A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair - Full Text View

Purpose

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	Intervention
Rotator Cuff Tear	Procedure: Bone Trephination Procedure: Soft Tissue Trephination

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:

Western Ontario Rotator Cuff Index [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Constant and ASES scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:

Ultrasound and MRI [ Time Frame: 6 weeks, 6 and 24 months ] [ Designated as safety issue: No ]
What is the difference in re-tear rate for cuff repair with adjunctive bone trephination, as measured by ultrasound, at six months and 24 months post-operatively, compared with adjunctive, pre-operative soft tissue trephination? What is the difference in the early healing reaction, as measured by T1 quantitative MRI, at 6 weeks post operatively?

Estimated Enrollment:	90
Study Start Date:	April 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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-inflammatorydrugs
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:

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.
Partial thickness cuff tears.
Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis
Previous surgery on affected shoulder e.g. Previous rotator cuff repair.
Patients with active worker's compensation claims
Active joint or systemic infection
Significant muscle paralysis
Rotator cuff tear arthropathy
Charcot's arthropathy
Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)
Major medical illness (life expectancy less then 1 year or unacceptably high operative risk)
Unable to speak or read English/French
Psychiatric illness that precludes informed consent
Unwilling to be followed for 1 year
Advanced physiologic age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706978

Contacts

Contact: Peter Lapner, MD

613-737-8377

plapner@toh.on.ca

Locations

Canada, Ontario
The Ottawa Hospital	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Lapner 613-737-8377
Principal Investigator: Peter Lapner, MD

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

More Information

No publications provided

Responsible Party:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT01706978 History of Changes
Other Study ID Numbers:	2009-042
Study First Received:	July 24, 2012
Last Updated:	October 12, 2012
Health Authority:	Ottawa Hospital Research Institute Canada':'

Keywords provided by Ottawa Hospital Research Institute:

rotator cuff tear

ClinicalTrials.gov processed this record on May 23, 2013