Clinical trial NCT01113762: Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty
Official title: Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis, Hip
Keywords: Arthroplasty, Replacement, Hip
Bone Density
Rehabilitation
T-Lymphocytes
Chromium Alloys
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Ministry of the Interior and Health, Denmark
name: Region Zealand
name: Zimmer Biomet
name: DePuy Orthopaedics
First posted: 2010-04-30
Enrollment: 71
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Range of motion
timeFrame: Up to two months before surgery
measure: Range of motion
timeFrame: 8 weeks +/- 1 week
measure: Range of motion
timeFrame: 6 months +/- 2 weeks
measure: Range of motion
timeFrame: 1 year +/- 1 month
measure: range of motion
timeFrame: 2 year +/- 1 month
Secondary outcomes:
measure: Metal ions
timeFrame: Up to two months before surgery
measure: BMD
timeFrame: Within the first week following surgery
measure: RSA
timeFrame: Within the first week following surgery
measure: HHS
timeFrame: Up to two months before surgery
measure: UCLA activity
timeFrame: Up to two months before surgery
measure: WOMAC
timeFrame: Up to two months before surgery
measure: EQ-5d
timeFrame: Up to two months before surgery
measure: T cell count
timeFrame: Up to two months before surgery
measure: X-ray
timeFrame: within 2 years of surgery
measure: steps
timeFrame: Up to two months before surgery
measure: sick leave
timeFrame: assesed 6 months following surgery.
measure: Metal ions
timeFrame: 8 weeks +/- 1 week
measure: Metal ions
timeFrame: 6 months +/- 2 weeks
measure: Metal ions
timeFrame: 1 year +/- 1 month
measure: metal ions
timeFrame: 2 year +/- 1 month
measure: BMD
timeFrame: 8 weeks +/- 1 week
measure: BMD
timeFrame: 1 year +/- 1 month
measure: BMD
timeFrame: 2 year +/- 1 month
measure: RSA
timeFrame: 8 weeks +/- 1 week
measure: RSA
timeFrame: 6 months +/- 2 weeks
measure: RSA
timeFrame: 1 year +/- 1 month
measure: RSA
timeFrame: 2 year +/- 1 month
measure: HHS
timeFrame: 8 weeks +/- 1 week
measure: HHS
timeFrame: 6 months +/- 2 weeks
measure: HHS
timeFrame: 1 year +/- 1 month
measure: HHS
timeFrame: 2 years +/- 1 month
measure: UCLA activity
timeFrame: 8 weeks +/- 1 week
measure: UCLA activity
timeFrame: 6 months +/- 2 weeks
measure: UCLA activity
timeFrame: 1 year +/- 1 month
measure: UCLA activity
timeFrame: 2 years +/- 1 month
measure: WOMAC
timeFrame: 3 weeks
measure: WOMAC
timeFrame: 6 weeks
measure: WOMAC
timeFrame: 8 weeks +/- 1 week
measure: WOMAC
timeFrame: 6 months +/- 2 weeks
measure: WOMAC
timeFrame: 1 year +/- 1 month
measure: WOMAC
timeFrame: 2 years +/- 1 month
measure: EQ-5d
timeFrame: 8 weeks +/- 1 week
measure: EQ-5d
timeFrame: 6 months +/- 2 weeks
measure: EQ-5d
timeFrame: 1 year +/- 1 month
measure: EQ-5d
timeFrame: 2 years +/- 1 month
measure: T cell count
timeFrame: 8 weeks +/- 1 week
measure: T cell count
timeFrame: 6 months +/- 2 weeks
measure: T cell count
timeFrame: 1 year +/- 1 month
measure: T cell count
timeFrame: 2 years +/- 1 month
measure: steps
timeFrame: 8 weeks +/- 1 week
measure: steps
timeFrame: 6 months +/- 2 weeks
measure: steps
timeFrame: 1 year +/- 1 month
measure: steps
timeFrame: 2 years +/- 1 month
measure: blood loss
timeFrame: during surgery
measure: days in hospital
timeFrame: from admission to discharge from hospital
measure: complications
timeFrame: within the first 2 years following surgery
measure: surgery time
timeFrame: during surgery
measure: incision length
timeFrame: during surgery
Other outcomes:
Locations:
city: Naestved
country: Denmark
facility: Naestved Hospital Dept. of orthop. surg.
city: Odense
country: Denmark
facility: Odense University hospital
Study officials:
affiliation: University of Southern Denmark
name: Soeren Overgaard, MD, professor, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Penny 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.
citation: Nissen 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.