Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

Patients Suitable for THA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249054
• Other study ID #: KF11279577
• Status: Completed
• Phase: N/A
• First received: November 3, 2005
• Last updated: March 22, 2017
• Start date: November 2005

Study information

• Verified date: March 2017
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patients Suitable for THA

Intervention

Device:
• ASR hip prosthesis
Implantation of resurfacing prosthesis
• ReCap hip prosthesis
Implantation of resurfacing prosthesis

Locations

Country	Name	City	State
Denmark	Frederiksberg University Hospital	Frederiksberg	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 year follow up