Clinical Evaluation of Taperloc Total Hip System With Differing Surface Coatings. - Full Text View

Sponsored by:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00757107

Purpose

This evaluation is being conducted to evaluate the safety and performance of the Taperloc Total Hip System with two different types of applied surface coating. The information from this evaluation will also provide a European Orthopaedic Outcomes Audit.

The efficacy and performance of the device will be assessed by comparison of pain, function and range of motion measured pre-operatively and post-operatively using recognised clinical scoring systems. Secondary efficacy and performance will be determined by radiographic (measurement of lucency) evaluation .

Implant stability will be assessed by R.S.A measurements.

The incidence of complications and revision rates will also be recorded

Condition	Intervention
Primary Cementless Total Hip Arthroplasty	Device: Cementless primary total hip arthroplasty Stem with Ti + Plasma HA Device: Cementless primary total hip arthroplasty Stem with Ti + BoneMaster HA

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Evaluation of Taperloc Total Hip System With Differing Surface Coatings.

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Pain, Function and Range of Motion [ Time Frame: 24months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

RSA [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Complication [ Time Frame: Anytime ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	November 2003
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Stem with Ti + BoneMaster HA	Device: Cementless primary total hip arthroplasty Stem with Ti + BoneMaster HA Cementless primary total hip arthroplasty Stem with Ti + BoneMaster HA
2: Active Comparator Stem with Ti + Plasma HA	Device: Cementless primary total hip arthroplasty Stem with Ti + Plasma HA Cementless primary total hip arthroplasty Stem with Ti + Plasma HA

Detailed Description:

The efficacy of the two implant types will be determined by patient clinical scores and implant survivorship. The clinical score being employed being the Harris Hip score.

The effect of the coatings on the fixation of the implants will be assessed radiographically and by changes in bone density surrounding the implants.

This will be measured using DEXA.

The Stability of the implant types will be assessed by R.S.A . Instrumented implants will be used to stem determine changes in migration angulation and rotation at 6,12 and 24 months post operatively.

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Subject Inclusion:

Subjects selected for this evaluation will be grouped by initial diagnosis into one of the following diagnostic groups:-

Specifically:

Eligible for primary total hip arthroplasty
Under 80 years of age.

General:

Selection of subjects for this evaluation should include the following considerations:-

A pre-operative level of pain and function the same as for conventional joint replacement.
A likelihood of obtaining relief of pain and improved function.
Full skeletal maturity.
Ability to follow instructions.
Good general health for age.
Willing to return for follow-up evaluations.
No bias to sex.

Subjects will be excluded if:

They are not skeletally mature.
Over 80 years old.
Unable to follow instructions.
Unwilling to return for follow up.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757107

Locations

Norway
Ullevol Hospital
Oslo, Norway

Sponsors and Collaborators

Biomet, Inc.

Investigators

Principal Investigator:

L Norslatten, MD

Ullevol Hospital

More Information

No publications provided

Responsible Party:	Biomet UK ( David Stephenson )
Study ID Numbers:	BMET UK 03
Study First Received:	September 19, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00757107 History of Changes
Health Authority:	Norway:Regional komite for medisinsk forskingsetikk

ClinicalTrials.gov processed this record on May 07, 2009