Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

Rotator Cuff Tear Clinical Trial

Official title:

Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877772
• Other study ID #: 2013-0211
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: January 2022

Study information

• Verified date: March 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 2022
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Procedure:
• 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.
• Control
The control group will undergo standard rotator cuff repair.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	London Health Sciences Centre, Panam Clinic, University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High-resolution ultrasound	High-resolution ultrasound will be used as the primary outcome measure to determine the re-tear rate at 6 and 24 months following repair. Ultrasound was chosen as it has been shown to have a high degree of accuracy for the diagnosis of rotator tears that is equivalent but less expensive than MRI.; The interpretation of the high-resolution ultrasound is based on healing status and will be carried out by a trained MSK radiologist. Healing status will be documented at both 6 and 24 months as either completely healed, partially healed, or not healed. For tendons partially healed or not healed, the size of the defect will be compared with the size of the tear pre-operatively.	6 and 24 months post op
Secondary	Functional Outcome scores	WORC, ASES and Constant	baseline and 3, 6, 12, 18 and 24 months post op