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

Maastricht University Medical Centre (MUMC)

Status and phase

Unknown

Phase 4

Conditions

Osteoarthritis

Treatments

Device: Tritanium acetabular component

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01618084

MEC10-1-068

NL 33832.068.10 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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