RSA Study Using Two Types of Uncemented Acetabular Compon... | NCT01618084

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

NCT01618084

Sponsor

Maastricht University Medical Center

Status

Unknown status

Last Update Posted

Jun 13, 2012Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Osteoarthritis

Interventions

Tritanium acetabular component

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NL 33832.068.10	Other Identifier	CCMO

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

May 22, 2012

First Submission Date that Met QC Criteria

Jun 11, 2012

First Posted Date

Jun 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2012

Last Update Posted Date

Jun 13, 2012Estimated

Name	Class
Stryker Orthopaedics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tritanium cup	Experimental		Device: Tritanium acetabular component
Trident HA cup	Active Comparator		Device: Tritanium acetabular component

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tritanium acetabular component	Device	Total hip arthroplasty using a tritanium uncemented acetabular component	Trident HA cup Tritanium cup

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rene ten Broeke, MD	Contact	+31 43 387 5038		r.ten.broeke@mumc.nl

Overall Officials

Name	Affiliation	Role
Lodewijk Van Rhijn, professor	Maastricht University Medical centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht UMC	Recruiting	Maastricht			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided