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:
Maastricht University Medical Center
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
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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
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 May 16, 2013