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OpenTrials
Completed

NCT Number: NCT00249054

Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

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

Completed

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Key information

Conditions

Patients Suitable for THA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Frederiksberg University Hospital

Frederiksberg, Copenhagen, 2000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

ASR hip prosthesis

Device

Implantation of resurfacing prosthesis

Other names: DuPuy ASR hip prosthesis

ReCap hip prosthesis

Device

Implantation of resurfacing prosthesis

Other names: Biomet ReCap hip prosthesis

Primary outcomes

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

    Time frame: 10 year follow up

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

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2012
First posted
Nov 7, 2005
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.