Last reviewed · How we verify
NCT02949336: UKA
Kinematics Analysis of SIGMA® Partial Knee System
trial testing Observational use of fluoroscopy in Unicompartmental Knee Arthroplasty in 18 participants. Completed in 11 December 2017.
11 September 2017
Quick facts
| Lead sponsor | Stephen Ferguson |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 18 |
| Start date | 19 December 2016 |
| Primary completion | 11 September 2017 |
| Estimated completion | 11 December 2017 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Observational use of fluoroscopy
Conditions studied
- Unicompartmental Knee Arthroplasty — all drugs for Unicompartmental Knee Arthroplasty →
Sponsor
Stephen Ferguson
Who can join
18 and older, any sex, with Unicompartmental Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The proposed study is a prospective collection of health related personal data (observational study). A total of approximately 10 subjects with traditional medial SIGMA® High Performance Partial Knee System and 10 ACL deficient subjects with medial SIGMA® High Performance Partial Knee System are analyzed during sitting onto a chair and getting up, deep knee bend, stance and swing phase of level walking, downhill walking (ramp descent) and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. All the video-fluoroscopic testing is performed at the Institute for Biomechanics at the ETH Zurich. The UKA subjects are recruited based on the inclusion and exclusion criteria. The primary objective is to quantify and describe the three-dimensional kinematics for patients with a traditional medial SIGMA® High Performance Partial Knee System (functional ACL and tibial posterior slope matching the native bone) during these daily activities. The secondary objective is to evaluate patients with the same medial UKA implant (SIGMA® High Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted at a 50% reduced tibial posterior slope relative to the native knee.
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 NCT02949336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Unicompartmental Knee Arthroplasty
Currently open trials in the same condition.
- NCT05735847 — Surgery Induced Trauma After Total Versus Medial Unicompartmental Knee Arthroplasty (SITA) · active not recruiting
- NCT05876143 — Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants · recruiting
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 NCT02949336 (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 Stephen Ferguson
- Last refreshed: 23 January 2019
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/NCT02949336.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing