RC Repair Versus Subacromial Balloon Spacer in Older Adults

Sponsor
Panam Clinic
Study ID
NCT05788250
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Mar 28, 2023
Start date
Aug 31, 2024
Status verified
Apr 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Subacromial spacer implantation
  • Active Comparator: Rotator Cuff Repair

Primary Outcome Measure

Study feasibility - randomized [ Time Frame: 1 year ]

Central Contacts

Related Studies