se of Acellular Human Dermal Allograft Patch for Augmentation of Rotator Cuff Repair - A Randomised Controlled Trial

Not Applicable

Recruiting

• Conditions: Rotator cuff tear; Musculoskeletal - Other muscular and skeletal disorders; Surgery - Other surgery

• Registration Number: ACTRN12623001350617
• Lead Sponsor: St. John of God Healthcare Subiaco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-21
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Diagnosis of rotator cuff tear confirmed radiologically by MRI to be full-thickness, greater than or equal to 4cm, involve two or more tendons and be repairable.
- Adequate pre-operative function of the uninjured arm.
- Ability to understand and participate in the trial including ability to understand and complete the patient reported outcome measures (PROMs).
- Ability to participate in regular rehabilitation post-operatively.
- Age 18-75 years.
- Medically fit for surgery with general anaesthetic.

Exclusion Criteria

Age less than 18 years or greater than 75 years.
- Any previous surgical repair to the injured shoulder
- Neuromuscular disorders (for example, myasthenia gravis, Lambert-Eaton, amyotrophic lateral sclerosis et cetera).
- Upper extremity dysfunction due to a neurological or medical cause (for example, due to a cerebrovascular accident or traumatic brain injury, diabetic neuropathy et cetera).
- Unfit for general anaesthesia.
- Evidence of active infection or cancer.
- Current smoker.
- Current use of immunosuppressing medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional shoulder outcome following surgical repair of rotator cuff[The Univerity of California Los Angeles Shoulder Score 6 weeks, 3 months, 6 months, 12 months, and 24 months post-operation];Functional shoulder outcome following surgical repair of rotator cuff[Subjective Shoulder Value 6 weeks, 3 months, 6 months, 12 months, and 24 months post-operation];Functional shoulder outcome following surgical repair of rotator cuff [American Shoulder and Elbow Surgeons Score 6 weeks, 3 months, 6 months, 12 months, and 24 months post-operation]

Secondary Outcome Measures

Name	Time	Method
Adverse events such as pain, or infection.[Self-reporting of a questionnaire via telephone call or in-person in clinic at follow-up appointments. 6 weeks, 3, 6, 12, and 24 months post-operation];MRI assessment of rotator cuff[MRI 12 months post-operation]