Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ottawa Hospital Research Institute
Sponsor:
Collaborators:
Pan Am Clinic Foundation
London Health Sciences Centre
University of Alberta
Information provided by (Responsible Party):
Dr. P. Lapner, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01877772
First received: June 12, 2013
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Rotator Cuff Tear
Procedure: Bone 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: Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • High-resolution ultrasound [ Time Frame: 6 and 24 months post op ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Functional Outcome scores [ Time Frame: baseline and 3, 6, 12, 18 and 24 months post op ] [ Designated as safety issue: No ]
    WORC, ASES and Constant


Estimated Enrollment: 166
Study Start Date: June 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Active Comparator: Control
The control group will undergo standard rotator cuff repair
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877772

Contacts
Contact: Peter Lapner, MD 613-737-8899 ext 78377

Locations
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Peter Lapner, MD    613-737-8899 ext 78377      
Principal Investigator: Peter Lapner, MD         
Sponsors and Collaborators
Dr. P. Lapner
Pan Am Clinic Foundation
London Health Sciences Centre
University of Alberta
  More Information

No publications provided

Responsible Party: Dr. P. Lapner, Orthopaedic Surgeon, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01877772     History of Changes
Other Study ID Numbers: 2013-0211
Study First Received: June 12, 2013
Last Updated: August 8, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
cuff repair
arthroscopic
Trephination
Bone
cuff tear

ClinicalTrials.gov processed this record on August 28, 2014