Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair

NCT ID: NCT03797287

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tensor Tunnler

Intervention Type: DEVICE

Create the bone tunnels during the arthroscopic rotator cuff repair procedure

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).

Group Type: ACTIVE_COMPARATOR

Anchor Rotator Cuff Repair

Intervention Type: 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.

Interventions

Tensor Tunnler

Create the bone tunnels during the arthroscopic rotator cuff repair procedure

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults age 18-75 years old
• Full thickness rotator cuff tears of any size (documented by MRI or ultrasound)
• Patients planning surgical repair with Dr. Uma Srikumaran (PI of this study) at Johns Hopkins Shoulder Service (Columbia, Odenton Clinic sites; Howard County General Hospital/Bayview/Johns Hopkins Hospital operative sites)

Exclusion Criteria

• Patients with partial tears, massive rotator cuff tears that are irreparable, isolated subscapularis tears, and associated pathology (advanced degenerative changes)
• Patients undergoing revision rotator cuff tears will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uma Srikumaran, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins

Columbia, Maryland, United States

Countries

United States

Other Identifiers

IRB00046834

Identifier Type: -

Identifier Source: org_study_id