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LARS Combined with Fascia Lata Compared with Fascia Lata Alone in Massive Rotator Cuff Repair: A Clinical Outcomes Study

LARS Artificial Ligament Combined with Fascia Lata versus Fascia Lata Alone for Supraspinatus Tendon Reconstruction in Massive Rotator Cuff Tears: A Non-inferiority Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104268
Enrollment
Unknown
Registered
2025-06-13
Start date
2026-01-01
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

Irreparable massive rotator cuff tears

Interventions

Experimental group:LARS Artificial Ligament-Reinforced Fascia Lata graft for supraspinatus tendon reconstruction
Control group:autologous fascia lata graft for supraspinatus tendon reconstruction

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years, regardless of gender; 2.Massive rotator cuff tear detected by preoperative MRI (massive rotator cuff tear criteria: tear length in the anteroposterior direction on sagittal view =5 cm, or involving two or more rotator cuff tendons); 3.Intraoperative evaluation confirms irreparable massive rotator cuff tear; 4.Consent to undergo random arthroscopic reconstruction with LARS artificial ligament combined with autologous fascia lata or arthroscopic autologous fascia lata reconstruction alone.

Exclusion criteria

Exclusion criteria: 1.Severe anesthesia contraindications (ASA class III or above); 2.Presence of perineural injuries around the shoulder joint; 3.Preoperative imaging shows Hamada classification grade 4 or above: grade 4: grade 3 + glenohumeral joint space narrowing; grade 5: humeral head cartilage defect; 4.Presence of local and systemic infectious diseases of the shoulder joint.

Design outcomes

Primary

MeasureTime frame
The American Shoulder and Elbow Surgeons (ASES) score;

Secondary

MeasureTime frame
Surgical Parameters;University of California, Los Angeles (UCLA) shoulder score;Mean peak abduction torque;Range of Motion (ROM) Evaluation;Imaging Assessments;Constant-Murley shoulder functional score;Visual Analog Scale (VAS);Complication rate;

Countries

China

Contacts

Public ContactBinghua Zhou

The First Affiliated Hospital of Army Medical University

yijian510868@hotmail.com+86 23 68765797

Outcome results

None listed

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