RC Repair Versus Subacromial Balloon Spacer in Older Adults

Panam Clinic

Status: Not yet enrolling

Conditions: Rotator Cuff Tears

Treatments: Procedure: Subacromial spacer implantation; Procedure: Rotator cuff repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05788250

RCBAL-01-2023

Details and patient eligibility

About

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

Full 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).

Enrollment: 32 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 70 years of age or older
• clinical and radiological diagnosis of a full thickness supraspinatus (or larger) RC tear >2cm or more than 1 full tendon
• ongoing symptoms after 3 months of physiotherapy
• a tendon amenable to partial or complete repair (as determined by pre-operative MRI)
• absence glenohumeral arthritis (Hamada < 3)
• absence of neoplastic diseases at treated site

Exclusion criteria

• previous surgery or pseudoparalysis on study shoulder
• complete subscapularis deficiency
• external rotation lag signs
• avascular necrosis
• post-infectious arthritis
• proximal humerus fracture
• inflammatory arithritis
• axillary nerve palsy
• concomitant tendon transfer
• neuromuscular disorder
• unable to speak/read English

Intra-operative Exclusion:

-tendon is NOT amenable to partial or complete repair

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Subacromial spacer implantation

Experimental group

Treatment:

Procedure: Subacromial spacer implantation

Rotator Cuff Repair

Active Comparator group

Treatment:

Procedure: Rotator cuff repair