Skip to content

A Prospective Non-Randomized Controlled Study to Evaluate the Efficacy and Safety of Subacromial Balloon Spacer in the Treatment of Massive Irreparable Rotator Cuff Tears

Clinical Application of the Subacromial Balloon Spacer Technique in Managing Massive Irreparable Rotator Cuff Tears - Subacromial Balloon Technique for Massive Irreparable Rotator Cuff Tears

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104173
Enrollment
Unknown
Registered
2025-06-12
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Massive Irreparable Rotator Cuff Tears

Interventions

Intervention Group:Arthroscopic partial rotator cuff repair followed by implantation of a biodegradable subacromial balloon spacer to restore shoulder biomechanics and function.
Control Group:Reconstruction of the Superior Joint Capsule Using Autogenous Long Head of Biceps Tendon

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age range: 50 years and above. 2. Imaging examination (e.g., MRI) confirms the presence of a large, irreparable rotator cuff tear, and the patient meets the indications for surgical treatment. 3. The patient meets the indications for subacromial balloon implantation, meaning the shoulder joint requires functional restoration through non-traditional repair methods, as traditional surgical methods have failed to repair the rotator cuff tear. 4. The shoulder joint has a certain degree of anterior-posterior balance, making it suitable for balloon implantation. 5. Preoperative shoulder joint functional scores are low, with significant limitation in shoulder range of motion, meeting the functional improvement goals of the study. 6. The patient or their guardian has signed an informed consent form and is willing to participate in the clinical study.

Exclusion criteria

Exclusion criteria: 1. Patients with severe shoulder osteoarthritis, deformity, or other conditions that compromise the restoration of normal shoulder biomechanics. 2. Presence of other serious intra-articular shoulder pathologies, such as tumors or severe infections, which may affect surgical safety and recovery. 3. Patients with severe systemic diseases, such as advanced cardiac disease, hepatic or renal insufficiency, that contraindicate surgery or anesthesia. 4. History of severe allergies, bleeding disorders, or other medical conditions that conflict with surgical intervention. 5. Patients who, due to living conditions or health status, are unable to comply with at least 12 months of follow-up and assessment.

Design outcomes

Primary

MeasureTime frame
operation effect;

Secondary

MeasureTime frame
Constant Shoulder Score;Visual Analogue Scale (VAS) for Pain;UCLA Shoulder Score;Postoperative complications;

Countries

China

Contacts

Public ContactXin Tang

West China Hospital, Sichuan University

tangxin9388@163.com+86 189 8060 6327

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026