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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

Brief Summary:

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 or disease Intervention/treatment Phase
Rotator Cuff Tear Procedure: Bone Trephination Procedure: Control Not Applicable

Detailed Description:

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled
Study Start Date : June 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
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.

Procedure: Control
The control group will undergo standard rotator cuff repair.

Active Comparator: Control
The control group will undergo standard rotator cuff repair.
Procedure: Control
The control group will undergo standard rotator cuff repair.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Functional Outcome scores [ Time Frame: baseline and 3, 6, 12, 18 and 24 months post op ]
    WORC, ASES and Constant



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877772


Contacts
Contact: Peter Lapner, MD 613-737-8899 ext 78377
Contact: Research Team 613-737-8920

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
Ottawa Hospital Research Institute
Panam Clinic
London Health Sciences Centre
University of Alberta
Investigators
Principal Investigator: Peter Lapner, MD OHRI

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01877772     History of Changes
Other Study ID Numbers: 2013-0211
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries