Trials / Active Not Recruiting
Active Not RecruitingNCT02851992
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 303 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.
Detailed description
The objective of this prospective clinical study is to obtain multi-center, long-term (10-year) clinical data on the new GTS® femoral stem in its standard and lateralized versions as part of Post Market Surveillance requirements. The initial study assessment period will be 12 years; 24 months recruitment and the follow-up clinical reviews for all patients will be at 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GTS cementless stem | Total Hip Arthroplasty |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2020-12-01
- Completion
- 2028-09-01
- First posted
- 2016-08-02
- Last updated
- 2023-12-01
- Results posted
- 2023-12-01
Source: ClinicalTrials.gov record NCT02851992. Inclusion in this directory is not an endorsement.