Total Knee Arthroplasty (TKA) Cemented Versus Cementless | NCT00132587

Studies
Total Knee Arthroplasty (TKA) Cemented Versus Cementless

NCT00132587

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

May 28, 2019Actual

Enrollment

130

Phase

Not Applicable

Conditions

Osteoarthritis, Knee

Interventions

cement Palacos R40 and LV40

Countries

France

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

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Dec 2006Actual

Completion Date

Mar 2007Actual

First Submitted Date

Aug 19, 2005

First Submission Date that Met QC Criteria

Aug 19, 2005

First Posted Date

Aug 22, 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

May 23, 2019

Last Update Posted Date

May 28, 2019Actual

Description Module

Brief Summary

The aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement.

One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. The study criteria include the IKS (International Knee Society) score and the analysis of a radiolucent line at the femur.

Patients will be reviewed at 2, 6 and 12 months.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130

Name	Type	Description	Arm Group Labels	Other Names
cement Palacos R40 and LV40	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IKS (International Knee Society) score at 12 months

Secondary Outcomes

Measure	Description	Time Frame
Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Osteoarthritis (medial and/or lateral femoro-tibial arthritis and/or patellofemoral arthritis)
Indication of surgical treatment by total knee arthroplasty
Age between 50 and 90 years
Acceptance and signature to participate

Exclusion Criteria:

Rheumatoid or other inflammatory arthritis
Association with other surgical procedure (osteotomy)
Range of motion inferior to 90°
Previous knee surgery (except arthroscopy)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe NEYRET, MD	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital de la Croix-Rousse		Lyon		69317	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20194310	Result	Demey G, Servien E, Pinaroli A, Lustig S, Ait Si Selmi T, Neyret P. The influence of femoral cementing on perioperative blood loss in total knee arthroplasty: a prospective randomized study. J Bone Joint Surg Am. 2010 Mar;92(3):536-41. doi: 10.2106/JBJS.H.01159.

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