Implant-free loop tenodesis compared to arthroscopic anchor tenodesis for treatment of the long head of biceps: a multi-center non-inferiority randomized controlled trial

Not Applicable

• Conditions: S46.1; M75.2; Injury of muscle and tendon of long head of biceps; Bicipital tendinitis

• Registration Number: DRKS00034361
• Lead Sponsor: niversitätsklinikum Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Written informed consent

At least one of the following:
- partial or subtotal tears of the LHB tendon,
- chronic LHB inflammation,
- LHB instability (pulley lesions)
- traumatic or degenerative SLAP lesions

Exclusion Criteria

- osteoarthritis of the affected or contralateral shoulder
- shoulder stiffness,
- chronic glenohumeral instability
- (previous) distal biceps tendon lesions
- previous surgery on the contralateral shoulder
- concomitant fracture of the shoulders/arms
- concomitant neurovascular injury of the affected shoulder/arm
- intake of oral corticosteroids
- age under 18 years or other reasons for lacking capability to consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HB score after 12 months following surgical intervention

Secondary Outcome Measures

Name	Time	Method
Intra- and postoperative complications during 24 postoperative months;<br>LHB score after 6 weeks, 6 months, and 24 months following surgical intervention; <br>Constant score, DASH score, ASES score, SF-36 score after 6 weeks, 6 months, 12 months and 24 months; <br>elbow flexion strength and supination strength after 6 months, 12 months and 24 months;<br>LHB location in ultrasound evaluation after 6 weeks, 6 months, 12 months and 24 months;<br>LHB location in MRI scan after 24 months