N/A
Completed N=120
Restoration® Modular Revision Hip System Post Market Study
Arthroplasty, Replacement, Hip
Source: ClinicalTrials.gov NCT00962013 ↗
Enrolled (actual)
120
Serious AEs
36.7%
Results posted
Aug 2014
Primary outcomePrimary: Stem Survivorship (%) — 94.64 stem survivorship percentage at 5 years — p=0.0136
Summary
The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stem Survivorship (%) |
94.64 | 0.0136 sig |
| PRIMARY Femoral Stem Fracture |
— | — |
| SECONDARY Radiographic Stability |
97.6 | — |
| SECONDARY Harris Hip Score |
46.33; 88.27 | <0.0001 sig |
| SECONDARY SF-36 Health Status Survey: Role - Physical |
31.21; 42.25; 44.66 | <0.0001 sig |
| SECONDARY Post-surgery Femoral Crack/Fracture and Subsidence Rate |
1.64; 1.64 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Candidates for cementless revision of a failed femoral prosthesis.
- Patients willing to sign the informed consent.
- Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.
- Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.
Exclusion Criteria
- Patients with ongoing infection.
- Patients who are severely immunocompromised.
- Patients who are prisoners.
Data sourced from ClinicalTrials.gov (NCT00962013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.