díaz | Recruiting | Madrid | 28040 | Spain |
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| Ashford & St Peter's Hospitals NHS Foundation Trust | Recruiting | Chertsey | Surrey | KT16 0PZ | United Kingdom |
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| Sulis Hospital | Recruiting | Bath | United Kingdom |
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| North Bristol NHS Trust | Recruiting | Bristol | United Kingdom |
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| Northern Care Alliance NHS Foundation Trust | Withdrawn | Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D014945 | Wound Healing |
| ID | Term |
|---|---|
| D012038 | Regeneration |
| D001686 | Biological Phenomena |
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