The Metaphyseal Hip Prosthesis - Total Hip
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01501955|
Recruitment Status : Terminated (First safety criterium not met.)
First Posted : December 30, 2011
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Hip||Device: Metaphyseal Hip Prosthesis Device: Stanmore||Not Applicable|
The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement at short term (1 year) and long term (10 years).
Bone remodeling will be analyzed at 10 years using DEXA measurements. This is a single-center prospective study with 25 patients in the study and 25 in the control group in open Randomized Clinical Trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Safety and Efficiency of the Metaphyseal Hip Prosthesis - Total Hip Arthroplasty|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||December 2023|
Active Comparator: Stanmore
25 patients will have the Stanmore prosthesis
Stanmore hip prosthesis
Other Name: Stanmore hip prosthesis
Experimental: Metaphyseal Hip Prosthesis
25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis
Device: Metaphyseal Hip Prosthesis
Metaphyseal Hip Prosthesis (MHP) hip replacement
Other Name: The Metaphyseal Hip Prosthesis
- Radiostereometric Analysis (RSA) [ Time Frame: 24 months postoperative ]The short term stability (stem position) of the Metaphyseal Hip Prosthesis (MHP) will be analysed using Radiostereometric Analysis (RSA) to predict the long term survival.
- Device related complications [ Time Frame: 10 years postoperative ]
- Frequency of serious device related complications.
- Harris Hip Score & Hip Osteoarthritis Outcome Score [ Time Frame: 10 years postoperative ]
Functional outcome measured with HHS and HOOS
- DEXA [ Time Frame: 10 years postoperative ]
Bone density measured using DEXA
- SF-12 [ Time Frame: 10 years postoperative ]
Quality of life measured with SF-12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501955
|Franciscus Ziekenhuis Roosendaal|
|Roosendaal, Netherlands, 4708|
|Principal Investigator:||C.A.M.P. Bell||Franciscus Ziekenhuis Roosendaal|