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Anterior cruciate ligament reconstruction with autologous semitendinosus- or quadriceps tendon graft: Are there differences in objective and subjective patients' outcome? A randomized controlled trial.

Anterior cruciate ligament reconstruction with autologous semitendinosus- or quadriceps tendon graft: Are there differences in objective and subjective patients' outcome? A randomized controlled trial. - QuadSemiT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010246
Enrollment
60
Registered
2016-04-11
Start date
2016-09-01
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

Anterior Cruciate Ligament Rupture M23.51 S83.51

Interventions

Group 1: Primary anterior cruciate ligament reconstruction with autologous semitendinosus-tendon-graft (randomized) Group 2: Primary anterior cruciate ligament reconstruction with autologous quadricep

Sponsors

Universitätsklinikum Münster
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion criteria: - Primary rupture of anterior cruciate ligament (for randomization) - for the accessory controll group (study arm No 3, ACL Revision with Quadriceps tendon graft) a rerupture after primary ACL reconstruction/suture is inclusion criterion - Age 16-60 years - Signed informed consent, study and privacy agreements - Succesfully completed all standard preoperative procedures especially from anaesthesological und surgical point of view - Willing to participate on follow-up examinations. - Minor concomitant injuries such as small meniscus lesions (<1/3 partial meniscectomy or minor sutures), I-II° MCL instability, bone bruise without relevant chondral lesions or hemarthros are acceptable for inclusion.

Exclusion criteria

Exclusion criteria: - No compliance - Denial of participating in rehabilitation program - Severe traumatic or degenerative chondral or meniscal injuries - Multiligamental injuries/instability of higher grades (LCL, PCL or III° MCL) - Prior donation/extraction of tendon grafts at the same leg (except for the study arm No 3 / ACL Revision group if quadriceps tendon is still available) - Relevant co-medication or co-morbidities - Pregnancy

Design outcomes

Primary

MeasureTime frame
Instrumented Lachman Test side-by-side (delta in mm), measured by Rolimeter(R) determined after 12 months (3. FU). Further examination intervals: pre-/intraoperative, 1st FU 6 weeks (clin. scores and range of motion only), 2nd FU 3-6 months, 24 months, optional 5 and 10 years.

Secondary

MeasureTime frame
functional Scores (Lysholm, IKDC, Tegner, pain scale) evaluated with an iPad based "Heartbeat ONE" Device, "Back-in-Action" Analyses, Isokinetic msucle strength measurments, walking analyses, rang of motion, Pivot Shift Test; determined after 12 months. Further examination intervals: pre-/intraoperative, 1st FU 6 weeks (clin. scores and range of motion only), 2nd FU 3-6 months, 24 months, optional 5 and 10 years.

Countries

Germany

Contacts

Public ContactMirco Herbort

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

mirco.herbort@uni-muenster.de+492518356301

Outcome results

None listed

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