Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2022-01-31

Brief Summary

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This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff repair; bone trephination."Trephination" is a procedure that involves making small perforations 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. The control group will undergo the standard repair for rotator cuff tears.

It is the investigators' hypothesis that healing rates in patients who undergo bone trephination will be higher compared with surgery without trephination in arthroscopic rotator cuff repair at 24 months post-operatively.

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Detailed Description

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Rotator cuff repair carried out with current techniques has shown favourable results in terms of pain relief. However the re-tear rates remain high and are associated with significant morbidity in terms of functional outcome and shoulder strength. As rotator cuff disease becomes ever more prevalent with our aging population, it is imperative to determine if healing rates can be improved with autologous stem cell enhancement with pre-surgical preparation of the tendon insertion site through trephination. This trial is necessary both to provide optimal care of our patients, and to do so in a fiscally responsible fashion.

The primary outcome measure the re-tear rate as measured by ultrasound at 24 months post-operatively.

The secondary outcome measures are Western Ontario Rotator Cuff Index (WORC), Constant Score, and the American Shoulder and Elbow surgeons standardized assessment of shoulder function (ASES).

Conditions

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Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bone Trephination

For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.

Group Type ACTIVE_COMPARATOR

Bone Trephination

Intervention Type PROCEDURE

For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.

Control

Intervention Type PROCEDURE

The control group will undergo standard rotator cuff repair.

Control

The control group will undergo standard rotator cuff repair.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

The control group will undergo standard rotator cuff repair.

Interventions

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Bone Trephination

For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.

Intervention Type PROCEDURE

Control

The control group will undergo standard rotator cuff repair.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 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:
1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
2. Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc)
3. Activity modification
2. 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. Isolated subscapularis tendon tears
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 24 months
15. Advanced physiologic age

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No