Skip to content

Evaluation of the stabilizing effect and fit of a semi-flexible, individually adjustable four-point knee brace in patients after anterior cruciate ligament reconstruction

Evaluation of the stabilizing effect and fit of a semi-flexible, individually adjustable four-point knee brace in patients after anterior cruciate ligament reconstruction - Stabilizing effect and fit of a four-point brace after ACL reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040326
Enrollment
38
Registered
2026-05-21
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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: After recruitment and informed consent, participants will be randomly assigned to an orthosis group and are expected to wear the orthosis until the completion of both measurement sessions. Th

Sponsors

Experimentelle Orthopädie, Universitätsklinikum Jena, Campus Eisenberg, Waldkliniken Eisenberg, Friedrich-Schiller-Universität Jena, Jena, Deutschland Englisch: Experimental Orthopaedics, University Hospital Jena, Campus Eisenberg, Waldkliniken Eisenberg, Friedrich-Schiller-Universität Jena
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: • ACL rupture with indication for surgical treatment • Age between 18 and 60 years • Physically active individuals participating in occasional sports activities, defined as Tegner Activity Scale =3 • Healthy contralateral limb* • Patients who receive the same postoperative treatment protocol due to comparable severity and type of injury and surgical procedure * The contralateral limb is considered healthy if the non-operated lower extremity has had no acute injury, no surgery, no relevant pain, and no musculoskeletal or neurological complaints within the previous six months that could affect gait or the performance of the measurement tasks.

Exclusion criteria

Exclusion criteria: • Injury of the posterior cruciate ligament • Medial knee instability > grade I according to Hughston • Neurological disorders or other comorbidities that may affect gait

Design outcomes

Primary

MeasureTime frame
Knee joint kinematics (sagittal, frontal, and transverse rotation; anteroposterior and mediolateral translation) during gait, recorded using a 3D camera system 1–4 days preoperatively and 21–28 days postoperatively.

Secondary

MeasureTime frame
Knee joint moments in the sagittal and frontal during walking and turning; Ground reaction forces during gait and turning; Gait symmetry score; Muscle activity of the biceps femoris, the medial hamstrings or semitendinosus/semimembranosus muscles, as well as the vastus medialis, vastus lateralis, and rectus femoris muscles during walking and turning; Positional stability of the ortheses during walking Wearing comfort and perveiced stability

Countries

Germany

Contacts

Public ContactStanislaw Siegel

Experimentelle Orthopädie, Universitätsklinikum Jena, Campus Eisenberg, Waldkliniken Eisenberg, Friedrich-Schiller-Universität Jena, Jena, Deutschland

s.siegel@waldkliniken-eisenberg.de03669181088

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026