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

University of Southern Denmark (SDU)

Status and phase: Unknown; Phase 2

Conditions: Osteoarthritis, Hip

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01113762

VF20050133

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 4 patient groups

resurfacing

Experimental group

Description:

a hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint

Treatment:

Device: articular surface replacement ASR, DePuy

large head THA

Experimental group

Description:

a standard stemmed THA but with a large metal head, and a metal-metal articulation

Treatment:

Device: ReCap/Magnum modular head, Biomet

28 mm ceramics-polyethylene

Active Comparator group

Description:

a standard 28 mm head uncemented THA

Treatment:

Device: Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet

28 mm metal-polyethylene THA

Active Comparator group

Description:

a standard stemmed uncemented THA

Treatment:

Device: 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)