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

May 22, 2012
June 11, 2012
November 2011
November 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01618084 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
RSA Study Using Two Types of Uncemented Acetabular Components and the Uncemented HA Coated Symax Stem
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Osteoarthritis
Device: Tritanium acetabular component
Total hip arthroplasty using a tritanium uncemented acetabular component
  • Experimental: Tritanium cup
    Intervention: Device: Tritanium acetabular component
  • Active Comparator: Trident HA cup
    Intervention: Device: Tritanium acetabular component
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
35 Years to 70 Years
No
Contact: Rene ten Broeke, MD +31 43 387 5038 r.ten.broeke@mumc.nl
Netherlands
 
NCT01618084
MEC10-1-068, NL 33832.068.10
Yes
Maastricht University Medical Center
Maastricht University Medical Center
Stryker EMEA
Principal Investigator: Lodewijk Van Rhijn, professor Maastricht University Medical centre
Maastricht University Medical Center
June 2012

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