Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair
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|ClinicalTrials.gov Identifier: NCT03797287|
Recruitment Status : Withdrawn (IRB will be terminated)
First Posted : January 9, 2019
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain Chronic Shoulder Pain Rotator Cuff Tear Rotator Cuff Injury||Device: Tensor Tunnler Procedure: Anchor Rotator Cuff Repair||Not Applicable|
Study Design: After the decision to proceed with arthroscopic rotator cuff repair, patients will be asked to participate in this prospective randomized clinical trial.
Before Surgery: The Informed Consent process will be completed prior to any data collection. Consent will be completed after explanation of each treatment group and the data to be collected. Baseline and demographic data will be collected prior to surgery:
Randomization: Subjects will be randomized prior to surgery into one of the two rotator cuff repair technique groups using REDCap software. Randomization will be stratified by gender.
Patients will complete their questionnaires and testing before surgery then within 2 weeks, 3 months, 6 months, 1 year, and 2 years After the first week of surgery, patients will be given a pain diary to record all narcotic pain medications they consume during the 1st week post-op.
An ultrasound will be done during their 6 month, 1 year, and 2 year follow up.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair: A Randomized Clinical Trial|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: Tensor Tunnler
The Tensor Tunneler (Chattanooga, TN) will be used to create the bone tunnels during the arthroscopic procedure. This is an FDA approved device and is used currently in routine clinical practice.
Device: Tensor Tunnler
Create the bone tunnels during the arthroscopic rotator cuff repair procedure
Active Comparator: Smith and Nephew PEEK Helicoil Anchor
The anchors used in this trial are FDA approved and are used currently in routine clinical practice (Anchor Rotator Cuff Repair).
Procedure: Anchor Rotator Cuff Repair
The suture anchors (Smith and Nephew PEEK Helicoil Anchor) are inserted in bone and the sutures are then used to sew the tendons to bone arthroscopically.
- Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score [ Time Frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery ]10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties).
- Change in shoulder pain as assessed by Visual Analog Pain Score [ Time Frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery ]Patients are asked to identify whether they are having pain in the shoulder and are asked to record the location of their pain on a 10 cm line that ranges from 0(no pain at all) to 10 (pain as bad as it can be)
- Change in Range of Motion (ROM) [ Time Frame: Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year ]Total (combined glenohumeral and scapulothoracic) shoulder motion is measured. Both active and passive motion for both shoulders is recorded. Forward elevation is measured as the maximum arm-trunk angle viewed from any direction. External rotation is measured with the arm comfortably at the side and also with the arm at 90° of abduction. Internal rotation is measured by noting the highest segment of spinal anatomy reached with the thumb. Cross-body adduction is measured by measuring the distance of the antecubital fossa from the opposite acromion.
- Change in Strength Testing [ Time Frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery ]Strength is graded according to the Medical Research Council grade. Strength is measured in forward elevation, abduction, external rotation with the arm comfortably at the side, and internal rotation with the arm comfortably at the side. A perfect score is a 5 in each category.
- Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index [ Time Frame: Before surgery, 1 year after surgery, 2 years after surgery ]Quality of Life Measurement tool for patients with rotator cuff disease where patients mark a line on 21 visual analogue scale (VAS) lines labeled 0 (not affected) - 100 (affected). These items will ask about physical symptoms, sports and recreation, work, social function, and emotions. The maximum score is 2100 for worst possible symptoms and 0 represents no symptoms at all.
- Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D) [ Time Frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery ]Measures of health related quality of life (HRQoL) using 11 items from the SF-36 or SF-12. Patients are asked about their physical functioning, role limitations, social functioning, pain, mental health, and vitality. A score of 1 represents full health.
- Implant Cost [ Time Frame: Within 1 month after surgery ]Review of costs through our billing department
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): NCT03797287
|United States, Maryland|
|Columbia, Maryland, United States, 21044|
|Principal Investigator:||Uma Srikumaran, MD, MBA||Johns Hopkins University|