NCT03617562

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, its effectiveness, cost and safety profile have 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jul 2018Jul 2028

First Submitted

Initial submission to the registry

May 7, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

8 years

First QC Date

May 7, 2018

Last Update Submit

September 11, 2024

Conditions

Rotator Cuff Tear

Keywords

Massive Rotator Cuff TearShoulder Injuries

Outcome Measures

Primary Outcomes (1)

  • The American Shoulder and Elbow Surgeons Shoulder Score (ASES)

    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)

    1 year post operative

Secondary Outcomes (12)

  • Complication rate

    1 year post operative

  • Recruitment rate

    1 year post operative

  • Constant-Murley Score

    1 year post operative

  • Western Ontario Rotator Cuff Index

    1 year post operative

  • Pain: Numeric Rating Scale

    1 year post operative

  • +7 more secondary outcomes

Study Arms (2)

Superior Capsular Reconstruction

EXPERIMENTAL

Patients will be treated with the new technique of superior capsular reconstruction with dermal allograft.

Procedure: Superior Capsular Reconstruction

Partial Repair

ACTIVE COMPARATOR

Patients will have a partial repair with residual defect as an established standard procedure.

Procedure: Partial Repair

Interventions

Superior Capsular ReconstructionPROCEDURE

Residual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head.

Superior Capsular Reconstruction
Partial RepairPROCEDURE

Rotator cuff is repaired with residual defect remaining.

Partial Repair

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic shoulder pain and/ or weakness (regardless of baseline range of motion/ psuedoparalysis)
  • Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and infraspinatus.
  • Failure of at least a 3 month trial of non-surgical treatment including physiotherapy and activity modifications
  • Irreparable tear determined intra-operatively using standard arthroscopic techniques
  • Informed consent obtained

You may not qualify if:

  • 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
  • Any previous surgery to the affected shoulder
  • 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.)
  • Are there any non-orthopedic comorbidities that put the patient at significant risk?

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook Holland Orthopaedic & Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

RECRUITING

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

RECRUITING

MeSH Terms

Conditions

Rotator Cuff InjuriesShoulder Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesTendon Injuries

Study Officials

  • Patrick Henry, MD, FRCSC

    Sunnybrook Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Henry, MD, FRCSC

CONTACT

416-967-8701patrick.henry@sunnybrook.ca

Ryan A Paul, MD, FRCSC

CONTACT

7808609272rpaul2011@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

August 6, 2018

Study Start

July 18, 2018

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2028

Last Updated

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)