Study Stopped
an other study will start with new outcome measures
Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study
HLS
Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA). Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA. The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative. The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2015
Typical duration for phase_4
1 active site
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
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 26, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJanuary 6, 2017
January 1, 2017
2 years
January 26, 2015
January 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IKS 2011 Score measuring the clinical results of TKA
IKS 2011 Score will be assessed for each patients and the mean IKS Score will be compared between both arms
One year postoperative
Secondary Outcomes (1)
Number of patients in each arm with radiological loosening signs of the TKA components
One year postoperative
Study Arms (2)
Cemented TKA
ACTIVE COMPARATORUncemented TKA
ACTIVE COMPARATORInterventions
Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using cemented femoral and tibial prosthetic components.
Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using uncemented femoral and tibial prosthetic components.
Eligibility Criteria
You may qualify if:
- Knee osteoarthritis
- Need for a total knee arthroplasty
You may not qualify if:
- Age \< 50 or \> 80
- Need for a different procedure than a TKA
- Preoperative knee flexion \< 90°
- Need for a TKA associated with a combined femoral or tibial osteotomy
- Knee already operated except for arthroscopy
- Mediocre bone quality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital de la Croix-Rousse
Lyon, 69004, France
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe NEYRET, Pr
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2015
First Posted
February 4, 2015
Study Start
January 1, 2015
Primary Completion
January 1, 2017
Study Completion
March 1, 2017
Last Updated
January 6, 2017
Record last verified: 2017-01