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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.
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 moreTrial 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.
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Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
363 Previous Clinical Trials
628,080 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for or have had a revision reverse total shoulder arthroplasty.I need shoulder surgery for a recent upper arm bone break or its aftereffects.I am scheduled for a specific shoulder replacement surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Reverse Total Shoulder Arthroplasty
- Group 2: Reverse Total Shoulder Arthroplasty with Conjoint Tendon Resection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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