Evaluation of the Safety and Efficiency of the Metaphyseal Hip Prosthesis - Total Hip Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis of the Hip
- Sponsor
- Zimmer Biomet
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- RSA Translation Z
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
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 (Dual Energy X-Ray Absorptiometry (bone scan test)) 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.
Investigators
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).
- •Hormonal conditions such as Paget disease, which reduces the bone density.
- •Diseases that can negatively influence the 10 years life expectancy.
- •Chronic use of corticosteroids.
- •Extreme overweight defined as BMI above
- •Active bacterial infection.
- •Mental weakness which could negatively influence the postoperative recovery and influence the ability to complete pain scores and other questionnaires.
- •ASA score \>2.
Outcomes
Primary Outcomes
RSA Translation Z
Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively
Stem movement along z-axis in mm (measured with RSA)
RSA MTMP
Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively
Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.
RSA Translation X
Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively
Stem movement measured with RSA (radiostereometric analysis) along the x-axis in mm. RSA is a technique to accurately measure 3D movement of the prosthesis in the bone. The movement is measured with respect to the situation directly postoperative.
RSA Translation Y
Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively
Stem movement along the y-axis in mm. (measured with RSA)
RSA Rotation X
Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively
Stem Rotation around X-axis in degrees (measured with RSA)
RSA Rotation Y
Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively
Stem rotation around the y-axis in degrees ( measured with RSA)
RSA Rotation Z
Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively
Stem rotation around the z-axis in degrees (measured with RSA)
Secondary Outcomes
- Number of Reported Device Related Complications(6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperatively)
- Harris Hip Score(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- DEXA(1 and 2 years postoperative)
- HOOS-Pain Subscale(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- HOOS-Symptom Subscale(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- HOOS-ADL Subscale(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- HOOS-Sport Subscale(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- HOOS-QoL Subscale(pre-operatively, 6 weeks, 3 months, 6 months, 1,2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- SF-12 Physical Summary Score(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)
- SF-12 Mental Summary Score(pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively)