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Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bone Trephination
Control
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring cuff repair, arthroscopic, Trephination, Bone, cuff tear

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bone Trephination

Control

Arm Description

For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.

The control group will undergo standard rotator cuff repair.

Outcomes

Primary Outcome Measures

High-resolution ultrasound
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
WORC, ASES and Constant

Full Information

First Posted
June 12, 2013
Last Updated
March 1, 2023
Sponsor
Ottawa Hospital Research Institute
Collaborators
Panam Clinic, London Health Sciences Centre, University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01877772
Brief Title
Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled
Official Title
Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
November 2020 (Actual)
Study Completion Date
January 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Panam Clinic, London Health Sciences Centre, University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
cuff repair, arthroscopic, Trephination, Bone, cuff tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bone Trephination
Arm Type
Active Comparator
Arm Description
For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will undergo standard rotator cuff repair.
Intervention Type
Procedure
Intervention Name(s)
Bone Trephination
Intervention Description
For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
The control group will undergo standard rotator cuff repair.
Primary Outcome Measure Information:
Title
High-resolution ultrasound
Description
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.
Time Frame
6 and 24 months post op
Secondary Outcome Measure Information:
Title
Functional Outcome scores
Description
WORC, ASES and Constant
Time Frame
baseline and 3, 6, 12, 18 and 24 months post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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-inflammatory drugs 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. Isolated subscapularis tendon tears 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 24 months Advanced physiologic age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lapner, MD
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada

12. IPD Sharing Statement

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Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

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