Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00249054

Enrollment

Registered

2005-11-07

Start date

2005-11-30

Completion date

Unknown

Last updated

2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Suitable for THA

Brief 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

Interventions

DEVICEASR hip prosthesis

Implantation of resurfacing prosthesis

DEVICEReCap hip prosthesis

Implantation of resurfacing prosthesis

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.	10 year follow up	follow with intervals of 1 to 3 years for determination of function and prosthesis survival

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026