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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Create the bone tunnels during the arthroscopic 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.
Johns Hopkins
Columbia, Maryland, United States
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).
Time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
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)
Time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
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.
Time frame: 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.
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
Implant Cost
Review of costs through our billing department
Time frame: Within 1 month after surgery