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A prospective, single-center, randomized controlled study on shoulder joint function and retear rate after full-thickness rotator cuff injury treatment using knotless hot air balloon technique and traditional knotted suture bridge technique

A prospective, single-center, randomized controlled study on shoulder joint function and retear rate after full-thickness rotator cuff injury treatment using knotless hot air balloon technique and traditional knotted suture bridge technique

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115254
Enrollment
Unknown
Registered
2025-12-24
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Rotator cuff injury

Interventions

Group A:Knotless hot air balloon double-row technology
Group B:The traditional knotted line bridge technology

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 50 and 80; (2) Patients with full-thickness rotator cuff tears who have not responded well to non-surgical treatment for 6 months; (3) Intraoperative arthroscopic measurement of the tear opening was smaller than 5cm (DeOrio and Cofield small-large tears); (4) Rotator cuff fat infiltration does not exceed Goutallier grade 2; (5) The first arthroscopic rotator cuff repair surgery was performed.

Exclusion criteria

Exclusion criteria: (1) Those with shoulder joint dislocation; (2) Combined with changes such as shoulder joint infection and glenohumeral osteoarthritis; (3) Intellectual disability or other reasons limit the patient's ability to act, making it impossible for them to sign the informed consent form; (4) Those with combined subscapular muscle injury.

Design outcomes

Primary

MeasureTime frame
The American Association of Shoulder and Elbow Surgeons Shoulder Function Scoring System (ASES) one year after the operation;The re-tear rate of the rotator cuff was evaluated by MRI of the affected shoulder one year after the operation;University of California Shoulder Joint Score (UCLA);Constant scores for shoulder joint function satisfaction;

Secondary

MeasureTime frame
Shoulder joint range of motion (ROM);Pain Function Score (VAS) score;Doppler ultrasound was used to evaluate the blood perfusion and healing of the rotator cuff tendon after repair;

Countries

China

Contacts

Public ContactGuo Jiang

Peking University Shenzhen Hospital

15908464720@163.com+86 136 0306 7246

Outcome results

None listed

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