N/A
N=20
The Metaphyseal Hip Prosthesis - Total Hip
Osteoarthritis of the Hip
Bottom Line
View on ClinicalTrials.gov: NCT01501955 ↗Enrolled (actual)
20
Serious AEs
45.0%
Results posted
Aug 2018
Primary outcome: Primary: RSA Translation X — 0.05; 0.05; 0.10; 0.08 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Metaphyseal Hip Prosthesis (Device); Stanmore (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY RSA Translation X |
0.05; 0.05; 0.10; 0.08; 0.13; 0.08 | — |
| PRIMARY RSA Translation Y |
-0.25; -0.18; -0.47; -0.31; -0.54; -0.25 | — |
| PRIMARY RSA Translation Z |
-0.10; -0.08; -0.23; -0.02; -0.19; -0.19 | — |
| PRIMARY RSA Rotation X |
-0.22; -0.18; -0.18; -0.23; -0.27; -0.44 | — |
| PRIMARY RSA Rotation Y |
0.57; 0.65; 1.13; 1.22; 1.43; 0.52 | — |
| PRIMARY RSA Rotation Z |
-0.05; -0.26; -0.01; -0.35; -0.11; -0.71 | — |
| PRIMARY RSA MTMP |
1.44; 0.81; 1.75; 1.34; 1.76; 1.31 | — |
| SECONDARY Number of Reported Device Related Complications |
1; 4 | — |
| SECONDARY Harris Hip Score |
50.5; 64.0; 90.5; 83.8; 91.3; 83.8 | — |
| SECONDARY DEXA |
10.8; 6.8; -4.8; -8.1; -8.1; -17.7 | — |
| SECONDARY HOOS-Pain Subscale |
44.4; 51.7; 84.2; 74.7; 78.6; 76.1 | — |
| SECONDARY HOOS-Symptom Subscale |
39.5; 57.2; 74.4; 63.1; 68.8; 70.7 | — |
| SECONDARY HOOS-ADL Subscale |
46.6; 52.4; 76.4; 77.77; 81.4; 78.0 | — |
| SECONDARY HOOS-Sport Subscale |
27.3; 26.6; 56.3; 40.3; 59.4; 50.0 | — |
| SECONDARY HOOS-QoL Subscale |
34.8; 34.5; 60.2; 60.1; 59.4; 62.5 | — |
| SECONDARY SF-12 Physical Summary Score |
34.7; 37.3; 44.2; 41.3; 42.4; 43.0 | — |
| SECONDARY SF-12 Mental Summary Score |
53.7; 53.5; 56.9; 50.8; 59.7; 53.1 | — |
Summary
The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.
Eligibility Criteria
Inclusion Criteria
- Candidates for a total hip replacement because of arthritis of the hip
- Patients with a good general condition
- Patients willing and able to participate in the clinical trial with a 10 years follow up and who have signed an inform consent
- Males and females
- Age between 55 and 75
- Absence or little presence of osteoporotic bone (t>-2)
- ASA score 1 and 2
Exclusion Criteria
- Patient with co morbidities that limit the physical abilities which may negatively influence the scores. Such co morbidities can for example be cardiac insufficiency or chronic respiratory diseases.
- Severe systematic diseases such as rheumatic arthritis and SLE.
- General osteoporosis (t 2.
Data sourced from ClinicalTrials.gov (NCT01501955). 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.