Total Knee Arthroplasty (TKA) Cemented Versus Cementless

Osteoarthritis, Knee Clinical Trial

Official title:

Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132587
• Other study ID #: 2003.313
• Status: Completed
• Phase: N/A
• Start date: March 2004
• Est. completion date: March 2007

Study information

• Verified date: June 2008
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• cement Palacos R40 and LV40

Locations

Country	Name	City	State
France	Hôpital de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Demey G, Servien E, Pinaroli A, Lustig S, Aït 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IKS (International Knee Society) score at 12 months
Secondary	Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months