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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Device: Tritanium acetabular component
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618084

Contacts
Contact: Rene ten Broeke, MD +31 43 387 5038 r.ten.broeke@mumc.nl

Locations
Netherlands
Maastricht UMC Recruiting
Maastricht, Netherlands
Contact: Liesbeth Jutten       l.jutten@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Stryker EMEA
Investigators
Principal Investigator: Lodewijk Van Rhijn, professor Maastricht University Medical centre
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01618084     History of Changes
Other Study ID Numbers: MEC10-1-068, NL 33832.068.10
Study First Received: May 22, 2012
Last Updated: June 11, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
hipreplacement
uncemented
migration
boneremodeling

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014