RC Repair Versus Subacromial Balloon Spacer in Older Adults

NCT05788250 | Not Yet Recruiting

• 1 other identifier: RCBAL-01-2023
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rotator Cuff Tears

Keywords

rotator cuff repair; subacromial spacer; older adults

Outcome Measures

Primary Outcomes (3)

• Study feasibility - randomized

  Percentage of patients randomized

  1 year

• Study feasibility - recruitment

  Number of screened patients and proportion that are deemed eligible that consent

  1 year

• Study feasibility - surgery

  Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.

  1 year

Secondary Outcomes (30)

• ASES Score

  Baseline, pre-operative

• ASES Score

  3 Months, post-operative

• ASES Score

  6 Months, post-operative

• ASES Score

  12 Months, post-operative

• ASES Score

  24 Months, post-operative

Study Arms (2)

Subacromial spacer implantation

EXPERIMENTAL

Procedure: Subacromial spacer implantation

Rotator Cuff Repair

ACTIVE COMPARATOR

Procedure: Rotator cuff repair

Interventions

Subacromial spacer implantation PROCEDURE

A biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.

Subacromial spacer implantation

Rotator cuff repair PROCEDURE

Rotator cuff repair with tenotomy of long head of biceps.

Rotator Cuff Repair

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• tendon is NOT amenable to partial or complete repair

Sponsors & Collaborators

• Panam Clinic: lead
• University of Manitoba: collaborator

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Jarret Woodmass, MD

  Pan Am Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila McRae, PhD

CONTACT

204-925-7469; smcrae@panamclinic.com

Brenna Cyr, BKin

CONTACT

204-927-2828; bcyr@panamclinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to their group allocation. This is possible because the incision and rehabilitation processes are consistent between groups. It is not possible for the treating surgeon to be blinded to group allocation, therefore a research team member (athletic or physical therapist) will remain blinded to group allocation and conduct all study related assessments as well as administer the patient-reported questionnaires. This will be maintained by the participant not removing their shirt during the study assessment. Patients will not be informed of which procedure they will undergo until the study is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: March 28, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 2, 2024

Record last verified: 2024-04