Trials / Terminated
TerminatedNCT04036279
NANOS Neck Preserving Hip Stem
A Prospective, Multicenter, Clinical Outcome Study of the NANOS Neck Preserving Stem in Patients With Degenerative Hip Joint Disease
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 130 (actual)
- Sponsor
- Smith & Nephew Orthopaedics AG · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to determine the long-term safety and effectiveness of the NANOS neck preserving stem in terms of radiographic and clinical performance as well as short-, mid- and long-term survivorship
Detailed description
The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the NANOS neck preserving hip stem. Effectiveness Measures: * Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, HOOS Score \[4-6\], UCLA Activity Rating \[7\] * Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration Safety evaluations: * Intra- and peri-operative device-related adverse events (AE) and complications up to discharge * Postoperative AE up to 10 years
Conditions
- Primary Osteoarthritis
- Secondary Osteoarthritis
- Dysplasia Osteoarthritis
- Avascular Femoral Neck Necrosis
- Post-Traumatic Femoral Neck Necrosis
- Intact Femoral Neck With Good Bone Quality
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Total Hip Arthroplasty |
Timeline
- Start date
- 2010-01-21
- Primary completion
- 2023-03-01
- Completion
- 2023-03-01
- First posted
- 2019-07-29
- Last updated
- 2023-06-07
Locations
3 sites across 3 countries: Germany, Netherlands, Poland
Source: ClinicalTrials.gov record NCT04036279. Inclusion in this directory is not an endorsement.