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Navigated implantation of cruciate ligament versus knee replacements

Navigated implantation of cruciate ligament versus knee replacements

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00021483
Enrollment
138
Registered
2020-07-28
Start date
2020-06-24
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

M17.9

Interventions

Group 1: Patients who have been treated with the BCS implant after a total knee prosthesis implantation with the "NAVIO surgical system". During consultation hours or on the admission day for the surg

Sponsors

Medizinische Hochschule Hannover
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Indication for total knee endoprosthesis for gonarthrosis - Indication for knee-sledge prosthesis for medial gonarthrosis - Intact cruciate ligaments - UCLA Activity Score 5 or higher - Age from 18 years

Exclusion criteria

Exclusion criteria: - BMI > 35 - Isolated lateral gonarthrosis - whole leg axis of >2° valgus - Flexion contracture of >5° and flexion deficit of <130 - Past cruciate ligament rupture - History of knee infections

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the comparison of the preoperative Forgotten Joint Score with the value after 5 years between the "XR" and the "BCS" group, the control group is the "sled prosthesis" group.

Secondary

MeasureTime frame
The most important secondary endpoint is the stability of the knee joint measured by gait analysis. Other secondary endpoints are the revision rate, Knee Society Score, Oxford Knee Score and WOMAC Score. Based on a separately prepared case number planning regarding the secondary endpoint of the gait analysis, the analysis is performed with 12 patients per group. The first 12 patients of each group are examined using the gait analysis.

Countries

Germany

Contacts

Public ContactYvonne Noll

Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift, Leitung Klinisches Studienmanagement

yvonne.noll@diakovere.de0511-5354-649

Outcome results

None listed

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