Clinical Trials Logo
  1. Home
  2. Shoulder Pain
  3. NCT03735173
  4. Details
NCT03735173 Clinical Trial

Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel

Shoulder Pain Clinical Trial

Official title:
Randomized Clinical Trial Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03735173
Other study ID # 17-011251
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date May 7, 2021

Study information
Verified date August 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date May 7, 2021
Est. primary completion date May 7, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Subjects willing to sign the informed consent - Male and female subjects ages 18 - 90 at the time of surgery - Subjects indicated for an anatomic total shoulder arthroplasty (including primary glenohumeral osteoarthritis, avascular necrosis, and inflammatory arthritis) Exclusion Criteria: - Inability to comply with follow-up requirements - Known or presumed substantial rotator cuff disorders - Subjects with an active or suspected latent infection in or about the shoulder - Subjects with instability (surgically or non-surgically addressed) - Subjects presenting with posttraumatic avascular necrosis - Need for glenoid bone grafting - Pregnant subjects

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ReUnion TSA, pegged design
ReUnion total shoulder arthroplasty system, pegged design
• ReUnion TSA, keeled design
ReUnion total shoulder arthroplasty system, keeled design

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Function of Subscapularis muscle as measured by belly-press test 5 years
Primary Radiographic loosening "glenoid at risk" proportion 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT04930393 - Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients N/A
Completed NCT03717753 - Rotator Cuff Pathway N/A
Completed NCT04454671 - Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment N/A
Completed NCT06274827 - Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises N/A
Not yet recruiting NCT05413213 - Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder N/A
Not yet recruiting NCT05043844 - Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder N/A
Recruiting NCT02903719 - The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection. Phase 4
Completed NCT02777281 - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI N/A
Completed NCT02554968 - Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Recruiting NCT02242630 - Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis N/A
Active, not recruiting NCT02843269 - Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM N/A
Completed NCT02631395 - The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball N/A
Completed NCT01733914 - Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain Phase 2
Completed NCT01885377 - SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain N/A
Completed NCT01205542 - Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function N/A
Completed NCT01843660 - An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain Phase 4
Completed NCT00743600 - Ultrasound Evaluation of the Rotator Cable and Associated Structures. N/A
Completed NCT00679887 - Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points Phase 1/Phase 2
Completed NCT04058522 - Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection N/A
Completed NCT03353272 - The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain N/A

External Links