AzTrials
AzTrials

Osteoarthritis, HipPhase 2NCT01113762

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

A Phase 2 study testing articular surface replacement ASR, DePuy, ReCap/Magnum modular head, Biomet and Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet in people with Osteoarthritis, Hip, run by University of Southern Denmark at 2 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Osteoarthritis, Hip
What is being tested?
articular surface replacement ASR, DePuy, ReCap/Magnum modular head, Biomet and Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
2 sitesDenmark
Study dates
Feb 2007to Nov 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary hip osteoarthritis
  • Secondary osteoarthritis due to mild dysplasia
  • Age from 40 to 65 years

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Naestved Hospital Dept. of orthop. surg.

    Næstved, 4700

  • Odense University hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies

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.

Being tested
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)
Keywords
Arthroplasty, Replacement, Hip, Bone Density, Rehabilitation, T-Lymphocytes, Chromium Alloys
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • articular surface replacement ASR, DePuyDevice

    posterolateral incision

  • ReCap/Magnum modular head, BiometDevice

    posterolateral incision

  • Bimetric stem, mallory/head cup, 28 mm ceramic head, BiometDevice

    posterolateral incision

  • 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)Device

    posterolateral incision

Study groups in NCT01113762
Study groupRoleWhat they receive
resurfacingExperimentala hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint
Receives: Device: articular surface replacement ASR, DePuy
large head THAExperimentala standard stemmed THA but with a large metal head, and a metal-metal articulation
Receives: Device: ReCap/Magnum modular head, Biomet
28 mm ceramics-polyethyleneActive comparatora standard 28 mm head uncemented THA
Receives: Device: Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet
28 mm metal-polyethylene THAActive comparatora standard stemmed uncemented THA
Receives: Device: 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Range of motion

    range of motion in the hip joint evaluated by goniometer

    Measured: Up to two months before surgery

  2. Range of motion

    Range of motion of the hip joint

    Measured: 8 weeks +/- 1 week

  3. Range of motion

    range of motion in the hip joint

    Measured: 6 months +/- 2 weeks

  4. Range of motion

    range of motion in the hip joint

    Measured: 1 year +/- 1 month

  5. range of motion

    range of motion in the hip joint

    Measured: 2 year +/- 1 month

Secondary outcomes (53)

  1. Metal ions

    Crome and cobalt ions in serum and whole blood.

    Measured: Up to two months before surgery

  2. BMD

    bone mass density around the implants

    Measured: Within the first week following surgery

  3. RSA

    radiostereommetry. Measurement of micromotions (subsidence, rotation and translations)of the implant in relation to the bone

    Measured: Within the first week following surgery

  4. HHS

    Harris hip score. An investigator asssesed hip questionnaire including pain, function, deformities and range of motion

    Measured: Up to two months before surgery

  5. UCLA activity

    University of California Los Angeles activity score. A score over the intensity of activities the patient engages in.

    Measured: Up to two months before surgery

  6. WOMAC

    patient reported outcome of pain, stifness and disability during activities of daily living.

    Measured: Up to two months before surgery

  7. EQ-5d

    a short quality of life measure. patient reported

    Measured: Up to two months before surgery

  8. T cell count

    quantitative analysis of the level of T-cells in the blood

    Measured: Up to two months before surgery

  9. X-ray

    an assesment of the placement of the metal cup. Inclination and anteversion.

    Measured: within 2 years of surgery

  10. steps

    using a pedometer 1 week prior to each check up the annual step rate is calculated

    Measured: Up to two months before surgery

  11. sick leave

    an assesment of the rehabilitation period following the intervention

    Measured: assesed 6 months following surgery.

  12. Metal ions

    Crom and cobalt

    Measured: 8 weeks +/- 1 week

  13. Metal ions

    Crome and cobalt

    Measured: 6 months +/- 2 weeks

  14. Metal ions

    crome and cobalt

    Measured: 1 year +/- 1 month

  15. metal ions

    crome and cobalt

    Measured: 2 year +/- 1 month

  16. BMD

    bone mass desity around the implant

    Measured: 8 weeks +/- 1 week

  17. BMD

    Bone mass density around the implant

    Measured: 1 year +/- 1 month

  18. BMD

    Bone mass density around the implant

    Measured: 2 year +/- 1 month

  19. RSA

    Radiostereometry of implant

    Measured: 8 weeks +/- 1 week

  20. RSA

    Radiostereometry of implant

    Measured: 6 months +/- 2 weeks

  21. RSA

    Radiostereometry of implant

    Measured: 1 year +/- 1 month

  22. RSA

    Radiostereometry of implant

    Measured: 2 year +/- 1 month

  23. HHS

    Harris hip score

    Measured: 8 weeks +/- 1 week

  24. HHS

    Harris hip score

    Measured: 6 months +/- 2 weeks

  25. HHS

    Harris hip score

    Measured: 1 year +/- 1 month

  26. HHS

    Harris hip score

    Measured: 2 years +/- 1 month

  27. UCLA activity

    activity score

    Measured: 8 weeks +/- 1 week

  28. UCLA activity

    activity score

    Measured: 6 months +/- 2 weeks

  29. UCLA activity

    activity score

    Measured: 1 year +/- 1 month

  30. UCLA activity

    activity score

    Measured: 2 years +/- 1 month

  31. WOMAC

    self reported function

    Measured: 3 weeks

  32. WOMAC

    self reported function

    Measured: 6 weeks

  33. WOMAC

    self reported function

    Measured: 8 weeks +/- 1 week

  34. WOMAC

    self reported function

    Measured: 6 months +/- 2 weeks

  35. WOMAC

    self reported function

    Measured: 1 year +/- 1 month

  36. WOMAC

    self reported function

    Measured: 2 years +/- 1 month

  37. EQ-5d

    quality of life

    Measured: 8 weeks +/- 1 week

  38. EQ-5d

    quality of life

    Measured: 6 months +/- 2 weeks

  39. EQ-5d

    quality of life

    Measured: 1 year +/- 1 month

  40. EQ-5d

    quality of life

    Measured: 2 years +/- 1 month

  41. T cell count

    T cell count

    Measured: 8 weeks +/- 1 week

  42. T cell count

    T cell count

    Measured: 6 months +/- 2 weeks

  43. T cell count

    T cell count

    Measured: 1 year +/- 1 month

  44. T cell count

    T cell count

    Measured: 2 years +/- 1 month

  45. steps

    steps measured by pedometer during the week prior to check up

    Measured: 8 weeks +/- 1 week

  46. steps

    steps measured by pedometer during the week prior to check up

    Measured: 6 months +/- 2 weeks

  47. steps

    steps measured by pedometer during the week prior to check up

    Measured: 1 year +/- 1 month

  48. steps

    steps measured by pedometer during the week prior to check up

    Measured: 2 years +/- 1 month

  49. blood loss

    blood loss measured in mL

    Measured: during surgery

  50. days in hospital

    days in hospital following surgery

    Measured: from admission to discharge from hospital

  51. complications

    surgery and implant related complications

    Measured: within the first 2 years following surgery

  52. surgery time

    time from skin is incised to skin is closed

    Measured: during surgery

  53. incision length

    the length of the surgical incision in cm

    Measured: during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2010 (estimated)
  2. Study startFeb 2007
  3. Primary completionNov 2009
  4. Study completionNov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01113762
Sponsor's protocol ID
VF20050133
Status last verified
Dec 2017
First submitted
28 Apr 2010
Last updated
19 Dec 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23597114

  • 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.

    PubMed 23530872

  • 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.

    PubMed 21975150

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing articular surface replacement ASR, DePuy, ReCap/Magnum modular head, Biomet and Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet in people with Osteoarthritis, Hip, run by University of Southern Denmark at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Range of motion (time frame: Up to two months before surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01113762, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in