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

Osteoarthritis Clinical Trial

— RSA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01618084
• Other study ID #: MEC10-1-068
• Secondary ID: NL 33832.068.10
• Status: Recruiting
• Phase: Phase 4
• First received: May 22, 2012
• Last updated: June 11, 2012
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2012
• Source: Maastricht University Medical Center
• Contact: Rene ten Broeke, MD
• Phone: +31 43 387 5038
• Email: r.ten.broeke[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Tritanium acetabular component
Total hip arthroplasty using a tritanium uncemented acetabular component

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Stryker European Operations BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prosthetic migration of the uncemented acetabular and femoral total hip components	determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique	2 years	No
Secondary	clinical outcome and patient satisfaction	assess clinical outcome and patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score, WOMAC, and EQ-5D questionnaires	2 years	No