Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty
Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies
1 other identifier
interventional
71
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2007
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 28, 2010
CompletedFirst Posted
Study publicly available on registry
April 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedDecember 19, 2017
December 1, 2017
2.8 years
April 28, 2010
December 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Range of motion
range of motion in the hip joint evaluated by goniometer
Up to two months before surgery
Range of motion
Range of motion of the hip joint
8 weeks +/- 1 week
Range of motion
range of motion in the hip joint
6 months +/- 2 weeks
Range of motion
range of motion in the hip joint
1 year +/- 1 month
range of motion
range of motion in the hip joint
2 year +/- 1 month
Secondary Outcomes (53)
Metal ions
Up to two months before surgery
BMD
Within the first week following surgery
RSA
Within the first week following surgery
HHS
Up to two months before surgery
UCLA activity
Up to two months before surgery
- +48 more secondary outcomes
Study Arms (4)
resurfacing
EXPERIMENTALa hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint
large head THA
EXPERIMENTALa standard stemmed THA but with a large metal head, and a metal-metal articulation
28 mm ceramics-polyethylene
ACTIVE COMPARATORa standard 28 mm head uncemented THA
28 mm metal-polyethylene THA
ACTIVE COMPARATORa standard stemmed uncemented THA
Interventions
posterolateral incision
posterolateral incision
Eligibility Criteria
You may qualify if:
- Primary hip osteoarthritis
- Secondary osteoarthritis due to mild dysplasia
- Age from 40 to 65 years
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- Ministry of the Interior and Health, Denmarkcollaborator
- Region Zealandcollaborator
- Zimmer Biometcollaborator
- DePuy Orthopaedicscollaborator
Study Sites (2)
Naestved Hospital Dept. of orthop. surg.
Næstved, 4700, Denmark
Odense University hospital
Odense, 5000, Denmark
Related Publications (3)
Penny JO, Varmarken JE, Ovesen O, Nielsen C, Overgaard S. Metal ion levels and lymphocyte counts: ASR hip resurfacing prosthesis vs. standard THA: 2-year results from a randomized study. Acta Orthop. 2013 Apr;84(2):130-7. doi: 10.3109/17453674.2013.784657.
PMID: 23597114DERIVEDPenny JO, Ovesen O, Varmarken JE, Overgaard S. Similar range of motion and function after resurfacing large-head or standard total hip arthroplasty. Acta Orthop. 2013 Jun;84(3):246-53. doi: 10.3109/17453674.2013.788435. Epub 2013 Mar 26.
PMID: 23530872DERIVEDNissen T, Douw K, Overgaard S. Patient-reported outcome of hip resurfacing arthroplasty and standard total hip replacement after short-term follow-up. Dan Med Bull. 2011 Oct;58(10):A4310.
PMID: 21975150DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soeren Overgaard, MD, professor, phd
University of Southern Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 28, 2010
First Posted
April 30, 2010
Study Start
February 1, 2007
Primary Completion
November 1, 2009
Study Completion
November 1, 2019
Last Updated
December 19, 2017
Record last verified: 2017-12