RC Repair Versus Subacromial Balloon Spacer in Older Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tuberoplasty Versus Balloon Spacer

NCT06735170

Rotator Cuff Tears

RECRUITING PHASE1/PHASE2

Surgical Management of Irreparable RC Tears

NCT03878862

Rotator Cuff Tear

RECRUITING

Comparison of Lateralized RTSA With and Without Subscapularis Repair

NCT04728282

Arthritis Shoulder

RECRUITING EARLY_PHASE1

Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation

NCT04975581

Rotator Cuff Tears

RECRUITING PHASE4

All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears

NCT00128076

Shoulder Pain Rotator Cuff Tear

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotator Cuff Tears

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subacromial spacer implantation

Group Type EXPERIMENTAL

Subacromial spacer implantation

Intervention Type PROCEDURE

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

Rotator Cuff Repair

Group Type ACTIVE_COMPARATOR

Rotator cuff repair

Intervention Type PROCEDURE

Rotator cuff repair with tenotomy of long head of biceps.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Subacromial spacer implantation

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

Intervention Type PROCEDURE

Rotator cuff repair

Rotator cuff repair with tenotomy of long head of biceps.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No