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IRB will be terminated
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This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.
Study Design: After the decision to proceed with arthroscopic rotator cuff repair, patients will be asked to participate in this prospective randomized clinical trial.
Study Procedures:
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.
Patient Visits:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tensor Tunnler | Experimental | 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. |
|
| Smith and Nephew PEEK Helicoil Anchor | Active Comparator | The anchors used in this trial are FDA approved and are used currently in routine clinical practice (Anchor Rotator Cuff Repair). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tensor Tunnler | Device | Create the bone tunnels during the arthroscopic rotator cuff repair procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score | 10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties). | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in shoulder pain as assessed by Visual Analog Pain Score | 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) | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uma Srikumaran, MD, MBA | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins | Columbia | Maryland | 21044 | United States |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| Anchor Rotator Cuff Repair | Procedure | 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 Range of Motion (ROM) | 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. | Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year |
| Change in Strength Testing | 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. | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery |
| Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index | 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. | Before surgery, 1 year after surgery, 2 years after surgery |
| Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D) | 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. | Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery |
| Implant Cost | Review of costs through our billing department | Within 1 month after surgery |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |