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

June 11, 2012 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

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

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

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tritanium cup
Device: Tritanium acetabular component
Total hip arthroplasty using a tritanium uncemented acetabular component
ACTIVE_COMPARATOR: Trident HA cup
Device: Tritanium acetabular component
Total hip arthroplasty using a tritanium uncemented acetabular component

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prosthetic migration of the uncemented acetabular and femoral total hip components
Time Frame: 2 years
determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcome and patient satisfaction
Time Frame: 2 years
assess clinical outcome and patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score, WOMAC, and EQ-5D questionnaires
2 years

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Collaborators

Stryker European Operations BV

Investigators

  • Principal Investigator: Lodewijk Van Rhijn, professor, Maastricht University Medical Centre

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

November 1, 2011

Primary Completion (ANTICIPATED)

November 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (ESTIMATE)

June 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 11, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC10-1-068
  • NL 33832.068.10 (OTHER: CCMO)

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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