Randomised Controlled Trial PFC Versus CKS Total Knee Pro... | NCT00228137

Studies
Randomised Controlled Trial PFC Versus CKS Total Knee Prostheses

NCT00228137

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Aug 9, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Osteoarthritis, Knee

Interventions

Not provided

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
FBW STRATEC 96856

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

Not provided

Completion Date

Nov 2012Estimated

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 27, 2005

First Posted Date

Sep 28, 2005Estimated

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

Aug 8, 2007

Last Update Posted Date

Aug 9, 2007Estimated

Description Module

Brief Summary

The purpose of this study is to compare the functional outcome of two different total knee prostheses in a prospective randomised study.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients on the waiting list for a TKA due to an invalidating gonarthrose as a result of osteo-arthrosis or secondary to a rheumatic disease or a trauma.

Exclusion Criteria:

patient suffering from juvenile rheumatic disease
patient suffering hemophilia
patient on the waiting list for posterior stabilized TKA or hinge joint.
patient who suffers from a lesion of the ligaments due to surgery
patient who is legally not capable to make decisions
patient who suffer from cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maarten MC de Waal Malefijt, MD	Radboud University Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMC Radboud		Nijmegen		6500 HB	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22066559	Derived	Meijerink HJ, Verdonschot N, van Loon CJ, Hannink G, de Waalmalefijt MC. Similar TKA designs with differences in clinical outcome: a randomized, controlled trial of 77 knees with a mean follow-up of 6 years. Acta Orthop. 2011 Dec;82(6):685-91. doi: 10.3109/17453674.2011.636677. Epub 2011 Nov 9.

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases