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Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

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ClinicalTrials.gov Identifier: NCT01877772
Recruitment Status : Recruiting
First Posted : June 14, 2013
Last Update Posted : October 1, 2018
Sponsor:
Collaborators:
Panam Clinic
London Health Sciences Centre
University of Alberta
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

June 12, 2013
June 14, 2013
October 1, 2018
June 2013
December 2019   (Final data collection date for primary outcome measure)
High-resolution ultrasound [ Time Frame: 6 and 24 months post op ]

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.

Same as current
Complete list of historical versions of study NCT01877772 on ClinicalTrials.gov Archive Site
Functional Outcome scores [ Time Frame: baseline and 3, 6, 12, 18 and 24 months post op ]
WORC, ASES and Constant
Same as current
Not Provided
Not Provided
 
Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled
Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

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.

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).

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Rotator Cuff Tear
  • 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.
  • Procedure: Control
    The control group will undergo standard rotator cuff repair.
  • 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.
    Interventions:
    • Procedure: Bone Trephination
    • Procedure: Control
  • Active Comparator: Control
    The control group will undergo standard rotator cuff repair.
    Intervention: Procedure: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
166
Same as current
December 2019
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
No
Contact: Peter Lapner, MD 613-737-8899 ext 78377
Contact: Research Team 613-737-8920
Canada
 
 
NCT01877772
2013-0211
No
Not Provided
Not Provided
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
  • Panam Clinic
  • London Health Sciences Centre
  • University of Alberta
Principal Investigator: Peter Lapner, MD OHRI
Ottawa Hospital Research Institute
September 2018

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