RSA Study Using Two Types of Uncemented Acetabular Components and the Uncemented HA Coated Symax Stem

This study is currently recruiting participants.

Verified June 2012 by Maastricht University Medical Center

Sponsor:

Collaborator:

Stryker EMEA

Information provided by (Responsible Party):

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT01618084

First received: May 22, 2012

Last updated: June 11, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 22, 2012

Last Updated Date

June 11, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

prosthetic migration of the uncemented acetabular and femoral total hip components [ Time Frame: 2 years ] [ Designated as safety issue: No ]

determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01618084 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

clinical outcome and patient satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: No ]

assess clinical outcome and patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score, WOMAC, and EQ-5D questionnaires

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

RSA Study Using Two Types of Uncemented Acetabular Components and the Uncemented HA Coated Symax Stem

Official Title ^ICMJE

A Prospective Randomised Rontgen Stereophotogrammatic Analysis (RSA) Study Using the Uncemented Trident Tritanium Acetabular Component and the Uncemented HA Coated Symax Hip Stem in a Single Centre: Assessment of Implant Migration, Bone Remodeling and Clinical Function

Brief Summary

The Trident Tritanium acetabular component of a total hip prosthesis is a new developed uncemented acetabular component. In this randomized controlled trial (RCT) the tritanium cup will be compared with the Trident HA acetabular component in two equal sized groups. The Symax HA coated stem will be used as femoral component in both groups.

Study Objectives:

The primary objective is to determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique
Secondary objectives are on one hand to assess clinical outcome on the other hand assessing patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score, WOMAC, and EQ-5D questionnaires
Tertiary objective is to assess bone remodeling of the uncemented acetabular components and the HA-coated Symax hip stem using QCT derived from usinf F18-fluoride PET in a cohort of 12 consecutive patients of this RCT

A total of 50 patients will be enrolled in this RCT divided into two equal groups. Patients have to fulfill the inclusion and exclusion criteria.

All evaluations will be done pre-operatively with 2 weeks before surgery, and after surgery at 4 weeks, 3 and 6 months and 1 and 2 years.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Device: Tritanium acetabular component

Total hip arthroplasty using a tritanium uncemented acetabular component

Study Arm (s)

Experimental: Tritanium cup
Intervention: Device: Tritanium acetabular component
Active Comparator: Trident HA cup
Intervention: Device: Tritanium acetabular component

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with a BMI < 35
Patients requiring uncemented primary THA
Primary diagnosis of osteoarthritis

Exclusion Criteria:

patients with acetabular or femoral osteotomy
Patients who had a THA on the contralateral side within last 6 months
Female patients who are pregnant or planning pregnancy during the course of the study
Patients with active or suspected infection
patients with malignancy
patients with a systemic disease that would effect the subject's welfare or overall outcome of the study
Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
Patients with systemic or metabolic disorders leading to progressive bone deterioration
Patients with other illnesses which are likely to affect their outcome
Patients with known sensitivity to device materials

Gender

Both

Ages

35 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Rene ten Broeke, MD

+31 43 387 5038

r.ten.broeke@mumc.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01618084

Other Study ID Numbers ^ICMJE

MEC10-1-068, NL 33832.068.10

Has Data Monitoring Committee

Yes

Responsible Party

Maastricht University Medical Center

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

Stryker EMEA

Investigators ^ICMJE

Principal Investigator:

Lodewijk Van Rhijn, professor

Maastricht University Medical centre

Information Provided By

Maastricht University Medical Center

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top