N/A
N=180
A Study on M2a Magnum Total Hip Arthroplasty
Degenerative Joint Disease · Avascular Necrosis
Bottom Line
View on ClinicalTrials.gov: NCT01010763 ↗Enrolled (actual)
180
Serious AEs
1.1%
Results posted
Jun 2019
Primary outcome: Primary: Range of Motion — 109.2; 110.2 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Total Hip Arthroplasty (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Range of Motion |
109.2; 110.2 | — |
| SECONDARY Metal Ion |
1.07; 3.8 | — |
| SECONDARY UCLA Activity Score |
4.97; 4.8 | — |
| SECONDARY Radiographic Assessment |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Harris Hip Score |
96.3; 94.5 | — |
| SECONDARY Metal Ion |
1.07; 3.8 | — |
| SECONDARY Metal Ion |
1.07; 3.8 | — |
| SECONDARY Metal Ion |
1.07; 3.8 | — |
| SECONDARY Metal Ion |
1.07; 3.8 | — |
| SECONDARY Metal Ion |
1.07; 3.8 | — |
| SECONDARY Metal Ion |
1.07; 3.8 | — |
Summary
The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty.
Eligibility Criteria
Inclusion Criteria
- Patients suitable for primary Total Hip Replacement
- Patients aged over 20
- Patients with limited co-morbidity- ASA I-III
- Patients must be able to understand instructions and be willing to return for follow-up
- Patients willing to provide blood and urine samples for metal ion analysis at follow-up
Exclusion Criteria
- Pre-existing metal implants
- Infection, sepsis, and osteomyelitis
- Uncooperative patient or pt with neurologic disorders who are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- osteomalacia
- distant foci of infections which may spread to the implant site
- rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- vascular insufficiency, muscular atrophy, or neuromuscular disease
- pregnancy
Data sourced from ClinicalTrials.gov (NCT01010763). 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.