A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair

• ClinicalTrials.gov Identifier: NCT01706978
• Recruitment Status: Completed
• First Posted: October 15, 2012
• Results First Posted: May 6, 2020
• Last Update Posted: September 18, 2020
• Sponsor: Ottawa Hospital Research Institute
• Collaborator: University of Ottawa
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Tear	Procedure: Bone Trephination; Procedure: Soft Tissue Trephination	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair: Soft Tissue or Bone Trephination, a Prospective Cohort Study
• Actual Study Start Date: April 2012
• Actual Primary Completion Date: September 2018
• Actual Study Completion Date: September 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Soft Tissue Trephination; 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.	Procedure: Soft Tissue Trephination
Active Comparator: Bone Trephination; 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.	Procedure: Bone Trephination

Outcome Measures

Primary Outcome Measures :

1. Western Ontario Rotator Cuff Index [ Time Frame: From baseline to up until 24-Months Post-Operative ]
   The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.

Secondary Outcome Measures :

1. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores [ Time Frame: From baseline to up until 24-Months Post-Operative ]
   The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
2. The Constant Score [ Time Frame: From baseline to up until 24-Months Post-Operative ]
   The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
3. Healing Rates [ Time Frame: From surgery to up until 24-Months Post-Operative ]
   Imaging parameters will be examined using ultrasound and magnetic resonance imaging (MRI). These images will be analyzed to determine healing status of the tissues post-operatively. Imaging will determine whether the tissue is healed, partially torn, or fully torn after surgery. Higher incidence of tearing will be compared between groups. A higher incidence of tearing indicates worse outcomes.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Sponsors and Collaborators

Ottawa Hospital Research Institute

University of Ottawa

Investigators

• Principal Investigator: Peter Lapner, MD; The Ottawa Hospital
• Principal Investigator: Guy Trudel, MD; University of Ottawa

  Study Documents (Full-Text)

Documents provided by Ottawa Hospital Research Institute:

Study Protocol and Statistical Analysis Plan  [PDF] July 8, 2015

More Information

Publications of Results:

Campbell TM, Lapner P, Dilworth FJ, Sheikh MA, Laneuville O, Uhthoff H, Trudel G. Tendon contains more stem cells than bone at the rotator cuff repair site. J Shoulder Elbow Surg. 2019 Sep;28(9):1779-1787. doi: 10.1016/j.jse.2019.02.008. Epub 2019 Apr 26.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01706978
• Other Study ID Numbers: 2009042-01H
• First Posted: October 15, 2012
• Results First Posted: May 6, 2020
• Last Update Posted: September 18, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:

rotator cuff tear

Additional relevant MeSH terms:

Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries