Tendon Lengthening for Shoulder Arthritis

Overseen By Nickolas G Garbis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nickolas Garbis

Disqualifiers: Prior coracoid transfer, Revision surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 months

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Some patients may experience persistent pain in the front of their shoulder after reverse shoulder replacement. One of the possible reasons for this is that the surgery causes a change in the alignment of the shoulder joint, which may cause increased tension and compression on one of the biceps tendon called the conjoint tendon. The purpose of this study is to evaluate whether conjoint tendon lengthening, a surgical procedure that involves cutting and lengthening the conjoint tendon in order to reduce tension and compression, is able to prevent or reduce the risk of anterior shoulder pain at one year after surgery.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the treatment Prophylactic Conjoint Tendon Lengthening (CTL) for shoulder arthritis different from other treatments?

Prophylactic Conjoint Tendon Lengthening (CTL) is unique because it focuses on lengthening the tendon to address shoulder arthritis, which may help improve joint mechanics and reduce pain. This approach is different from more common treatments like joint replacement or arthroscopic procedures, which focus on repairing or replacing damaged joint structures. ^{1 2 3 4 5}

Who Is on the Research Team?

Nickolas G Garbis, MD

Principal Investigator

Loyola University

Are You a Good Fit for This Trial?

This trial is for individuals with shoulder osteoarthritis who are planning to undergo reverse shoulder replacement surgery. It aims to see if lengthening the conjoint tendon can prevent pain after surgery. Participants should not have other conditions that could affect their recovery.

Inclusion Criteria

Operations that occur at Loyola University Medical Center (Maywood, IL), Loyola Ambulatory Surgery Center (Maywood, IL), or Gottlieb Memorial Hospital

I am 18 or older and having a specific shoulder replacement surgery.

Exclusion Criteria

I am having surgery to revise a previous joint replacement.

Current pregnancy (As per standard protocol with all surgeries, a urine pregnancy test is performed prior to surgery. If positive, the surgery will be cancelled and the patient will be excluded from the research study.)

I have had a coracoid transfer surgery before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo reverse shoulder arthroplasty with or without prophylactic conjoint tendon lengthening

12 months

Regular follow-up visits as per standard surgical protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Prophylactic Conjoint Tendon Lengthening

Trial Overview The study compares standard reverse shoulder arthroplasty with a version that includes prophylactic conjoint tendon lengthening, to determine if the latter reduces post-surgical anterior shoulder pain at one year.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Prophylactic conjoint tendon lengthening in addition to reverse shoulder arthroplasty

Group II: Control Active Control 1 Intervention

Standard reverse shoulder arthroplasty

Prophylactic Conjoint Tendon Lengthening is already approved in United States for the following indications:

Approved in United States as Conjoint Tendon Lengthening for:

• Prevention or reduction of anterior shoulder pain after reverse shoulder arthroplasty

Who Is Running the Clinical Trial?

Nickolas Garbis

Lead Sponsor

Trials

1

Recruited

110+

Loyola University School of Medicine

Collaborator

Trials

2

Recruited

1,400+

Published Research Related to This Trial

The Comprehensive Arthroscopic Management (CAM) procedure is a joint-preserving surgical option for young, active patients with glenohumeral arthritis, combining multiple techniques to address various pathologies, and has shown promising survival rates of 92% at 1 year and 63% at 10 years.

Key factors influencing the success of the CAM procedure include careful patient selection and education, particularly regarding joint space and humeral head morphology, which are critical for optimizing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Arthroscopic Management of Shoulder Arthritis. Arner, JW., Ruzbarsky, JJ., Millett, PJ.[2022]

Anatomic total shoulder arthroplasty (TSA) provides significant pain relief and improves quality of life for patients with glenohumeral arthritis, particularly when nonoperative treatments have failed, as shown in a large study of patients over 55 years old.

The procedure leads to improved shoulder function, with notable increases in active range of motion and strength, alongside better patient satisfaction scores, indicating its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total Shoulder Arthroplasty Using Intraoperative 3D Navigation. Rosenthal, Y., Virk, MS., Zuckerman, JD.[2020]

In a study of 156 patients with various shoulder diagnoses, 83% experienced significant improvements in pain relief and range of motion after treatment for capsular length insufficiency using manual decompression techniques.

The research highlights that anterior capsular ligament length insufficiency can lead to abnormal shoulder mechanics and pain, suggesting that all patients with shoulder pain should be evaluated for capsular ligament length to ensure proper shoulder function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior-inferior capsular length insufficiency in the painful shoulder. Hjelm, R., Draper, C., Spencer, S.[2005]

The article presents a modified technique for conjoint tendon transfer in reconstructing the coracoclavicular ligaments (CCLs) for high-grade acromioclavicular dislocations, aiming for stable and anatomical reconstruction.

This new method addresses previous issues with dynamic instability and malreduction seen in earlier techniques, potentially improving long-term outcomes for patients with acute high-grade AC dislocations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Anatomic Coracoclavicular Ligament Reconstruction by Modified Conjoint Tendon Transfer for Treatment of Acute High-Grade Acromioclavicular Dislocation. Selim, NM.[2020]

In a study involving six cadaveric shoulders, it was found that the length of the anterior component of the glenohumeral capsuloligamentous complex significantly influences external rotation of the humerus, while the posterior component primarily affects internal rotation.

Both anterior and posterior components play a role in limiting humeral rotation at various positions, indicating that both components are important for shoulder stability and movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of glenohumeral capsular ligaments in internal and external rotation of the humerus. Branch, TP., Lawton, RL., Iobst, CA., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Arthroscopic Management of Shoulder Arthritis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Total Shoulder Arthroplasty Using Intraoperative 3D Navigation. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Anterior-inferior capsular length insufficiency in the painful shoulder. [2005]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Open Anatomic Coracoclavicular Ligament Reconstruction by Modified Conjoint Tendon Transfer for Treatment of Acute High-Grade Acromioclavicular Dislocation. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The role of glenohumeral capsular ligaments in internal and external rotation of the humerus. [2021]