Taperloc Versus Taplerloc Microplasty

March 11, 2016 updated by: Ingemar Ivarsson

Clinical Evaluation of Taperloc Total Hip System With Two Different Stem Lengths

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linkoping, Sweden, 581 85
        • University Hospital of Linkoping

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with primary osteoarthritis of the hip scheduled for THA.
  • Suitable anatomy for both stems
  • Willingness and ability to follow study-protocol

Exclusion Criteria

  • Malignancy or metastatic bone disease.
  • Any other disease severely affecting bone and mineral metabolism
  • Ongoing or previous treatment (within 5 years prior to inclusion) with steroids
  • Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives.
  • Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs.
  • Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy.
  • Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Taperloc Microplasty
Patients with primary osteoarthritis with Taperloc microplasty non inferiority
Device: Taperloc Microplasty
primary total hip arthroplasty
Active Comparator: Taperloc Standard
Patients with primary osteoarthritis Taperloc standard
Device: Taperloc standard
primary total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis
Time Frame: 2 years
2 years

Other Outcome Measures

Outcome Measure
Time Frame
Clinical outcome measures with Harris Hip Score comparing patients receiving different stems.
Time Frame: 3, 6, 12 and 24 months
3, 6, 12 and 24 months
Clinical outcome measures with Womac Score comparing patients receiving different stems.
Time Frame: 3, 6, 12 and 24 months
3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ingemar Ivarsson

Collaborators

Biomet U.K. Ltd.

Investigators

  • Principal Investigator: Ingemar IVARSSON, PhD, University Hospital of Linkoping

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBMET.CR.ROWEU1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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