Overview

This trial is active, not recruiting.

Condition osteoarthritis, hip
Treatments articular surface replacement asr, depuy, recap/magnum modular head, biomet, bimetric stem, mallory/head cup, 28 mm ceramic head, biomet, 28 mm crco head, trilogy ch cup, versys fiber stem,zimmer)
Phase phase 2
Sponsor University of Southern Denmark
Collaborator Ministry of the Interior and Health, Denmark
Start date February 2007
End date November 2009
Trial size 71 participants
Trial identifier NCT01113762, VF20050133

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
a hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint
articular surface replacement asr, depuy
posterolateral incision
(Experimental)
a standard stemmed THA but with a large metal head, and a metal-metal articulation
recap/magnum modular head, biomet
posterolateral incision
(Active Comparator)
a standard 28 mm head uncemented THA
bimetric stem, mallory/head cup, 28 mm ceramic head, biomet
posterolateral incision
(Active Comparator)
a standard stemmed uncemented THA
28 mm crco head, trilogy ch cup, versys fiber stem,zimmer)
posterolateral incision

Primary Outcomes

Measure
Range of motion
time frame: Up to two months before surgery
Range of motion
time frame: 8 weeks +/- 1 week
Range of motion
time frame: 6 months +/- 2 weeks
Range of motion
time frame: 1 year +/- 1 month
range of motion
time frame: 2 year +/- 1 month

Secondary Outcomes

Measure
Metal ions
time frame: Up to two months before surgery
BMD
time frame: Within the first week following surgery
RSA
time frame: Within the first week following surgery
HHS
time frame: Up to two months before surgery
UCLA activity
time frame: Up to two months before surgery
WOMAC
time frame: Up to two months before surgery
EQ-5d
time frame: Up to two months before surgery
T cell count
time frame: Up to two months before surgery
X-ray
time frame: within 2 years of surgery
steps
time frame: Up to two months before surgery
sick leave
time frame: assesed 6 months following surgery.
Metal ions
time frame: 8 weeks +/- 1 week
Metal ions
time frame: 6 months +/- 2 weeks
Metal ions
time frame: 1 year +/- 1 month
metal ions
time frame: 2 year +/- 1 month
BMD
time frame: 8 weeks +/- 1 week
BMD
time frame: 1 year +/- 1 month
BMD
time frame: 2 year +/- 1 month
RSA
time frame: 8 weeks +/- 1 week
RSA
time frame: 6 months +/- 2 weeks
RSA
time frame: 1 year +/- 1 month
RSA
time frame: 2 year +/- 1 month
HHS
time frame: 8 weeks +/- 1 week
HHS
time frame: 6 months +/- 2 weeks
HHS
time frame: 1 year +/- 1 month
HHS
time frame: 2 years +/- 1 month
UCLA activity
time frame: 8 weeks +/- 1 week
UCLA activity
time frame: 6 months +/- 2 weeks
UCLA activity
time frame: 1 year +/- 1 month
UCLA activity
time frame: 2 years +/- 1 month
WOMAC
time frame: 3 weeks
WOMAC
time frame: 6 weeks
WOMAC
time frame: 8 weeks +/- 1 week
WOMAC
time frame: 6 months +/- 2 weeks
WOMAC
time frame: 1 year +/- 1 month
WOMAC
time frame: 2 years +/- 1 month
EQ-5d
time frame: 8 weeks +/- 1 week
EQ-5d
time frame: 6 months +/- 2 weeks
EQ-5d
time frame: 1 year +/- 1 month
EQ-5d
time frame: 2 years +/- 1 month
T cell count
time frame: 8 weeks +/- 1 week
T cell count
time frame: 6 months +/- 2 weeks
T cell count
time frame: 1 year +/- 1 month
T cell count
time frame: 2 years +/- 1 month
steps
time frame: 8 weeks +/- 1 week
steps
time frame: 6 months +/- 2 weeks
steps
time frame: 1 year +/- 1 month
steps
time frame: 2 years +/- 1 month
blood loss
time frame: during surgery
days in hospital
time frame: from admission to discharge from hospital
complications
time frame: within the first 2 years following surgery
surgery time
time frame: during surgery
incision length
time frame: during surgery

Eligibility Criteria

Male or female participants from 40 years up to 65 years old.

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

Additional Information

Official title Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies
Principal investigator Soeren Overgaard, MD, professor, phd
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Southern Denmark.