NCT05788250

RC Repair Versus Subacromial Balloon Spacer in Older Adults

Randomized Clinical Trial Comparing Rotator Cuff Repair (RCR) With Subacromial Balloon Spacer (SBS) Implantation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Panam Clinic · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to assess the feasibility of a full randomized trial design.

Detailed description

The feasibility objectives are: 1. Recruitment 1. To establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent. 2. To establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears. 2. Surgery -to confirm agreement among surgeons regarding the protocol's standardized surgical techniques of both groups. Clinical objectives for observational purposes only are as follows: 1. Patient reported and clinical outcomes. 2. Number of "failures" in each group (defined as additional surgery and/or having \<12% improvement in SANE score from baseline).

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
PROCEDURE	Subacromial spacer implantation	A biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.
PROCEDURE	Rotator cuff repair	Rotator cuff repair with tenotomy of long head of biceps.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2023-03-28
• Last updated: 2024-04-02