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Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05444465
Recruitment Status : Recruiting
First Posted : July 6, 2022
Last Update Posted : September 8, 2022
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Injuries Device: Isolated Bioinductive Repair Procedure: Completion and Repair Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)
Actual Study Start Date : August 30, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Isolated Bioinductive Repair
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
Device: Isolated Bioinductive Repair
Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant
Other Name: REGENETEN™ Bioinductive Implant

Active Comparator: Completion and Repair
Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.
Procedure: Completion and Repair
Standard surgical repair using the 'Completion and Repair' technique.




Primary Outcome Measures :
  1. Change in Western Ontario Rotator Cuff (WORC) [ Time Frame: 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).


Secondary Outcome Measures :
  1. Western Ontario Rotator Cuff (WORC) [ Time Frame: 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).

  2. Constant-Murley Score [ Time Frame: 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.

  3. Subjective Shoulder Value (SSV) score [ Time Frame: 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).

  4. EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores [ Time Frame: 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.


  5. Change in Western Ontario Rotator Cuff (WORC) [ Time Frame: 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).

  6. Change in Constant-Murley Score [ Time Frame: 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.

  7. Change in Subjective Shoulder Value (SSV) score [ Time Frame: 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).

  8. Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score [ Time Frame: 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.

  9. Percent Achieving MCID for Western Ontario Rotator Cuff (WORC) [ Time Frame: 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).

  10. Percent Achieving MCID for Subjective Shoulder Value (SSV) score [ Time Frame: 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).

  11. Patient Satisfaction [ Time Frame: 6 weeks, 3, 6, 12 and 24 months ]

    Comprise of 2 questions:

    1. Overall, I am satisfied with the outcome of my surgery
    2. I would recommend the procedure to a friend.

    Question rated by the patient with Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.


  12. Pain, Visual analog scale (VAS) Score [ Time Frame: 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.

  13. MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score [ Time Frame: 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.

  14. MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling [ Time Frame: 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%.

  15. MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern [ Time Frame: 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.

  16. MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness [ Time Frame: 12 months ]
    Tendon thickness will be measured in millimeters (mm).

  17. MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification [ Time Frame: 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.

  18. Incidence of Revision Surgery [ Time Frame: 1, 3 and 6 weeks, 3, 6, 12 and 24 months ]
    Number of subjects requiring revision surgery

  19. Time to return to work [ Time Frame: Up to 24 months ]
    Number of weeks taken to return to work following surgery

  20. Time to return to driving [ Time Frame: Up to 24 months ]
    Number of weeks taken to return to driving following surgery

  21. Time to return to sports [ Time Frame: Up to 24 months ]
    Number of weeks taken to return to sport following surgery

  22. Total operative time [ Time Frame: Inter-operative time ]
    Time expressed in minutes

  23. Physical Therapy Utilization [ Time Frame: Up to 24 months ]
    Number visits following index surgery

  24. Cumulative days of opioid use [ Time Frame: 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?'

  25. Duration of shoulder immobilization following index surgery [ Time Frame: 1, 3 and 6 weeks, 3 months ]
    Number of days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 concomitant biceps tenodesis/tenotomy.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05444465


Contacts
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Contact: Judith Horner +44 (0) 1482673251 Judith.Horner@smith-nephew.com
Contact: Alice Kitching +44 (0) 7590001182 Alice.Kitching@smith-nephew.com

Locations
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United States, Georgia
Harbin Clinic Recruiting
Rome, Georgia, United States, 30165
Contact: Terri Brannon         
Principal Investigator: Brandon Bushnell         
United States, Illinois
OrthoIllinois LTD Not yet recruiting
Rockford, Illinois, United States, 61107
Contact: Gauri Tyagi         
Principal Investigator: Scott Trenhaile         
United States, Texas
Texas Orthopedic Specialists Recruiting
Bedford, Texas, United States, 76021
Contact: Amber Morgan         
Principal Investigator: Howard Harris         
Australia, Victoria
OrthoSport Victoria Not yet recruiting
Richmond, Victoria, Australia, 3121
Contact: Haydn Klemm         
Principal Investigator: Soong Chua         
Canada, Alberta
Access Orthopaedics Not yet recruiting
Calgary, Alberta, Canada, T2R 2G5
Contact: Kristie More         
Principal Investigator: Ian Lo         
Canada, Manitoba
Pan Am Clinic Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Sheila Mcrae         
Principal Investigator: Jarret Woodmass         
Canada, Ontario
Research St. Joseph's Not yet recruiting
Hamilton, Ontario, Canada
Contact: Miriam Garrido Clua         
Principal Investigator: Moin Khan         
Italy
IRCCS Istituto Ortopedico Galeazzi, Not yet recruiting
Milano, Italy
Contact: Vincenzo Guarrella         
Principal Investigator: Ettore Taverna         
Fondazione Policlinico Universitario Campus Bio-Medico Not yet recruiting
Roma, Italy
Contact: Giuseppe Longo         
Principal Investigator: Giuseppe Longo         
Spain
Hospital Ramón y Cajal Not yet recruiting
Madrid, Spain, 28034
Contact: Miguel Angel Ruiz Iban         
Principal Investigator: Miguel Angel Ruiz Iban         
United Kingdom
Ashford & St Peter's Hospitals NHS Foundation Trust Not yet recruiting
Chertsey, Surrey, United Kingdom, KT16 0PZ
Contact: Ali Narvani         
Principal Investigator: Ali Narvani         
University Hospital of South Manchester NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M23 9LT
Contact: Lawrie Rogerson-Wynne         
Principal Investigator: Chris Peach         
Northern Care Alliance NHS Foundation Trust Not yet recruiting
Salford, United Kingdom, M6 8HD
Contact: Hannah Howlett         
Principal Investigator: Robin Seagger         
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Laura Mills Smith & Nephew, Inc.
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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT05444465    
Other Study ID Numbers: REGENETEN.2021.04
First Posted: July 6, 2022    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Smith & Nephew, Inc.:
Rotator cuff tear
High grade partial thickness tears
REGENETEN Bioinductive Implant System
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries