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NCT01048710
Treatment of Medial Compartmental Osteoarthritis Grade 1-4 With TomoFix™ Small or Conservatively
trial testing No intervention in Osteoarthritis, Knee in 148 participants. Completed in 7 May 2018.
31 March 2015
Quick facts
| Lead sponsor | Synthes GmbH |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 148 |
| Start date | 1 July 2009 |
| Primary completion | 31 March 2015 |
| Estimated completion | 7 May 2018 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- No intervention
Conditions studied
- Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
- Osteonecrosis — all drugs for Osteonecrosis →
Sponsor
Synthes GmbH
Who can join
40 and older, any sex, with Osteoarthritis, Knee or Osteonecrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this prospective multicenter study is to assess whether the functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental osteoarthritis and osteonecrosis of the knee treated with open wedge high tibial osteotomy (HTO) using the TomoFix™ Small is better than the functional outcome after conservative treatment.
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 NCT01048710
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Osteoarthritis, Knee
Currently open trials in the same condition.
- NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
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- NCT07386561 — Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty · NA · active not recruiting
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Other Synthes GmbH trials
Trials by the same sponsor.
- NCT03635320 — The CHINA TFNA Study · NA · completed
- NCT02203448 — Facet Wedge Post Market Study · completed
- NCT02056834 — chronOS Inject in Proximal Tibial Fractures · completed
- NCT01847898 — Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting · Phase 4 · completed
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 NCT01048710 (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 Synthes GmbH
- Last refreshed: 22 August 2018
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/NCT01048710.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing