NCT01618084

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

3 years

First QC Date

May 22, 2012

Last Update Submit

June 11, 2012

Conditions

Osteoarthritis

Keywords

hipreplacementuncementedmigrationboneremodeling

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • clinical outcome and patient satisfaction

    2 years

Study Arms (2)

Tritanium cup

EXPERIMENTAL
Device: Tritanium acetabular component

Trident HA cup

ACTIVE COMPARATOR
Device: Tritanium acetabular component

Interventions

Tritanium acetabular componentDEVICE

Total hip arthroplasty using a tritanium uncemented acetabular component

Trident HA cupTritanium cup

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a BMI \< 35
  • Patients requiring uncemented primary THA
  • Primary diagnosis of osteoarthritis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht UMC

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Lodewijk Van Rhijn, professor

    Maastricht University Medical centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rene ten Broeke, MD

CONTACT

+31 43 387 5038r.ten.broeke@mumc.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2012

First Posted

June 13, 2012

Study Start

November 1, 2011

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

NL(1)