Conjoint Tendon Resection for Frozen Shoulder
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Missouri-Columbia
Disqualifiers: Revision RTSA, Acute fracture, others
No Placebo Group
Approved in 2 Jurisdictions
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?
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.16789
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.210111213
Research Team
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.
Trial 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 (Other)
Trial OverviewThe 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
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Missouri Orthopaedic InstituteColumbia, MO
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Who Is Running the Clinical Trial?
University of Missouri-Columbia
Lead Sponsor
Trials
387
Patients Recruited
629,000+
Findings from Research
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]
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]
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]
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]
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]
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]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Revision surgery in reverse shoulder arthroplasty : Management of the most common complications].Wittmann, T., Raiss, P.[2023]
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]
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]
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]
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]
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
Conjoint tendon release for persistent anterior shoulder pain following reverse total shoulder arthroplasty. [2022]
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]
Anatomic versus reverse shoulder arthroplasty: a mid-term follow-up comparison. [2022]
Patient reported activities after reverse total shoulder arthroplasty in rotator cuff arthropathy patients. [2018]
Revision of failed hemiarthroplasty and anatomic total shoulder arthroplasty to reverse total shoulder arthroplasty. [2019]
Complications of rotator cuff repair. [2022]
Predictive factors of scapular notching in patients with reverse shoulder arthroplasty. [2018]
[Revision surgery in reverse shoulder arthroplasty : Management of the most common complications]. [2023]
Risk of insufficient internal rotation after bilateral reverse shoulder arthroplasty: clinical and patient-reported outcome in 57 patients. [2022]
Reverse total shoulder arthroplasty with combined deltoid reconstruction in patients with anterior and/or middle deltoid tears. [2018]
Review and clinical presentation in reverse shoulder arthroplasty in deltoid palsy. [2018]
Synovial cutaneous fistula complicating a reverse total shoulder arthroplasty. [2023]
Reverse shoulder arthroplasty using a "L" shaped allograft for glenoid reconstruction in a patient with massive glenoid bone loss: case report. [2016]