What side effects are associated with this type of intervention?

Common treatments for shoulder injuries, particularly those involving surgical interventions like Reverse Total Shoulder Arthroplasty (RTSA) with Conjoint Tendon Resection, can have several side effects. These may include infection, blood clots, nerve damage, and prosthesis-related issues such as loosening or dislocation. Non-surgical treatments, such as physical therapy and corticosteroid injections, may lead to temporary pain, inflammation, or, in the case of repeated steroid use, potential weakening of tendons. It is essential to discuss these potential side effects with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved various treatments for shoulder injuries, including surgical interventions and pharmacological therapies. For surgical treatments similar to RTSA with Conjoint Tendon Resection, the focus is often on procedures that aim to restore shoulder function and reduce pain in patients with massive rotator cuff tears. These may include reverse total shoulder arthroplasty (RTSA) itself, which is designed to improve shoulder mechanics and function. Pharmacological treatments often involve pain management and anti-inflammatory medications, such as corticosteroids, which can be used adjunctively to manage symptoms post-surgery. While specific FDA approvals for the conjoint tendon resection modification in RTSA are not detailed, the broader category of shoulder arthroplasty and associated pain management drugs are relevant.

What other types of research exist?

Promising novel alternatives to RTSA with Conjoint Tendon Resection for shoulder injuries include: 1) Superior Capsule Reconstruction (SCR), which has shown promise in restoring shoulder function in patients with massive rotator cuff tears. 2) Arthroscopic-assisted techniques that combine tendon transfers with biological augmentation to enhance healing and functional outcomes. 3) Stem cell and platelet-rich plasma (PRP) therapies, which are being explored for their potential to improve tissue regeneration and repair in shoulder injuries.

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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

No Placebo-Only Group

Summary

This trial compares two types of shoulder replacement surgeries in patients with severe shoulder issues. It aims to see if cutting an extra tendon during surgery helps improve the ability to move the arm behind the back.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Functional Internal Shoulder Rotation Over Time Points

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for shoulder injuries include surgical interventions like reverse total shoulder arthroplasty (RTSA), which replaces the damaged shoulder joint with a prosthesis to restore movement and reduce pain. Conjoint tendon resection, a modification of RTSA, aims to improve functional internal rotation by altering the tendon structure to enhance the range of motion. Physical therapy focuses on strengthening and stabilizing the shoulder muscles to support recovery and prevent further injury. Biologic therapies, such as platelet-rich plasma (PRP) injections, promote healing by using concentrated platelets to accelerate tissue repair. These treatments are crucial for shoulder injury patients as they address both pain relief and functional improvement, enabling better quality of life and return to daily activities.

Early versus delayed mobilization following rotator cuff repair.