Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Younger hip patients often need revision of their hip replacement due to wear and loosening. Newer concepts (resurfacing and large head total hip replacement) with articulation surfaces in metal may reduce the wear, increase the longevity of the implant and give an improved function. The possible downside is that these concepts releases metal debris to the body. The investigators wish to see if the newer interventions are a clinical improvement compared to standard. The investigators also wish to investigate the extent of metal released to the body and any effect on the immune system. Finally the investigators wish to investigate the stability of these new implants and their ability to preserve the bone around the implant. The investigators hypothesis is: That the metal on metal articulations will not have better clinical outcomes than standard The resurfacing implant is expected to preserve the bone of the upper femoral bone. The implants are expected to be stabile within the first year.

Official Title
-----------------
Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Device: articular surface replacement ASR, DePuy
* Device: ReCap/Magnum modular head, Biomet
* Device: Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet
* Device: 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hip osteoarthritis Secondary osteoarthritis due to mild dysplasia Age from 40 to 65 years Exclusion Criteria: Dysplasia with CE angle < 25 degrees on the AP projection Severe femoral head deformation Reduced femoral neck length Leg length discrepancy more than 1 cm Need for restoration of offset Deformation after fractures or earlier osteotomies A previous hip arthroplasty Inflammatory arthritis Endocrinological disease with bone metabolic manifestations Renal disease Malignant disease Neuro/muscular or vascular diseases of the affected leg Osteoporosis Use of opioid pain killers due to other diseases High dose corticosteroids Obese with BMI > 35 Pregnant or planning to be Ppresented problems that would prevent completing our follow-up program

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: resurfacing<br>a hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint | Device: articular surface replacement ASR, DePuy<br>* posterolateral incision<br>|
| Experimental: large head THA<br>a standard stemmed THA but with a large metal head, and a metal-metal articulation | Device: ReCap/Magnum modular head, Biomet<br>* posterolateral incision<br>|
| Active Comparator: 28 mm ceramics-polyethylene<br>a standard 28 mm head uncemented THA | Device: Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet<br>* posterolateral incision<br>|
| Active Comparator: 28 mm metal-polyethylene THA<br>a standard stemmed uncemented THA | Device: 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)<br>* posterolateral incision<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion | range of motion in the hip joint evaluated by goniometer | Up to two months before surgery | 
| Range of motion | Range of motion of the hip joint | 8 weeks +/- 1 week | 
| Range of motion | range of motion in the hip joint | 6 months +/- 2 weeks | 
| Range of motion | range of motion in the hip joint | 1 year +/- 1 month | 
| range of motion | range of motion in the hip joint | 2 year +/- 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metal ions | Crome and cobalt ions in serum and whole blood. | Up to two months before surgery | 
| BMD | bone mass density around the implants | Within the first week following surgery | 
| RSA | radiostereommetry. Measurement of micromotions (subsidence, rotation and translations)of the implant in relation to the bone | Within the first week following surgery | 
| HHS | Harris hip score. An investigator asssesed hip questionnaire including pain, function, deformities and range of motion | Up to two months before surgery | 
| UCLA activity | University of California Los Angeles activity score. A score over the intensity of activities the patient engages in. | Up to two months before surgery | 
| WOMAC | patient reported outcome of pain, stifness and disability during activities of daily living. | Up to two months before surgery | 
| EQ-5d | a short quality of life measure. patient reported | Up to two months before surgery | 
| T cell count | quantitative analysis of the level of T-cells in the blood | Up to two months before surgery | 
| X-ray | an assesment of the placement of the metal cup. Inclination and anteversion. | within 2 years of surgery | 
| steps | using a pedometer 1 week prior to each check up the annual step rate is calculated | Up to two months before surgery | 
| sick leave | an assesment of the rehabilitation period following the intervention | assesed 6 months following surgery. | 
| Metal ions | Crom and cobalt | 8 weeks +/- 1 week | 
| Metal ions | Crome and cobalt | 6 months +/- 2 weeks | 
| Metal ions | crome and cobalt | 1 year +/- 1 month | 
| metal ions | crome and cobalt | 2 year +/- 1 month | 
| BMD | bone mass desity around the implant | 8 weeks +/- 1 week | 
| BMD | Bone mass density around the implant | 1 year +/- 1 month | 
| BMD | Bone mass density around the implant | 2 year +/- 1 month | 
| RSA | Radiostereometry of implant | 8 weeks +/- 1 week | 
| RSA | Radiostereometry of implant | 6 months +/- 2 weeks | 
| RSA | Radiostereometry of implant | 1 year +/- 1 month | 
| RSA | Radiostereometry of implant | 2 year +/- 1 month | 
| HHS | Harris hip score | 8 weeks +/- 1 week | 
| HHS | Harris hip score | 6 months +/- 2 weeks | 
| HHS | Harris hip score | 1 year +/- 1 month | 
| HHS | Harris hip score | 2 years +/- 1 month | 
| UCLA activity | activity score | 8 weeks +/- 1 week | 
| UCLA activity | activity score | 6 months +/- 2 weeks | 
| UCLA activity | activity score | 1 year +/- 1 month | 
| UCLA activity | activity score | 2 years +/- 1 month | 
| WOMAC | self reported function | 3 weeks | 
| WOMAC | self reported function | 6 weeks | 
| WOMAC | self reported function | 8 weeks +/- 1 week | 
| WOMAC | self reported function | 6 months +/- 2 weeks | 
| WOMAC | self reported function | 1 year +/- 1 month | 
| WOMAC | self reported function | 2 years +/- 1 month | 
| EQ-5d | quality of life | 8 weeks +/- 1 week | 
| EQ-5d | quality of life | 6 months +/- 2 weeks | 
| EQ-5d | quality of life | 1 year +/- 1 month | 
| EQ-5d | quality of life | 2 years +/- 1 month | 
| T cell count | T cell count | 8 weeks +/- 1 week | 
| T cell count | T cell count | 6 months +/- 2 weeks | 
| T cell count | T cell count | 1 year +/- 1 month | 
| T cell count | T cell count | 2 years +/- 1 month | 
| steps | steps measured by pedometer during the week prior to check up | 8 weeks +/- 1 week | 
| steps | steps measured by pedometer during the week prior to check up | 6 months +/- 2 weeks | 
| steps | steps measured by pedometer during the week prior to check up | 1 year +/- 1 month | 
| steps | steps measured by pedometer during the week prior to check up | 2 years +/- 1 month | 
| blood loss | blood loss measured in mL | during surgery | 
| days in hospital | days in hospital following surgery | from admission to discharge from hospital | 
| complications | surgery and implant related complications | within the first 2 years following surgery | 
| surgery time | time from skin is incised to skin is closed | during surgery | 
| incision length | the length of the surgical incision in cm | during surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, Replacement, Hip, Bone Density, Rehabilitation, T-Lymphocytes, Chromium Alloys