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Conjoint Tendon Resection for Frozen Shoulder

N/A

Recruiting

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all participants were be surveilled per standard of care at our hospital for the targeted patient group. patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years.

Awards & highlights

Study Summary

This trial compares 2 surgical approaches for RTSA to see which best restores the ability to move the hand behind the body.

Who is the study for?

This trial is for patients who are having their first reverse total shoulder arthroplasty (RTSA), a type of shoulder replacement surgery. It's not open to those needing revision RTSA or RTSA due to an acute fracture or its after-effects.Check my eligibility

What is being tested?

The study compares the usual surgical method for RTSA with a variation where the conjoint tendon is removed. The focus is on improving how well patients can move their hand behind their body post-surgery.See study design

What are the potential side effects?

While specific side effects aren't listed, typical risks may include pain, swelling, limited range of motion, infection risk at the surgery site, and possible damage to nearby nerves or blood vessels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all participants were be surveilled per standard of care at our hospital for the targeted patient group. patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all participants were be surveilled per standard of care at our hospital for the targeted patient group. patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and all participants were be surveilled per standard of care at our hospital for the targeted patient group. patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Functional Internal Shoulder Rotation Over Time Points

Secondary outcome measures

Change in American Shoulder and Elbow (ASES) Score Over Time Points

Change in Patient Reported Outcome Information System (PROMIS) Score Over Time Points

Change in Single Assessment Numeric Evaluation (SANE) Score Over Time Points

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Reverse Total Shoulder Arthroplasty with Conjoint Tendon ResectionExperimental Treatment1 Intervention

RTSA in the experimental group will be identical, except for that after definitive implantation of the prosthesis is completed, in the 'experimental' group, the conjoint tendon will be released completely via a transverse incision made at a level 2 cm distal to the coracoid process for the patients assigned the conjoint resection group. Electrocautery will be used for the resection, and the underlying muscular portion of the conjoint tendon will be preserved. As mentioned above, the control group will not receive this conjoint tendon resection. Similarly, in the experimental group, the wound will be closed in layers, and the shoulder will be immobilized in an abduction sling.

Group II: Reverse Total Shoulder ArthroplastyActive Control1 Intervention

For RTSA using a deltopectoral approach, the Perform glenoid and humeral components of Tornier Stryker Reverse Shoulder system will be used for all cases. The sizes and offsets of the components will be chosen based on each patient's local anatomy which will vary among patients. The subscapularis tendon will be repaired using three transosseous nonabsorbable sutures whenever there is a reparable subscapularis tendon. After definitive implantation of the prosthesis is completed, in the 'no interventional' group, the wound will be closed in layers, and the shoulder will be immobilized in an abduction sling.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

362 Previous Clinical Trials

628,050 Total Patients Enrolled

Media Library

Conjoint Tendon Resection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05753904 — N/A

Shoulder Injuries Research Study Groups: Reverse Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty with Conjoint Tendon Resection

Shoulder Injuries Clinical Trial 2023: Conjoint Tendon Resection Highlights & Side Effects. Trial Name: NCT05753904 — N/A

Conjoint Tendon Resection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753904 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are signing up to join this research endeavor?

"Affirmative. Clinicaltrials.gov has records of this exploratory study, which was initially published on March 1st 2023 and recently revised on the 7th of the same month. 64 individuals need to be recruited at one location for full participation in the trial."

Answered by AI

Are any positions available to participants in this research project?

"Affirmative. According to clinicaltrials.gov, this medical study is currently seeking recruits with its initial posting date of March 1st 2023 and most recent update on the 7th of that same month. This trial requires 64 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty

Charles Gusho, MD 2023. "Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05753904.

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