Taperloc Versus Taplerloc Microplasty

Not Applicable

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT00757107
• Lead Sponsor: Ingemar Ivarsson

Brief Summary

This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis

Detailed Description

Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study.

Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.

Study Timeline

• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Study Start: 2011-10
• Primary Completion: 2014-10
• Study Completion: 2015-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame:	bone mineral density (BMD) measured postoperatively at 2 years

Secondary Outcome Measures

Name	Time	Method
Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis	2 years

Trial Locations

Locations (1)

University hospital of Linkoping; 🇸🇪 Linkoping, Sweden