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NCT03201172
Univation® X Follow-Up Study
trial testing Primary Unicompartmental Knee Arthroplasty in Unicompartmental Knee Arthroplasty in 77 participants. Completed in 1 April 2020.
30 September 2019
Quick facts
| Lead sponsor | Aesculap AG |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 77 |
| Start date | 25 September 2017 |
| Primary completion | 30 September 2019 |
| Estimated completion | 1 April 2020 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Primary Unicompartmental Knee Arthroplasty
Conditions studied
- Unicompartmental Knee Arthroplasty — all drugs for Unicompartmental Knee Arthroplasty →
Sponsor
Aesculap AG — full company profile →
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 study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design. The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
No advantage for patient-specific UKA in comparison with standard UKA regarding clinical and functional results at short-term follow-up.
Haaker R, Moussa A, Sabev D. · · 2025 · cited 1× · PMID 40866508 · DOI 10.1007/s00590-025-04467-2
Verify or expand the search:
- PubMed search for NCT03201172
- 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
Other Aesculap AG trials
Trials by the same sponsor.
- NCT05441618 — Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant® · completed
- NCT05944081 — Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device · withdrawn
- NCT06298500 — Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair · completed
- NCT06055946 — Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatect · completed
- NCT05182320 — Study Measuring the Effects of Patient Data for Total Hip and Total Knee Arthroplasty Patients Using an APP Based Sensor · withdrawn
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 NCT03201172 (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 Aesculap AG
- Last refreshed: 15 April 2021
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/NCT03201172.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing