RC Repair Versus Subacromial Balloon Spacer in Older Adults

Not Applicable

Not yet recruiting

• Conditions: Rotator Cuff Tears
• Interventions: Procedure: Rotator cuff repair; Procedure: Subacromial spacer implantation

• Registration Number: NCT05788250
• Lead Sponsor: Panam Clinic

Brief 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).

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Study Start: 2024-08
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotator Cuff Repair	Rotator cuff repair	-
Subacromial spacer implantation	Subacromial spacer implantation	-

Primary Outcome Measures

Name	Time	Method
Study feasibility - surgery	1 year	Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.
Study feasibility - recruitment	1 year	Number of screened patients and proportion that are deemed eligible that consent
Study feasibility - randomized	1 year	Percentage of patients randomized

Secondary Outcome Measures

Name	Time	Method
EQ5D-3L	24 Months, post-operative	The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011). A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population. There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive. The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
SANE Score	24 Months, post-operative	The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019). Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Constant Score	24 Months, post-operative	The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Isometric Strength	24 Months, post-operative	Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
ASES Score	24 Months, post-operative	The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America
Range of Motion	24 Months, post-oeprative	For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.