Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- University of Southern Denmark
- Enrollment
- 71
- Locations
- 2
- Primary Endpoint
- Range of motion
- Last Updated
- 8 years ago
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.
Investigators
jeannette ostergaard penny
MD, PhD
University of Southern Denmark
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
Outcomes
Primary Outcomes
Range of motion
Time Frame: 1 year +/- 1 month
range of motion in the hip joint
range of motion
Time Frame: 2 year +/- 1 month
range of motion in the hip joint
Secondary Outcomes
- Metal ions(1 year +/- 1 month)
- HHS(2 years +/- 1 month)
- WOMAC(2 years +/- 1 month)
- RSA(2 year +/- 1 month)
- UCLA activity(2 years +/- 1 month)
- surgery time(during surgery)
- BMD(2 year +/- 1 month)
- metal ions(2 year +/- 1 month)
- complications(within the first 2 years following surgery)
- EQ-5d(2 years +/- 1 month)
- days in hospital(from admission to discharge from hospital)
- T cell count(2 years +/- 1 month)
- X-ray(within 2 years of surgery)
- steps(2 years +/- 1 month)
- sick leave(assesed 6 months following surgery.)
- blood loss(during surgery)
- incision length(during surgery)