Clinical trial NCT05788250: RC Repair Versus Subacromial Balloon Spacer in Older Adults
Official title: Randomized Clinical Trial Comparing Rotator Cuff Repair (RCR) With Subacromial Balloon Spacer (SBS) Implantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: rotator cuff repair
subacromial spacer
older adults
Lead sponsor: Panam Clinic
Sponsor class: OTHER
Collaborators: name: University of Manitoba
First posted: 2023-03-28
Enrollment: 32
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This a double-blind (patient and assessor), parallel, 1:1 multicentre randomized pilot study comparing patients 70 years and older randomized to SBS or RCR. 32 participants from eight orthopaedic surgeons at four sites will be recruited over a one-year period. Randomization will be generated using a web-based system pre-operatively and stratified to ensure 8 medium/large tears and 8 massive tears are allocated to each group.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Study feasibility - randomized
timeFrame: 1 year
measure: Study feasibility - recruitment
timeFrame: 1 year
measure: Study feasibility - surgery
timeFrame: 1 year
Secondary outcomes:
measure: ASES Score
timeFrame: Baseline, pre-operative
measure: ASES Score
timeFrame: 3 Months, post-operative
measure: ASES Score
timeFrame: 6 Months, post-operative
measure: ASES Score
timeFrame: 12 Months, post-operative
measure: ASES Score
timeFrame: 24 Months, post-operative
measure: EQ5D-3L
timeFrame: Baseline, pre-operative
measure: EQ5D-3L
timeFrame: 3 Months, post-operative
measure: EQ5D-3L
timeFrame: 6 Months, post-operative
measure: EQ5D-3L
timeFrame: 12 Months, post-operative
measure: EQ5D-3L
timeFrame: 24 Months, post-operative
measure: SANE Score
timeFrame: Baseline, pre-operative
measure: SANE Score
timeFrame: 3 Months, post-operative
measure: SANE Score
timeFrame: 6 Months, post-operative
measure: SANE Score
timeFrame: 12 Months, post-operative
measure: SANE Score
timeFrame: 24 Months, post-operative
measure: Constant Score
timeFrame: Baseline, pre-operative
measure: Constant Score
timeFrame: 3 Months, post-operative
measure: Constant Score
timeFrame: 6 Months, post-operative
measure: Constant Score
timeFrame: 12 Months, post-operative
measure: Constant Score
timeFrame: 24 Months, post-operative
measure: Range of Motion
timeFrame: Baseline, pre-operative
measure: Range of Motion
timeFrame: 3 Months, post-oeprative
measure: Range of Motion
timeFrame: 6 Months, post-operative
measure: Range of Motion
timeFrame: 12 Months, post-operative
measure: Range of Motion
timeFrame: 24 Months, post-oeprative
measure: Isometric Strength
timeFrame: Baseline, pre-operative
measure: Isometric Strength
timeFrame: 3 Months, post-operative
measure: Isometric Strength
timeFrame: 6 Months, post-operative
measure: Isometric Strength
timeFrame: 12 Months, post-operative
measure: Isometric Strength
timeFrame: 24 Months, post-operative
Other outcomes:
Locations:
Study officials:
affiliation: Pan Am Clinic
name: Jarret Woodmass, MD
role: PRINCIPAL_INVESTIGATOR
References: