NCT03797287

Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair

Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair: A Randomized Clinical Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Shoulder Pain Chronic
• Shoulder Pain
• Rotator Cuff Tear
• Rotator Cuff Injury

Interventions

Type	Name	Description
DEVICE	Tensor Tunnler	Create the bone tunnels during the arthroscopic rotator cuff repair procedure
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.

Timeline

• Start date: 2020-02-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2019-01-09
• Last updated: 2019-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study