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NCT04436211
Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA
trial testing Total Knee Arthroplasty in Osteo Arthritis Knee in 100 participants. Status unknown.
15 February 2021
Quick facts
| Lead sponsor | Medical University of Graz |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 15 February 2020 |
| Primary completion | 15 February 2021 |
| Estimated completion | 30 March 2022 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Total Knee Arthroplasty — full drug profile →
Conditions studied
- Osteo Arthritis Knee — all drugs for Osteo Arthritis Knee →
Sponsor
Medical University of Graz
Who can join
50 and older, any sex, with Osteo Arthritis Knee. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A promising new approach in total knee arthroplasty (TKA) for severe osteoarthritis of the knee joint is the the kinematic aligned procedure (KA). This technique provides prosthesis-positioning based on natural and individual axes of movement. Although first series have shown satisfying results, further verification by prospective studies and final meta-analyses will be required. Thus, the kinematic alignment represents one of the few new developments in TKA. Provided that patients are willing to participate in the study, patients data are collected preoperatively and during routine follow-up examinations and evaluated prospectively. Patients will receive either a conventionally mechanical aligned arthroplasty or a kinematical aligned TKA, according to a randomized procedure. The kinematic alignment will be achieved by the use of custom-made cutting-blocks. Therefore, the patients will undergo a computed tomography of the whole leg on the affected side. This is mandatory in order to provide the individually produced cutting blocks. In order to ensure comparability, patients are stratified regarding their age and gender before inclusion. Outcome will be measured by the use of standard scoring systems regarding function, pain and ROM (range of motion) three, six and 12 months after surgery. This study is a monocentric, prospective, randomized and controlled open study.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Unrestricted kinematic alignment offers limited functional benefit over mechanical alignment in medial pivot total knee arthroplasty: A randomized controlled trial using conventional instrumentation.
Koutp A, Schroedter R, Leitner L, Vielgut I, et al · · 2026 · cited 3× · PMID 40679259 · DOI 10.1002/ksa.12751 -
Posterior condylar offset and clinical outcomes in medial pivot total knee arthroplasty: A comparison of mechanical and kinematic alignment.
Koutp A, Huetter K, Schroedter R, Leitner L, et al · · 2026 · PMID 41783686 · DOI 10.1002/jeo2.70679
Verify or expand the search:
- PubMed search for NCT04436211
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06627699 — Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® · not yet recruiting
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Other recruiting trials for Osteo Arthritis Knee
Currently open trials in the same condition.
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- NCT06485843 — An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Jo · Phase 2 · recruiting
- NCT06965946 — Intermittent Hypoxia-Hyperoxia Combined With Physical Therapy for Knee Osteoarthritis · NA · recruiting
- NCT06058169 — Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2) · NA · recruiting
Other Medical University of Graz trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04436211 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Graz
- Last refreshed: 17 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04436211.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing