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Trial record 65 of 582 for:    Recruiting, Not yet recruiting, Available Studies | Superior

Superior Capsule Reconstruction vs Partial Repair of Massive Rotator Cuff Tears (SCR)

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ClinicalTrials.gov Identifier: NCT03617562
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:

Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, it's effectiveness, cost, and safety profile has not been established.

The long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical trial.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Procedure: Superior Capsule Reconstruction Procedure: Partial Repair Not Applicable

Detailed Description:

The current study seeks to improve the management of patients suffering from massive irreparable rotator cuff tears. Despite several available surgical options, no level 1 evidence or randomized clinical trials have been performed in this patient population to date. Arthroscopic partial rotator cuff repair (PRCR) is arguably the gold-standard surgical option with the longest record of use. The new technique of superior capsular reconstruction (SCR) has also emerged with early biomechanical and case series showing promising results. SCR has quickly made its way into clinical practice in North America. Despite this, the effectiveness, cost, and safety profile has not been established for this procedure. As such, patients with massive irreparable rotator cuff tears are in need of high level evidence to support surgical decision making, particular with regards to the proliferation of SCR surgery.

This pilot study is a randomized, controlled, double-blinded trial comparing superior capsular reconstruction using dermal allograft with arthroscopic partial repair in patients with massive irreparable rotator cuff tears. In this study, "double-blind" includes study patients and outcome assessors. Randomization will occur intra-operatively once a tear is determined to be irreparable.

This trial will be conducted at 7 sites and involve 7 surgeons. Surgeons must meet eligibility requirements to participate (shoulder or sports fellowship-trained, minimum of 3 SCR procedures, and 25 arthroscopic rotator cuff repair procedures in the past year). A member of the local research team will pre-screen consults of eligible patients. Full eligibility will be determined during the primary appointment with an orthopaedic surgeon. Baseline data will be recorded following informed consent. Postoperative outcomes will be measured during regularly scheduled clinic visits (3 months, 6 months, and 1-year post-surgery).

Prior to surgery, patients will have informed consent for both procedures, with randomization to be performed intraoperatively. Based on initial arthroscopic assessment of the shoulder, patients that have a confirmed irreparable tear will be randomized into one of two groups: arthroscopic partial repair or superior capsular reconstruction. Surgical techniques will be standardized. Allocation will be concealed using a centralized 24-hour computerized randomization system that will allow Internet-based allocation. A random number generator will be used to create a 1:1 allocation scheme for randomization of the patient into one of the two treatment groups. The post-operative therapy regimen will be the same for each group.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arthroscopic Partial Repair vs. Superior Capsular Reconstruction for Massive Irreparable Rotator Cuff Tears: A Pilot Randomized Control Trial
Actual Study Start Date : July 18, 2018
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Superior Capsule Reconstruction
Patients will be treated with the new technique of superior capsule reconstruction with dermal allograft.
Procedure: Superior Capsule Reconstruction
Residual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head.

Active Comparator: Partial Repair
Patients will have a partial repair with residual defect as an established standard procedure.
Procedure: Partial Repair
Rotator cuff is repaired with residual defect left remaining.




Primary Outcome Measures :
  1. The American Shoulder and Elbow Surgeons Shoulder Score (ASES) [ Time Frame: 1 year post operative ]

    Functional Outcome Score

    Sub scales: Pain (10 cm VAS); function/disability (10 items, each rated on 4‐point Likert scale for level of difficulty)

    Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability)



Secondary Outcome Measures :
  1. Complication rate [ Time Frame: 1 year post operative ]
    Incidence of minor and major complications related to each procedure.

  2. Recruitment rate [ Time Frame: 1 year post operative ]
    Assessment of number of eligible patients identified and number enrolled and randomized.

  3. Constant-Murley Score [ Time Frame: 1 year post operative ]

    Functional outcome score

    Sub scales: Pain item (4 Likert levels), Activities of Daily Living (Likert scales), Mobility (2 points for every 30 degrees of elevation), Strength (1 point per 0.5 kg)

    Score Range: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). Total score: 0-100. The higher the score, the higher the quality of the function.


  4. Western Ontario Rotator Cuff Index [ Time Frame: 1 year post operative ]

    Functional outcome score

    Consists of 21 visual analog scale (VAS) items organised in 5 subscales: physical symptoms, sports/recreation, work, lifestyle, and emotions.

    Each item in WORC has a possible score from 0-100 (100mm VAS). Scores can be computed for individual subscales and summated for a total score, which can range from 0-2100, with a higher score representing lower quality of life.


  5. Pain: Numeric Rating Scale [ Time Frame: 1 year post operative ]
    Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.

  6. Range of Motion [ Time Frame: 1 year post operative ]
    Measured by handheld goniometer

  7. EQ-5D [ Time Frame: 1 year post operative ]

    Health Related Quality of Life

    The EQ-5D questionnaire is made up for two components; health state description and evaluation.

    In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3.

    Visual analogue scale: 20 cm vertical scale with end points of 0 and 100. 0 corresponds to " the worst health you can imagine", and 100 corresponds to "the best health you can imagine".


  8. Xray: Acromio-Humeral Interval [ Time Frame: 1 year post operative ]
    Measured distance from inferior acromion to superior humeral head at the closest distance. Distance in millimetres.

  9. Xray: Degenerative Change [ Time Frame: 1 year post operative ]

    Measured by Samilson-Prieto Grade:

    Mild Arthritis (Grade 1): inferior humeral and/or glenoid exostosis < 3mm in height

    Moderate Arthritis (Grade 2): inferior humeral and/or glenoid exostosis measuring 3mm to 7mm slight gleno-humeral irregularity

    Severe Arthritis (Grade 3): inferior humeral and/or glenoid exostosis measuring > 7mm gleno-humeral joint narrowing and sclerosis


  10. MRI - graft healing [ Time Frame: 1 year post operative ]
    Assess graft integrity: Healed or Torn

  11. MRI - tear size [ Time Frame: 1 year post operative ]
    Assess size of recurrent tear (in maximum anterior to posterior and medial to lateral dimensions). Measured in cm.

  12. MRI - fatty degeneration [ Time Frame: 1 year post operative ]

    Measured by Goutallier classification of each rotator cuff muscle:

    grade 0: normal muscle grade 1: some fatty streaks grade 2: less than 50% fatty muscle atrophy grade 3: 50% fatty muscle atrophy grade 4: greater than 50% fatty muscle atrophy




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 to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and infraspinatus.
  • Irreparable tear determined intra-operatively using standard arthroscopic techniques

Exclusion Criteria:

  • Absence of subscapularis muscle insertion, or irreparable subscapularis tear
  • Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or glenohumeral osteoarthritis (Samilson-Prieto grade 2+)
  • Acute tears (within 6 months)
  • Neurologic injury causing paralysis of affected shoulder / arm
  • Previous surgery or injury that in surgeon's opinion would compromise performance of either procedure (ie. malunion, infection, previous tendon transfer, etc.)
  • Limited life expectancy due to significant medical co- morbidity or medical contraindication to surgery (ASA Grade IV or higher)
  • Anticipated problems with ability to maintain follow-up in the judgement of the investigators (ie. patients with no fixed address, etc.)

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): NCT03617562


Contacts
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Contact: Patrick Henry, MD, FRCSC 416-967-8701 patrick.henry@sunnybrook.ca
Contact: Ryan A Paul, MD, FRCSC 7808609272 rpaul2011@gmail.com

Locations
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Canada, Ontario
Sunnybrook Holland Orthopaedic & Arthritic Centre Recruiting
Toronto, Ontario, Canada, M4Y 1H1
Contact: Patrick Henry, MD    416-967-8701    patrick.henry@sunnybrook.ca   
Contact: Ryan Paul, MD    7808609272    rpaul2011@gmail.com   
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Tim Dwyer, MD       tim.dwyer@wchospital.ca   
Contact: Elyse Watkins       research@utosm.com   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Patrick Henry, MD, FRCSC Sunnybrook Health Sciences

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03617562     History of Changes
Other Study ID Numbers: SCR2018
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries