A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair

Ottawa Hospital Research Institute

Status: Completed

Conditions: Rotator Cuff Tear

Treatments: Procedure: Soft Tissue Trephination; Procedure: Bone Trephination

Study type: Interventional

Funder types: Other

Identifiers

NCT01706978

2009042-01H

Details and patient eligibility

About

This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff repair; soft tissue and bone trephination. "Trephination" is a procedure that involves making small perforations either in the torn tendon near its edge, or in the bone that the tendon is repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon.

This study will help to determine whether this technique improves the speed of healing, the strength and the re-tear rate of the repair. You are being asked to take part in this study because you have a tear of the rotator cuff that requires surgical treatment. A total of 90 participants will participate in this study.

Enrollment: 176 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
• Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months.

Medical management will be defined as:

• The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
• Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc)
• Activity modification
• Imaging, and intra-operative findings confirming a full thickness tear of the rotator cuff.

Exclusion criteria

1. Characteristics of the cuff tear that render the cuff irrepairable: fatty infiltration in the muscles grade III (50%) or greater; superior subluxation of the humeral head; retraction of the cuff to the level of the glenoid rim.
2. Partial thickness cuff tears.
3. Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis
4. Previous surgery on affected shoulder e.g. Previous rotator cuff repair.
5. Patients with active worker's compensation claims
6. Active joint or systemic infection
7. Significant muscle paralysis
8. Rotator cuff tear arthropathy
9. Charcot's arthropathy
10. Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)
11. Major medical illness (life expectancy less then 1 year or unacceptably high operative risk)
12. Unable to speak or read English/French
13. Psychiatric illness that precludes informed consent
14. Unwilling to be followed for 1 year
15. Advanced physiologic age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 2 patient groups

Soft Tissue Trephination

Experimental group

Description:

Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.

Treatment:

Procedure: Soft Tissue Trephination

Bone Trephination

Active Comparator group

Description:

Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.

Treatment:

Procedure: Bone Trephination