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

Maastricht University Medical Center50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

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