Conjoint Tendon Resection for Frozen Shoulder

Overseen By H. Mike Kim, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Revision RTSA, Acute fracture, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Immediate post-surgery

64 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Conjoint Tendon Resection for Frozen Shoulder?

The study on conjoint tendon release for persistent shoulder pain after reverse total shoulder arthroplasty suggests that this treatment can be effective for relieving pain in patients with similar shoulder conditions. ^{1 2 3 4 5}

Is conjoint tendon resection generally safe for humans?

There is limited safety data specifically for conjoint tendon resection, but a study on conjoint tendon release for shoulder pain after reverse total shoulder arthroplasty suggests it is used in humans. However, complications like infection and instability are noted in related shoulder procedures. ^{1 6 7 8 9}

How does the treatment Conjoint Tendon Resection for Frozen Shoulder differ from other treatments?

Conjoint Tendon Resection is unique because it involves the surgical removal or release of the conjoint tendon during reverse total shoulder arthroplasty, which is a procedure typically used to address complex shoulder issues like rotator cuff tears. This approach may offer a novel solution for frozen shoulder by potentially improving shoulder mobility and function, especially in cases where traditional treatments are ineffective. ^{2 10 11 12 13}

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for a specific shoulder replacement surgery.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Reverse Total Shoulder Arthroplasty (RTSA) with or without conjoint tendon resection

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of functional internal rotation and various health scores

2 years

Visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years (in-person)

Treatment Details

Interventions

• Conjoint Tendon Resection

Trial Overview 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.

Participant Groups

Group I: Reverse Total Shoulder Arthroplasty with Conjoint Tendon Resection Experimental Treatment 1 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 Arthroplasty Active Control 1 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.

Conjoint Tendon Resection is already approved in United States, European Union for the following indications:

Approved in United States as Conjoint Tendon Resection during Reverse Total Shoulder Arthroplasty for:

• Improvement of functional internal rotation in patients undergoing reverse total shoulder arthroplasty

Approved in European Union as Conjoint Tendon Resection during Reverse Total Shoulder Arthroplasty for:

• Enhancement of postoperative functional internal rotation in reverse total shoulder arthroplasty patients

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Findings from Research

Open conjoint tendon release is an effective treatment for persistent anterior shoulder pain due to conjoint tendinitis after reverse total shoulder arthroplasty (RTSA), with significant improvements in pain and shoulder function reported by patients.

In a study of 11 patients followed for an average of 27 months, 45% experienced some coracoid pain post-surgery, but overall, there were no complications or reoperations, indicating the procedure's safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conjoint tendon release for persistent anterior shoulder pain following reverse total shoulder arthroplasty. Tashjian, RZ., Frandsen, JJ., Christensen, GV., et al.[2022]

Reverse shoulder arthroplasty significantly alters the center of rotation (COR) of the shoulder joint, moving it inferiorly by an average of 12 mm and medially by 27 mm post-surgery, which can impact muscle tension and function.

The change in COR varies between different implant designs, with the Delta prosthesis showing a greater medial displacement compared to the Encore prosthesis, indicating that the choice of implant may influence postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A method for documenting the change in center of rotation with reverse total shoulder arthroplasty and its application to a consecutive series of 68 shoulders having reconstruction with one of two different reverse prostheses. Saltzman, MD., Mercer, DM., Warme, WJ., et al.[2016]

Reverse shoulder arthroplasty showed significantly fewer complications (8%) and reoperations (4%) compared to anatomic total shoulder arthroplasty, which had complication and reoperation rates of 24% and 23%, respectively, over an average follow-up of 8.8 years.

Despite anatomic total shoulder arthroplasty providing greater overhead range of motion and external rotation, patients who underwent reverse shoulder arthroplasty reported higher satisfaction rates, with 90% rating their shoulder as much better or better compared to 67% in the anatomic group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomic versus reverse shoulder arthroplasty: a mid-term follow-up comparison. Schoch, BS., King, JJ., Zuckerman, J., et al.[2022]

Reverse total shoulder arthroplasty significantly improves pain management and functional outcomes in elderly patients with rotator cuff arthropathy, achieving a mean Constant score of 81.2% after an average follow-up of 53 months.

Despite these improvements, patients may still experience limitations in daily life activities, particularly those requiring internal rotation or high functional demand, affecting 20% and 51% of patients respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported activities after reverse total shoulder arthroplasty in rotator cuff arthropathy patients. Alcobía-Díaz, B., Lópiz, Y., García-Fernández, C., et al.[2018]

In a study of 110 patients who underwent revision shoulder arthroplasty, the procedure showed a 92% implant survival rate at 2 years and 74% at 5 years, indicating a reasonable long-term success rate.

Despite achieving modest functional outcomes and a satisfaction rate of 70%, complications occurred in 20% of patients, highlighting the risks associated with revision surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revision of failed hemiarthroplasty and anatomic total shoulder arthroplasty to reverse total shoulder arthroplasty. Sheth, MM., Sholder, D., Getz, CL., et al.[2019]

In a study of 116 shoulders undergoing rotator cuff repair, complications occurred in 38% of cases, highlighting a significant concern for patients and surgeons.

Major surgical complications, which could impact the final outcome, were observed in 16% of shoulders, with frozen shoulder, deep infection, and dislocation being the most common issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of rotator cuff repair. Mansat, P., Cofield, RH., Kersten, TE., et al.[2022]

In a study of 133 shoulders from 121 patients who underwent reverse shoulder arthroplasty, 50.4% developed scapular notches after 2 years, which were associated with poorer functional scores.

The risk of developing notches was significantly lower when the glenosphere overhang was more than 3mm and when the glenometaphyseal angle was less than 28°, indicating that proper positioning of the glenoid component is crucial for reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors of scapular notching in patients with reverse shoulder arthroplasty. Bigorre, N., Lancigu, R., Bizot, P., et al.[2018]

The complication rate for reverse shoulder arthroplasty (RSA) is around 4%, with the most common issues being instability, infection, component loosening, and periprosthetic fractures.

Revision surgeries for RSA are complex and require tailored treatment plans, especially for complications like prosthetic instability and infections, highlighting the importance of understanding risk factors to potentially reduce future complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Revision surgery in reverse shoulder arthroplasty : Management of the most common complications]. Wittmann, T., Raiss, P.[2023]

In a study of 57 patients who underwent staged bilateral reverse shoulder arthroplasty (RSA), 21% experienced insufficient internal rotation (IR) one year after the first surgery, which increased to 33% after the second surgery, indicating a potential risk for rotational deficits post-operation.

Factors such as pre-existing insufficient IR and poor function after the first RSA were associated with a higher likelihood of insufficient IR after the second surgery, but overall functional outcomes improved by two years, suggesting that staged surgery can be beneficial when the first operation is successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of insufficient internal rotation after bilateral reverse shoulder arthroplasty: clinical and patient-reported outcome in 57 patients. Wirth, B., Kolling, C., Schwyzer, HK., et al.[2022]

In a study of 5 patients with deltoid tears who underwent reverse total shoulder arthroplasty (RTSA) combined with deltoid reconstruction, significant improvements in shoulder motion and function were observed, with forward elevation increasing from 48° to 120° and Penn Shoulder Scores rising from 45.2 to 77.8 after surgery.

The procedure demonstrated a low rate of complications, with only one case of recurrent deltoid failure and no infections or revisions, suggesting that this combined approach is a safe and effective option for patients with deltoid deficiency requiring RTSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reverse total shoulder arthroplasty with combined deltoid reconstruction in patients with anterior and/or middle deltoid tears. Marinello, PG., Amini, MH., Peers, S., et al.[2018]

In a unique case, a patient with deltoid palsy, an irreparable rotator cuff tear, and glenohumeral arthritis successfully underwent reverse shoulder arthroplasty combined with pectoralis major and trapezius muscle transfers.

This approach suggests that even in challenging cases where traditional RSA is contraindicated, innovative surgical techniques can lead to satisfactory outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review and clinical presentation in reverse shoulder arthroplasty in deltoid palsy. Kermarrec, G., Werthel, JD., Canales, P., et al.[2018]

Reverse total shoulder arthroplasty, while effective for rotator cuff issues, has a higher risk of infection compared to other shoulder surgeries, such as hemiarthroplasty.

The case of a 69-year-old patient revealed a rare complication called a synovial cutaneous fistula, which was diagnosed using a computed tomography arthrogram, highlighting its usefulness in both diagnosis and surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synovial cutaneous fistula complicating a reverse total shoulder arthroplasty. Letter, HP., Limback, J., Wasyliw, C., et al.[2023]

The use of an 'L' shaped frozen allograft for glenoid reconstruction during primary reverse shoulder arthroplasty effectively addressed severe bone loss, showing successful graft incorporation at 1-year follow-up without resorption.

The patient experienced significant pain relief and improved shoulder function, indicating that this one-step procedure can be a viable option for patients with massive glenoid bone loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reverse shoulder arthroplasty using a "L" shaped allograft for glenoid reconstruction in a patient with massive glenoid bone loss: case report. De Biase, CF., Ziveri, G., De Caro, F., et al.[2016]

References

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

Conjoint tendon release for persistent anterior shoulder pain following reverse total shoulder arthroplasty. [2022]

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

A method for documenting the change in center of rotation with reverse total shoulder arthroplasty and its application to a consecutive series of 68 shoulders having reconstruction with one of two different reverse prostheses. [2016]

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

Anatomic versus reverse shoulder arthroplasty: a mid-term follow-up comparison. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

Patient reported activities after reverse total shoulder arthroplasty in rotator cuff arthropathy patients. [2018]

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

Revision of failed hemiarthroplasty and anatomic total shoulder arthroplasty to reverse total shoulder arthroplasty. [2019]

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

Complications of rotator cuff repair. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Predictive factors of scapular notching in patients with reverse shoulder arthroplasty. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

[Revision surgery in reverse shoulder arthroplasty : Management of the most common complications]. [2023]

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

Risk of insufficient internal rotation after bilateral reverse shoulder arthroplasty: clinical and patient-reported outcome in 57 patients. [2022]

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

Reverse total shoulder arthroplasty with combined deltoid reconstruction in patients with anterior and/or middle deltoid tears. [2018]

11. France pubmed.ncbi.nlm.nih.gov

Review and clinical presentation in reverse shoulder arthroplasty in deltoid palsy. [2018]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Synovial cutaneous fistula complicating a reverse total shoulder arthroplasty. [2023]

13. Italy pubmed.ncbi.nlm.nih.gov

Reverse shoulder arthroplasty using a "L" shaped allograft for glenoid reconstruction in a patient with massive glenoid bone loss: case report. [2016]