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Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT03797287
Recruitment Status : Withdrawn (IRB will be terminated)
First Posted : January 9, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Chronic Shoulder Pain Rotator Cuff Tear Rotator Cuff Injury Device: Tensor Tunnler Procedure: Anchor Rotator Cuff Repair Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair: A Randomized Clinical Trial
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

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.




Primary Outcome Measures :
  1. Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score [ Time Frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery ]
    10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties).


Secondary Outcome Measures :
  1. Change in shoulder pain as assessed by Visual Analog Pain Score [ Time Frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery ]
    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)

  2. Change in Range of Motion (ROM) [ Time Frame: Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year ]
    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.

  3. Change in Strength Testing [ Time Frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery ]
    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.

  4. Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index [ Time Frame: Before surgery, 1 year after surgery, 2 years after surgery ]
    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.

  5. Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D) [ Time Frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery ]
    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.

  6. Implant Cost [ Time Frame: Within 1 month after surgery ]
    Review of costs through our billing department



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797287


Locations
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United States, Maryland
Johns Hopkins
Columbia, Maryland, United States, 21044
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Uma Srikumaran, MD, MBA Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03797287     History of Changes
Other Study ID Numbers: IRB00046834
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Shoulder Pain
Rotator Cuff Injuries
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries