Osteoarthritis, Hip
Conditions
Keywords
Arthroplasty, Replacement, Hip, Bone Density, Rehabilitation, T-Lymphocytes, Chromium Alloys
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.
Interventions
DEVICEarticular surface replacement ASR, DePuy
posterolateral incision
DEVICEReCap/Magnum modular head, Biomet
posterolateral incision
DEVICEBimetric stem, mallory/head cup, 28 mm ceramic head, Biomet
posterolateral incision
DEVICE28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)
posterolateral incision
Sponsors
Ministry of the Interior and Health, Denmark
Region Zealand
Zimmer Biomet
DePuy Orthopaedics
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion | Up to two months before surgery | range of motion in the hip joint evaluated by goniometer |
| range of motion | 2 year +/- 1 month | range of motion in the hip joint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSA | Within the first week following surgery | radiostereommetry. Measurement of micromotions (subsidence, rotation and translations)of the implant in relation to the bone |
| HHS | Up to two months before surgery | Harris hip score. An investigator asssesed hip questionnaire including pain, function, deformities and range of motion |
| UCLA activity | Up to two months before surgery | University of California Los Angeles activity score. A score over the intensity of activities the patient engages in. |
| WOMAC | Up to two months before surgery | patient reported outcome of pain, stifness and disability during activities of daily living. |
| EQ-5d | Up to two months before surgery | a short quality of life measure. patient reported |
| T cell count | Up to two months before surgery | quantitative analysis of the level of T-cells in the blood |
| X-ray | within 2 years of surgery | an assesment of the placement of the metal cup. Inclination and anteversion. |
| Metal ions | Up to two months before surgery | Crome and cobalt ions in serum and whole blood. |
| sick leave | assesed 6 months following surgery. | an assesment of the rehabilitation period following the intervention |
| metal ions | 2 year +/- 1 month | crome and cobalt |
| blood loss | during surgery | blood loss measured in mL |
| days in hospital | from admission to discharge from hospital | days in hospital following surgery |
| complications | within the first 2 years following surgery | surgery and implant related complications |
| surgery time | during surgery | time from skin is incised to skin is closed |
| incision length | during surgery | the length of the surgical incision in cm |
| steps | Up to two months before surgery | using a pedometer 1 week prior to each check up the annual step rate is calculated |
| BMD | Within the first week following surgery | bone mass density around the implants |
Countries
Denmark
Outcome results
None listed