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NCT00546598
Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System
Phase 4 trial testing Total hip replacement/arthroplasty in Non-inflammatory Joint Disease in 106 participants. Terminated before completion.
1 April 2014
Quick facts
| Lead sponsor | DePuy Orthopaedics |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 106 |
| Start date | 1 January 2006 |
| Primary completion | 1 April 2014 |
| Estimated completion | 1 April 2014 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Total hip replacement/arthroplasty
Conditions studied
- Non-inflammatory Joint Disease — all drugs for Non-inflammatory Joint Disease →
- Osteoarthritis — all drugs for Osteoarthritis →
- Avascular Necrosis — all drugs for Avascular Necrosis →
- Congenital Hip Dysplasia — all drugs for Congenital Hip Dysplasia →
Sponsor
DePuy Orthopaedics — full company profile →
Who can join
Adults 21 to 80, any sex, with Non-inflammatory Joint Disease or Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00546598
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other DePuy Orthopaedics trials
Trials by the same sponsor.
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- NCT05357664 — PINNACLE® DM RSA Study · NA · terminated
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- NCT04730271 — Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee A · NA · 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 NCT00546598 (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 DePuy Orthopaedics
- Last refreshed: 30 November 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/NCT00546598.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing