A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Ottawa Hospital Research Institute
Sponsor:
Collaborator:
University of Ottawa
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01706978
First received: July 24, 2012
Last updated: September 8, 2014
Last verified: September 2014

July 24, 2012
September 8, 2014
April 2012
December 2014   (final data collection date for primary outcome measure)
Western Ontario Rotator Cuff Index [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01706978 on ClinicalTrials.gov Archive Site
Constant and ASES scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
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?
Same as current
 
A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair
A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair: Soft Tissue or Bone Trephination, a Prospective Cohort Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Rotator Cuff Tear
  • Procedure: Bone Trephination
  • Procedure: Soft Tissue Trephination
  • 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.
    Intervention: 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.
    Intervention: Procedure: Bone Trephination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2014
December 2014   (final data collection date for primary outcome measure)

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:

  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
Both
18 Years to 90 Years
No
Contact: Peter Lapner, MD 613-737-8377 plapner@toh.on.ca
Canada
 
NCT01706978
2009-042
Yes
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
University of Ottawa
Principal Investigator: Peter Lapner, MD The Ottawa Hospital
Principal Investigator: Guy Trudel, MD University of Ottawa
Ottawa Hospital Research Institute
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP