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Dynamic intraligamentary stabilization versus primary tendinoplasty in acute lesion of the anterior cruciate ligament: a prospective randomized trial.

Dynamic intraligamentary stabilization versus primary tendinoplasty in acute lesion of the anterior cruciate ligament: a prospective randomized trial. - DIS vs. SEMIT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015466
Enrollment
40
Registered
2018-09-03
Start date
2014-05-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

S83.53

Interventions

Group 1: Dynamic intraligamentary stabilization using the Ligamys technique (ligament conserving) Group 2: Tendinoplasty using the ipsilateral semitendinosus tendon (ligament replacement)

Sponsors

Universitätsklinikum Münster, Klinik für Unfall-, Hand- und Wiederherstellungschirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: first time lesion of the anterior cruciate ligament; signed informed consent; willingness to participate in the follow up schedule; operation in the first 21 days after injury.

Exclusion criteria

Exclusion criteria: lack of compliance; lack of willingness to participate in the follow up schedule; dramatic, traumatic or degenerative lesions of meniscus or cartilage; earlier tendon graft harvesting in the injured leg; relevant medication; pregnancy.

Design outcomes

Primary

MeasureTime frame
Follow up one year postoperatively with assessment of subjective clinical scores (Tegner, Lysholm, IKDC subjective), visual analogue scale of pain and patient satisfaction, objective clinical assessment of range of motion, anterior translation (Rolimeter-Lachman) and pivot shift test, reoperation and complications.

Secondary

MeasureTime frame
In order to assess longterm results follow ups will be repeated after 2, 5 and 10 years including the assessment of subjective clinical scores (Tegner, Lysholm, IKDC subjective), visual analogue scale of pain and patient satisfaction, objective clinical assessment of range of motion, anterior translation (Rolimeter-Lachman) and pivot shift test, reoperation and complications. Optional assessment of MRI scans.

Countries

Germany

Contacts

Public ContactJohannes Glasbrenner

Universitätsklinikum Münster, Klinik für Unfall-, Hand- und Wiederherstellungschirurgie,

johannes.glasbrenner@ukmuenster.de02518356301

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 18, 2026