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NCT Number: NCT04861714

Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)

The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis healing and improve clinical outcomes.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Arthroplasty, Replacement, Shoulder

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Sports Medicine Center

Columbus, Ohio, 43221, United States

About this study

Subscapularis management is an area of controversy in the literature for total shoulder arthroplasty (TSA). Regeneten has been suggested as a bioinductive implant to aid in rotator cuff healing. We hypothesize that applying this technology could aid in obtaining higher rates of subscapularis healing for TSA when utilizing SP or ST, which in turn could lead to improved outcomes.The 50 randomized subjects will be randomized at a 1:1 ratio into the standard subscapularis repair group or the standard repair with Regeneten augmentation group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent surgical procedure, the blinded assignment will be revealed to the subject. Subjects will be assessed pre-operatively and return post-operatively at Week 2, Weeks 6, Month 3, Month 6, and Year 1. The primary outcome will evaluate subscapularis repair integrity and healing at one year post-op.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients healthy enough to undergo primary anatomic TSA
  • Being treated with subscapularis tenotomy or subscapularis peel.
  • Age 50 or above
  • Intact rotator cuff including subscapularis as determined by preoperative examination and imaging (typically preoperative CT, MRI if indicated or available).

Exclusion criteria

  • Revision arthroplasty
  • Reverse arthroplasty
  • Requiring a lesser tuberosity osteotomy
  • Intraoperative identification of rotator cuff tear requiring repair
  • Object to using cow derived material
  • Prior index shoulder surgery requiring treatment to the subscapularis

Treatment and study plan

Regeneten

Device

Augmentation of standard subscapularis repair with regeneten patch

Standard repair

Procedure

Standard subscapularis repair

Primary outcomes

  1. Subscapularis repair integrity assessed by lift-off test using dynamometry.

    Time frame: 12 months post-op

    Pounds (lbs) of force that the subject can produce during the lift off test will be recorded.

Secondary outcomes

  1. Forward elevation active range of motion as assessed by treating physician

    Time frame: 6 weeks

    The amount of forward elevation range of motion will be reported in degrees from 0-180.

  2. Forward elevation active range of motion as assessed by treating physician

    Time frame: 3 months

    The amount of forward elevation range of motion will be reported in degrees from 0-180.

  3. Forward elevation active range of motion as assessed by treating physician

    Time frame: 6 months

    The amount of forward elevation range of motion will be reported in degrees from 0-180.

  4. Forward elevation active range of motion as assessed by treating physician

    Time frame: 12 months

    The amount of forward elevation range of motion will be reported in degrees from 0-180.

  5. Abduction active range of motion as assessed by treating physician

    Time frame: 6 weeks

    The amount of abduction range of motion will be reported in degrees from 0-180.

  6. Abduction active range of motion as assessed by treating physician

    Time frame: 3 months

    The amount of abduction range of motion will be reported in degrees from 0-180.

  7. Abduction active range of motion as assessed by treating physician

    Time frame: 6 months

    The amount of abduction range of motion will be reported in degrees from 0-180.

  8. Abduction active range of motion as assessed by treating physician

    Time frame: 12 months

    The amount of abduction range of motion will be reported in degrees from 0-180.

  9. External rotation active range of motion as assessed by treating physician

    Time frame: 6 weeks

    The amount of external rotation range of motion will be reported in degrees from 0-180.

  10. External rotation active range of motion as assessed by treating physician

    Time frame: 3 months

    The amount of external rotation range of motion will be reported in degrees from 0-180.

  11. External rotation active range of motion as assessed by treating physician

    Time frame: 6 months

    The amount of external rotation range of motion will be reported in degrees from 0-180.

  12. External rotation active range of motion as assessed by treating physician

    Time frame: 12 months

    The amount of external rotation range of motion will be reported in degrees from 0-180.

  13. Internal rotation active range of motion as assessed by treating physician

    Time frame: 6 weeks

    The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.

  14. Internal rotation active range of motion as assessed by treating physician

    Time frame: 3 months

    The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.

  15. Internal rotation active range of motion as assessed by treating physician

    Time frame: 6 months

    The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.

  16. Internal rotation active range of motion as assessed by treating physician

    Time frame: 12 months

    The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.

  17. Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)

    Time frame: 6 weeks

    The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

  18. Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)

    Time frame: 3 months

    The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

  19. Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)

    Time frame: 6 months

    The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

  20. Patient reported clinical outcome scores- American Shoulder and Elbow Surgeon Evaluation (ASES)

    Time frame: 12 months

    The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

  21. Patient reported clinical outcome scores- Visual Analog Scale (VAS)

    Time frame: 6 weeks

    The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.

  22. Patient reported clinical outcome scores- Visual Analog Scale (VAS)

    Time frame: 3 months

    The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.

  23. Patient reported clinical outcome scores- Visual Analog Scale (VAS)

    Time frame: 6 months

    The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.

  24. Patient reported clinical outcome scores- Visual Analog Scale (VAS)

    Time frame: 12 months

    The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.

  25. Patient reported clinical outcome scores- Simple shoulder test (SST)

    Time frame: 6 weeks

    The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.

  26. Patient reported clinical outcome scores- Simple shoulder test (SST)

    Time frame: 3 months

    The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.

  27. Patient reported clinical outcome scores- Simple shoulder test (SST)

    Time frame: 6 months

    The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.

  28. Patient reported clinical outcome scores- Simple shoulder test (SST)

    Time frame: 12 months

    The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.

  29. Patient reported clinical outcome scores- Simple shoulder value (SST)

    Time frame: 6 weeks

    The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.

  30. Patient reported clinical outcome scores- Simple shoulder value (SST)

    Time frame: 3 months

    The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.

  31. Patient reported clinical outcome scores- Simple shoulder value (SST)

    Time frame: 6 months

    The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.

  32. Patient reported clinical outcome scores- Simple shoulder value (SST)

    Time frame: 12 months

    The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Smith & Nephew, Inc.

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Apr 27, 2021
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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