Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair

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

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 Overview

• Status: Withdrawn
• Conditions: Rotator Cuff Tear; Shoulder Pain; Rotator Cuff Injury; Shoulder Pain Chronic
• Intervention / Treatment: Device: Tensor Tunnler; Procedure: Anchor Rotator Cuff Repair

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Tensor Tunnler; Create the bone tunnels during the arthroscopic rotator cuff repair procedure
ACTIVE_COMPARATOR: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2025
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (ACTUAL): January 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Rotator Cuff Injuries; Shoulder Pain
• Other Study ID Numbers: IRB00046834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No