Trials / Terminated
TerminatedNCT01883492
A Prospective Multi-center Study on Total Hip Arthroplasty With E1
A Prospective Multi-center Randomized Study on Total Hip Replacement With E1
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- Female
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this clinical study include: * Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1 * Compare E1 wear used with CoCr and Biolox Delta heads
Detailed description
This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement. Patient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases. Randomization will occur via random number generator by 4 blocks randomization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Femoral Stem | JMDN classification/Class III device |
| DEVICE | Acetabular Cup | JMDN classification: Class III device |
| DEVICE | Acetabular Liner | JMDN classification: Class III device |
Timeline
- Start date
- 2013-03-11
- Primary completion
- 2019-02-06
- Completion
- 2019-03-15
- First posted
- 2013-06-21
- Last updated
- 2020-02-17
- Results posted
- 2020-02-17
Locations
5 sites across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01883492. Inclusion in this directory is not an endorsement.