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

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 - LOOPTEN

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034361

Enrollment

192

Registered

2024-06-12

Start date

2024-12-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

S46.1 M75.2

Interventions

Group 1: Arthroscopic implant-free loop tenodesis of the long head of biceps (experimental intervention group) Group 2: Arthroscopic epiosseous anchor tenodesis of the long head of biceps (standard-o

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
LHB score after 12 months following surgical intervention	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactMaximilian Kerschbaum

Universitätsklinikum Regensburg

maximilian.kerschbaum@ukr.de+49 941 9446805

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026