NCT00132587

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 28, 2019

Status Verified

June 1, 2008

Enrollment Period

2.8 years

First QC Date

August 19, 2005

Last Update Submit

May 23, 2019

Conditions

Osteoarthritis, Knee

Keywords

Knee arthroplastyFemoral looseningTotal Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • IKS (International Knee Society) score at 12 months

Secondary Outcomes (1)

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

Interventions

cement Palacos R40 and LV40DEVICE

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Croix-Rousse

Lyon, 69317, France

Location

Related Publications (1)

  • 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.

    PMID: 20194310RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Philippe NEYRET, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 22, 2005

Study Start

March 1, 2004

Primary Completion

December 1, 2006

Study Completion

March 1, 2007

Last Updated

May 28, 2019

Record last verified: 2008-06

Locations

FR(1)