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CompletedNCT00249054Updated Mar 24, 2017

Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

An interventional study of ASR hip prosthesis and ReCap hip prosthesis in Patients Suitable for THA, sponsored by Frederiksberg University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-24.

Sponsored by Frederiksberg University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by:

Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.

Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range of motion. Scanning: DEXA and MRI

02

Conditions studied

  • Patients Suitable for THA
03

In context

Lead sponsor

Frederiksberg University Hospital is the lead sponsor of 40 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

ASA I-II,DEXA-scanning:

  • lower limit for a 55 years old women,
  • MRI normal
  • vitality in caput
  • willing to return for follow-up evaluations.

Exclusion criteria

Exclusion Criteria:

  • collum femoris \< 2 cm
  • large cysts in caput (> 1 cm)
  • mismatch between caput and acetabulum
  • caput necrosis
  • treatment with medicine which affects bone metabolism
  • impaired kidney function.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    ASR hip prosthesis

    DuPuy ASR hip prosthesis

    Device: ASR hip prosthesis · Device: ReCap hip prosthesis

  • Active comparator
    ReCap hip prosthesis

    Biomet ReCap hip prosthesis

    Device: ReCap hip prosthesis

Interventions

  • DeviceASR hip prosthesis

    Implantation of resurfacing prosthesis

    Also known as: DuPuy ASR hip prosthesis

  • DeviceReCap hip prosthesis

    Implantation of resurfacing prosthesis

    Also known as: Biomet ReCap hip prosthesis

06

What researchers measure

Primary outcomes

  1. Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.

    follow with intervals of 1 to 3 years for determination of function and prosthesis survival

    Time frame: 10 year follow up

07

Study locations

1 site
  • Frederiksberg University Hospital
    Frederiksberg, Copenhagen 2000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00249054
Lead sponsor
Frederiksberg University Hospital
Responsible party
Arne Borgwardt (Head of Dpt, Frederiksberg University Hospital) — Principal investigator
First posted
Nov 7, 2005
Start date
Nov 2005
Primary completion
Nov 2012
Last update
Mar 24, 2017

Study contacts

arne borgwardt, M.D.
study director · Frederiksberg University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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