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NCT03450733
Wright Medical Technology Metal-on-Metal 522 Post-Market Surveillance Study
trial testing Wright Medical Technology Metal-on-Metal Total Hip System in Osteoarthritis, Hip in 173 participants. Completed in 18 June 2022.
24 November 2021
Quick facts
| Lead sponsor | MicroPort Orthopedics Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 173 |
| Start date | 11 April 2018 |
| Primary completion | 24 November 2021 |
| Estimated completion | 18 June 2022 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Wright Medical Technology Metal-on-Metal Total Hip System
Conditions studied
- Osteoarthritis, Hip — all drugs for Osteoarthritis, Hip →
- Hip Disease — all drugs for Hip Disease →
- Hip Osteoarthritis — all drugs for Hip Osteoarthritis →
- Joint Pain — all drugs for Joint Pain →
Sponsor
MicroPort Orthopedics Inc.
Who can join
21 and older, any sex, with Osteoarthritis, Hip or Hip Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is in response to the Food and Drug Administration (FDA) call to all manufacturers with 510(k) clearance for metal-on-metal (MoM) total hip arthroplasty (THA) devices to conduct postmarket surveillance studies. MicroPort has various acetabular shells, acetabular liners, fixation screws, femoral heads, femoral stems, modular necks, and proximal bodies currently cleared for MoM indications. Together these components comprise the Wright Medical Technology (WMT) MoM THA System. The primary objective of the study is to determine the incidence of adverse local tissue reactions (ALTR) in each THA implanted with the WMT MoM THA System overall and to create cross-sectional epochs of ≤ 8 years and \> 8 years, since implantation.
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 NCT03450733
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoarthritis, Hip
Currently open trials in the same condition.
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- NCT06342843 — Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH) · NA · recruiting
- NCT06249958 — Transforming Rehabilitation: Personalised Care for a Better Quality of Life · recruiting
- NCT05700682 — Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee · recruiting
Other MicroPort Orthopedics Inc. trials
Trials by the same sponsor.
- NCT07391592 — Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate · active not recruiting
- NCT04147559 — Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem · enrolling by invitation
- NCT04145401 — Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK · enrolling by invitation
- NCT03865667 — Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem · active not recruiting
- NCT02865447 — Evaluation of Bone Mineral Density Changes After Total Hip Replacement: A Two-Year Clinical and DXA Analysis · 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 NCT03450733 (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 MicroPort Orthopedics Inc.
- Last refreshed: 13 October 2022
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/NCT03450733.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing