Trials / Active Not Recruiting
Active Not RecruitingNCT02316704
Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty
Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty: A Single-Blinded Randomized Controlled Trial Evaluating Implant Migration, Acetabular Liner Wear, and Patient Reported Outcome
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- Sponsor
- Hvidovre University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | THA with G7 PPS coted acetabular component | |
| DEVICE | THA with G7 OsseoTi coted acetabular component |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2017-02-01
- Completion
- 2027-04-01
- First posted
- 2014-12-15
- Last updated
- 2021-02-09
Locations
2 sites across 2 countries: Denmark, Sweden
Source: ClinicalTrials.gov record NCT02316704. Inclusion in this directory is not an endorsement.