Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty
- Conditions
- Osteoarthritis, Hip
- Interventions
- Device: articular surface replacement ASR, DePuyDevice: ReCap/Magnum modular head, BiometDevice: Bimetric stem, mallory/head cup, 28 mm ceramic head, BiometDevice: 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)
- Registration Number
- NCT01113762
- Lead Sponsor
- University of Southern Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 71
- Primary hip osteoarthritis
- Secondary osteoarthritis due to mild dysplasia
- Age from 40 to 65 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description resurfacing articular surface replacement ASR, DePuy a hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint large head THA ReCap/Magnum modular head, Biomet a standard stemmed THA but with a large metal head, and a metal-metal articulation 28 mm ceramics-polyethylene Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet a standard 28 mm head uncemented THA 28 mm metal-polyethylene THA 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer) a standard stemmed uncemented THA
- Primary Outcome Measures
Name Time Method Range of motion 1 year +/- 1 month range of motion in the hip joint
range of motion 2 year +/- 1 month range of motion in the hip joint
- Secondary Outcome Measures
Name Time Method Metal ions 1 year +/- 1 month crome and cobalt
HHS 2 years +/- 1 month Harris hip score
WOMAC 2 years +/- 1 month self reported function
RSA 2 year +/- 1 month Radiostereometry of implant
UCLA activity 2 years +/- 1 month activity score
BMD 2 year +/- 1 month Bone mass density around the implant
surgery time during surgery time from skin is incised to skin is closed
complications within the first 2 years following surgery surgery and implant related complications
EQ-5d 2 years +/- 1 month quality of life
days in hospital from admission to discharge from hospital days in hospital following surgery
T cell count 2 years +/- 1 month T cell count
X-ray within 2 years of surgery an assesment of the placement of the metal cup. Inclination and anteversion.
steps 2 years +/- 1 month steps measured by pedometer during the week prior to check up
sick leave assesed 6 months following surgery. an assesment of the rehabilitation period following the intervention
blood loss during surgery blood loss measured in mL
incision length during surgery the length of the surgical incision in cm
metal ions 2 year +/- 1 month crome and cobalt
Trial Locations
- Locations (2)
Naestved Hospital Dept. of orthop. surg.
🇩🇰Naestved, Denmark
Odense University hospital
🇩🇰Odense, Denmark