Clinical Trials Logo

Clinical Trial Summary

To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears.


Clinical Trial Description

A total of 60 patients will be enrolled in the study. In the pre-operative period, there will be no additional time requirements for the patient, except for the informed consent process for the study. Routine radiographs including an AP and Y view of the shoulder as well as a pre-operative MRI are obtained for all patients undergoing rotator cuff surgery. The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant. The examination will consist of range of motion testing by goniometer as well as strength testing by hand dynamometer. The patient will also complete the WORC questionnaire. Surgical Technique All patients will undergo a 15-point arthroscopic shoulder examination as per the method outlined by Snyder. An arthroscopic acromioplasty will be performed if needed according to the technique described by Snyder. The bursal side of the tear will be evaluated. If the cuff can be re-approximated to its anatomic position on the greater tuberosity without excessive tension, a standard rotator cuff reconstruction will be attempted. If this is not possible the surgeon will determine that the cuff is "irreparable" and the randomization envelope will be opened. Wong et al. described the surgical procedure for patients in the "Bridging" group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed into the remnants of supraspinatus and infraspinatus tendons. The patch is then attached to the greater tuberosity in a double row configuration. The technique described by Burkhart et al will be followed for patients in the "SCR" group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities. Measurement of defect size (coronal and sagittal) will take place, following that the glenoid and humeral footprint preparation will be performed utilizing an arthroscopic burr, arthroscopic bone anchors will be inserted on the glenoid footprint and graft is inserted with double pully technique. The graft is then tensioned to greater tuberosity using a double row configuration. Postoperative protocol The shoulder will be immobilized in a sling for one week postoperatively, and only passive forward flexion and external rotation will be allowed for eight weeks. The patient then progresses to active shoulder motion. Strengthening will begin at twelve weeks postoperatively. The patient will follow-up with the attending surgeon (IW) at 2 weeks post-operatively for a wound check. Then further follow-up appointments will be at 6 weeks, 3 months, 6 months, 12 and 24 months, as per current clinical practice. At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant who is blinded to the patients' treatment group. The patient will also complete the (WORC) questionnaire at these follow-up appointments. Radiograph will be taken also to obtain the postoperative measurements. MRI will be done to assess healing at 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03425500
Study type Interventional
Source Nova Scotia Health Authority
Contact
Status Active, not recruiting
Phase N/A
Start date May 1, 2018
Completion date August 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06105398 - the Effect of Core Stability on Hand Functions
Completed NCT01778777 - Safety Study of Univers® Revers Shoulder Prosthesis N/A
Recruiting NCT05002335 - Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Active, not recruiting NCT02588027 - Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder N/A
Withdrawn NCT01873651 - Longterm Outcome of the Delta III Inverse Prosthesis Phase 4
Not yet recruiting NCT04093804 - Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty N/A
Recruiting NCT04529798 - Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
Completed NCT01954433 - Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity
Recruiting NCT05438914 - Subscapularis Repair in Reverse Shoulder Arthroplasty N/A
Withdrawn NCT03488433 - Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair N/A
Not yet recruiting NCT06292169 - Pectoralis Minor Release Versus Non-release in RSA N/A
Not yet recruiting NCT05355844 - Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery N/A
Completed NCT01687894 - Vasopressin to Prevent Hypotension During Beach Chair Surgery N/A
Enrolling by invitation NCT01405781 - Functional and Radiographic Outcomes After Shoulder Surgery
Completed NCT03111147 - Impact of Humeral Component Version on Outcomes Following RTSA N/A
Active, not recruiting NCT02679352 - SMR Stemless Shoulder Arthroplasty Clinical Study N/A
Recruiting NCT05926622 - Clinical and Radiological Outcomes of Medacta Shoulder System FR
Recruiting NCT03547947 - Clinical and Radiological Outcomes of Medacta Shoulder System
Withdrawn NCT04285606 - Effect of Postop Rehab Methods on Outcomes Following Reverse Shoulder Arthroplasty N/A
Completed NCT02512536 - Does Botulinum A Toxin Help With Pain From Rotator Cuff Arthropathy? Phase 2