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

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ClinicalTrials.gov Identifier: NCT01113762
Recruitment Status : Active, not recruiting
First Posted : April 30, 2010
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
Ministry of the Interior and Health, Denmark
Region Zealand
Zimmer Biomet
DePuy Orthopaedics
Information provided by (Responsible Party):
jeannette ostergaard penny, University of Southern Denmark

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.


Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies
Study Start Date : February 2007
Actual Primary Completion Date : November 2009
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Range of motion [ Time Frame: Up to two months before surgery ]
    range of motion in the hip joint evaluated by goniometer

  2. Range of motion [ Time Frame: 8 weeks +/- 1 week ]
    Range of motion of the hip joint

  3. Range of motion [ Time Frame: 6 months +/- 2 weeks ]
    range of motion in the hip joint

  4. Range of motion [ Time Frame: 1 year +/- 1 month ]
    range of motion in the hip joint

  5. range of motion [ Time Frame: 2 year +/- 1 month ]
    range of motion in the hip joint


Secondary Outcome Measures :
  1. Metal ions [ Time Frame: Up to two months before surgery ]
    Crome and cobalt ions in serum and whole blood.

  2. BMD [ Time Frame: Within the first week following surgery ]
    bone mass density around the implants

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

  4. HHS [ Time Frame: Up to two months before surgery ]
    Harris hip score. An investigator asssesed hip questionnaire including pain, function, deformities and range of motion

  5. UCLA activity [ Time Frame: Up to two months before surgery ]
    University of California Los Angeles activity score. A score over the intensity of activities the patient engages in.

  6. WOMAC [ Time Frame: Up to two months before surgery ]
    patient reported outcome of pain, stifness and disability during activities of daily living.

  7. EQ-5d [ Time Frame: Up to two months before surgery ]
    a short quality of life measure. patient reported

  8. T cell count [ Time Frame: Up to two months before surgery ]
    quantitative analysis of the level of T-cells in the blood

  9. X-ray [ Time Frame: within 2 years of surgery ]
    an assesment of the placement of the metal cup. Inclination and anteversion.

  10. steps [ Time Frame: Up to two months before surgery ]
    using a pedometer 1 week prior to each check up the annual step rate is calculated

  11. sick leave [ Time Frame: assesed 6 months following surgery. ]
    an assesment of the rehabilitation period following the intervention

  12. Metal ions [ Time Frame: 8 weeks +/- 1 week ]
    Crom and cobalt

  13. Metal ions [ Time Frame: 6 months +/- 2 weeks ]
    Crome and cobalt

  14. Metal ions [ Time Frame: 1 year +/- 1 month ]
    crome and cobalt

  15. metal ions [ Time Frame: 2 year +/- 1 month ]
    crome and cobalt

  16. BMD [ Time Frame: 8 weeks +/- 1 week ]
    bone mass desity around the implant

  17. BMD [ Time Frame: 1 year +/- 1 month ]
    Bone mass density around the implant

  18. BMD [ Time Frame: 2 year +/- 1 month ]
    Bone mass density around the implant

  19. RSA [ Time Frame: 8 weeks +/- 1 week ]
    Radiostereometry of implant

  20. RSA [ Time Frame: 6 months +/- 2 weeks ]
    Radiostereometry of implant

  21. RSA [ Time Frame: 1 year +/- 1 month ]
    Radiostereometry of implant

  22. RSA [ Time Frame: 2 year +/- 1 month ]
    Radiostereometry of implant

  23. HHS [ Time Frame: 8 weeks +/- 1 week ]
    Harris hip score

  24. HHS [ Time Frame: 6 months +/- 2 weeks ]
    Harris hip score

  25. HHS [ Time Frame: 1 year +/- 1 month ]
    Harris hip score

  26. HHS [ Time Frame: 2 years +/- 1 month ]
    Harris hip score

  27. UCLA activity [ Time Frame: 8 weeks +/- 1 week ]
    activity score

  28. UCLA activity [ Time Frame: 6 months +/- 2 weeks ]
    activity score

  29. UCLA activity [ Time Frame: 1 year +/- 1 month ]
    activity score

  30. UCLA activity [ Time Frame: 2 years +/- 1 month ]
    activity score

  31. WOMAC [ Time Frame: 3 weeks ]
    self reported function

  32. WOMAC [ Time Frame: 6 weeks ]
    self reported function

  33. WOMAC [ Time Frame: 8 weeks +/- 1 week ]
    self reported function

  34. WOMAC [ Time Frame: 6 months +/- 2 weeks ]
    self reported function

  35. WOMAC [ Time Frame: 1 year +/- 1 month ]
    self reported function

  36. WOMAC [ Time Frame: 2 years +/- 1 month ]
    self reported function

  37. EQ-5d [ Time Frame: 8 weeks +/- 1 week ]
    quality of life

  38. EQ-5d [ Time Frame: 6 months +/- 2 weeks ]
    quality of life

  39. EQ-5d [ Time Frame: 1 year +/- 1 month ]
    quality of life

  40. EQ-5d [ Time Frame: 2 years +/- 1 month ]
    quality of life

  41. T cell count [ Time Frame: 8 weeks +/- 1 week ]
    T cell count

  42. T cell count [ Time Frame: 6 months +/- 2 weeks ]
    T cell count

  43. T cell count [ Time Frame: 1 year +/- 1 month ]
    T cell count

  44. T cell count [ Time Frame: 2 years +/- 1 month ]
    T cell count

  45. steps [ Time Frame: 8 weeks +/- 1 week ]
    steps measured by pedometer during the week prior to check up

  46. steps [ Time Frame: 6 months +/- 2 weeks ]
    steps measured by pedometer during the week prior to check up

  47. steps [ Time Frame: 1 year +/- 1 month ]
    steps measured by pedometer during the week prior to check up

  48. steps [ Time Frame: 2 years +/- 1 month ]
    steps measured by pedometer during the week prior to check up

  49. blood loss [ Time Frame: during surgery ]
    blood loss measured in mL

  50. days in hospital [ Time Frame: from admission to discharge from hospital ]
    days in hospital following surgery

  51. complications [ Time Frame: within the first 2 years following surgery ]
    surgery and implant related complications

  52. surgery time [ Time Frame: during surgery ]
    time from skin is incised to skin is closed

  53. incision length [ Time Frame: during surgery ]
    the length of the surgical incision in cm



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Zimmer Biomet
DePuy Orthopaedics
Investigators
Principal Investigator: Soeren Overgaard, MD, professor, phd University of Southern Denmark

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: jeannette ostergaard penny, MD, PhD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01113762     History of Changes
Other Study ID Numbers: VF20050133
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Keywords provided by jeannette ostergaard penny, 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
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors