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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Southern Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ministry of the Interior and Health, Denmark
Region Zealand
Biomet, Inc.
DePuy Orthopaedics
ALS Laboratory Group
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01113762
First received: April 28, 2010
Last updated: April 29, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Hip
Device: articular surface replacement ASR, DePuy
Device: ReCap/Magnum modular head, Biomet
Device: Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet
Device: 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Range of motion [ Time Frame: Up to two months before surgery ] [ Designated as safety issue: No ]
    range of motion in the hip joint evaluated by goniometer

  • Range of motion [ Time Frame: 8 weeks +/- 1 week ] [ Designated as safety issue: No ]
    Range of motion of the hip joint

  • Range of motion [ Time Frame: 6 months +/- 2 weeks ] [ Designated as safety issue: No ]
    range of motion in the hip joint

  • Range of motion [ Time Frame: 1 year +/- 1 month ] [ Designated as safety issue: No ]
    range of motion in the hip joint

  • range of motion [ Time Frame: 2 year +/- 1 month ] [ Designated as safety issue: No ]
    range of motion in the hip joint


Secondary Outcome Measures:
  • Metal ions [ Time Frame: Up to two months before surgery ] [ Designated as safety issue: Yes ]
    Crome and cobalt ions in serum and whole blood.

  • BMD [ Time Frame: Within the first week following surgery ] [ Designated as safety issue: No ]
    bone mass density around the implants

  • RSA [ Time Frame: Within the first week following surgery ] [ Designated as safety issue: Yes ]
    radiostereommetry. Measurement of micromotions (subsidence, rotation and translations)of the implant in relation to the bone

  • HHS [ Time Frame: Up to two months before surgery ] [ Designated as safety issue: No ]
    Harris hip score. An investigator asssesed hip questionnaire including pain, function, deformities and range of motion

  • UCLA activity [ Time Frame: Up to two months before surgery ] [ Designated as safety issue: No ]
    University of California Los Angeles activity score. A score over the intensity of activities the patient engages in.

  • WOMAC [ Time Frame: Up to two months before surgery ] [ Designated as safety issue: No ]
    patient reported outcome of pain, stifness and disability during activities of daily living.

  • EQ-5d [ Time Frame: Up to two months before surgery ] [ Designated as safety issue: No ]
    a short quality of life measure. patient reported

  • T cell count [ Time Frame: Up to two months before surgery ] [ Designated as safety issue: Yes ]
    quantitative analysis of the level of T-cells in the blood

  • X-ray [ Time Frame: within 2 years of surgery ] [ Designated as safety issue: No ]
    an assesment of the placement of the metal cup. Inclination and anteversion.

  • steps [ Time Frame: Up to two months before surgery ] [ Designated as safety issue: No ]
    using a pedometer 1 week prior to each check up the annual step rate is calculated

  • sick leave [ Time Frame: assesed 6 months following surgery. ] [ Designated as safety issue: No ]
    an assesment of the rehabilitation period following the intervention

  • Metal ions [ Time Frame: 8 weeks +/- 1 week ] [ Designated as safety issue: Yes ]
    Crom and cobalt

  • Metal ions [ Time Frame: 6 months +/- 2 weeks ] [ Designated as safety issue: Yes ]
    Crome and cobalt

  • Metal ions [ Time Frame: 1 year +/- 1 month ] [ Designated as safety issue: Yes ]
    crome and cobalt

  • metal ions [ Time Frame: 2 year +/- 1 month ] [ Designated as safety issue: Yes ]
    crome and cobalt

  • BMD [ Time Frame: 8 weeks +/- 1 week ] [ Designated as safety issue: No ]
    bone mass desity around the implant

  • BMD [ Time Frame: 1 year +/- 1 month ] [ Designated as safety issue: No ]
    Bone mass density around the implant

  • BMD [ Time Frame: 2 year +/- 1 month ] [ Designated as safety issue: No ]
    Bone mass density around the implant

  • RSA [ Time Frame: 8 weeks +/- 1 week ] [ Designated as safety issue: Yes ]
    Radiostereometry of implant

  • RSA [ Time Frame: 6 months +/- 2 weeks ] [ Designated as safety issue: Yes ]
    Radiostereometry of implant

  • RSA [ Time Frame: 1 year +/- 1 month ] [ Designated as safety issue: Yes ]
    Radiostereometry of implant

  • RSA [ Time Frame: 2 year +/- 1 month ] [ Designated as safety issue: Yes ]
    Radiostereometry of implant

  • HHS [ Time Frame: 8 weeks +/- 1 week ] [ Designated as safety issue: No ]
    Harris hip score

  • HHS [ Time Frame: 6 months +/- 2 weeks ] [ Designated as safety issue: No ]
    Harris hip score

  • HHS [ Time Frame: 1 year +/- 1 month ] [ Designated as safety issue: No ]
    Harris hip score

  • HHS [ Time Frame: 2 years +/- 1 month ] [ Designated as safety issue: No ]
    Harris hip score

  • UCLA activity [ Time Frame: 8 weeks +/- 1 week ] [ Designated as safety issue: No ]
    activity score

  • UCLA activity [ Time Frame: 6 months +/- 2 weeks ] [ Designated as safety issue: No ]
    activity score

  • UCLA activity [ Time Frame: 1 year +/- 1 month ] [ Designated as safety issue: No ]
    activity score

  • UCLA activity [ Time Frame: 2 years +/- 1 month ] [ Designated as safety issue: No ]
    activity score

  • WOMAC [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    self reported function

  • WOMAC [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    self reported function

  • WOMAC [ Time Frame: 8 weeks +/- 1 week ] [ Designated as safety issue: No ]
    self reported function

  • WOMAC [ Time Frame: 6 months +/- 2 weeks ] [ Designated as safety issue: No ]
    self reported function

  • WOMAC [ Time Frame: 1 year +/- 1 month ] [ Designated as safety issue: No ]
    self reported function

  • WOMAC [ Time Frame: 2 years +/- 1 month ] [ Designated as safety issue: No ]
    self reported function

  • EQ-5d [ Time Frame: 8 weeks +/- 1 week ] [ Designated as safety issue: No ]
    quality of life

  • EQ-5d [ Time Frame: 6 months +/- 2 weeks ] [ Designated as safety issue: No ]
    quality of life

  • EQ-5d [ Time Frame: 1 year +/- 1 month ] [ Designated as safety issue: No ]
    quality of life

  • EQ-5d [ Time Frame: 2 years +/- 1 month ] [ Designated as safety issue: No ]
    quality of life

  • T cell count [ Time Frame: 8 weeks +/- 1 week ] [ Designated as safety issue: Yes ]
    T cell count

  • T cell count [ Time Frame: 6 months +/- 2 weeks ] [ Designated as safety issue: Yes ]
    T cell count

  • T cell count [ Time Frame: 1 year +/- 1 month ] [ Designated as safety issue: Yes ]
    T cell count

  • T cell count [ Time Frame: 2 years +/- 1 month ] [ Designated as safety issue: Yes ]
    T cell count

  • steps [ Time Frame: 8 weeks +/- 1 week ] [ Designated as safety issue: No ]
    steps measured by pedometer during the week prior to check up

  • steps [ Time Frame: 6 months +/- 2 weeks ] [ Designated as safety issue: No ]
    steps measured by pedometer during the week prior to check up

  • steps [ Time Frame: 1 year +/- 1 month ] [ Designated as safety issue: No ]
    steps measured by pedometer during the week prior to check up

  • steps [ Time Frame: 2 years +/- 1 month ] [ Designated as safety issue: No ]
    steps measured by pedometer during the week prior to check up

  • blood loss [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]
    blood loss measured in mL

  • days in hospital [ Time Frame: from admission to discharge from hospital ] [ Designated as safety issue: No ]
    days in hospital following surgery

  • complications [ Time Frame: within the first 2 years following surgery ] [ Designated as safety issue: Yes ]
    surgery and implant related complications

  • surgery time [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]
    time from skin is incised to skin is closed

  • incision length [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    the length of the surgical incision in cm


Enrollment: 71
Study Start Date: February 2007
Estimated Study Completion Date: November 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: resurfacing
a hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint
Device: articular surface replacement ASR, DePuy
posterolateral incision
Experimental: large head THA
a standard stemmed THA but with a large metal head, and a metal-metal articulation
Device: ReCap/Magnum modular head, Biomet
posterolateral incision
Active Comparator: 28 mm ceramics-polyethylene
a standard 28 mm head uncemented THA
Device: Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet
posterolateral incision
Active Comparator: 28 mm metal-polyethylene THA
a standard stemmed uncemented THA
Device: 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)
posterolateral incision

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113762

Locations
Denmark
Naestved Hospital Dept. of orthop. surg.
Naestved, Denmark, 4700
Odense University hospital
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Ministry of the Interior and Health, Denmark
Region Zealand
Biomet, Inc.
DePuy Orthopaedics
ALS Laboratory Group
Investigators
Principal Investigator: Soeren Overgaard, MD, professor, phd University of Southern Denmark
  More Information

Additional Information:
No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Soeren Overgaard/Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01113762     History of Changes
Other Study ID Numbers: VF20050133
Study First Received: April 28, 2010
Last Updated: April 29, 2010
Health Authority: Denmark: The Danish Data Protection Agency

Keywords provided by University of Southern Denmark:
Arthroplasty, Replacement, Hip
Bone Density
Rehabilitation
T-Lymphocytes
Chromium Alloys

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cimetidine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014