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NCT04017533
Stability of Uncemented Medially Stabilized TKA
NA trial testing GMK Sphere TKR in Knee Osteoarthritis in 31 participants. Completed in 10 October 2024.
10 October 2024
Quick facts
| Lead sponsor | Oslo University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 31 |
| Start date | 4 September 2021 |
| Primary completion | 10 October 2024 |
| Estimated completion | 10 October 2024 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- GMK Sphere TKR
Conditions studied
- Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
Sponsor
Oslo University Hospital
Who can join
Adults 50 to 75, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patients' satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have been developed to solve the problem. The most common fixation mode is cemented TKR with good survival up to 15 years. However, newer series in younger patients also have shown lasting survival with uncemented implants (Nilsson et al 2006, Prudhon et al. 2017). Among various different designs, medially stabilized total knee, which are designed to reproduce natural knee kinematics with medial ball-in-socked design, is a promising implant (Australian registry report 2018). Dynamically the medial pivot knee performs more naturally (Bragnazoli et al, 2019) compared to other designs. Most data for this design is available only for the cemented version. Up to now there is no safety study performed that confirms the stability over time for this implant with uncemented fixation. In this study, we will therefore analyze the in vivo stability of an uncemented knee implant with medially stabilized design. Our study will contribute to the understanding of fixation and lead to safety to the patient.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04017533
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04017533 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oslo University Hospital
- Last refreshed: 25 November 2025
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/NCT04017533.
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