Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study (HLS)
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|ClinicalTrials.gov Identifier: NCT02355652|
Recruitment Status : Withdrawn (an other study will start with new outcome measures)
First Posted : February 4, 2015
Last Update Posted : January 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Total Knee Arthroplasty||Device: Surgical total knee replacement using cemented components Device: Surgical total knee replacement using uncemented components||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||March 2017|
|Active Comparator: Cemented TKA||
Device: Surgical total knee replacement using cemented components
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.
|Active Comparator: Uncemented TKA||
Device: Surgical total knee replacement using uncemented 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.
- IKS 2011 Score measuring the clinical results of TKA [ Time Frame: One year postoperative ]IKS 2011 Score will be assessed for each patients and the mean IKS Score will be compared between both arms
- Number of patients in each arm with radiological loosening signs of the TKA components [ Time Frame: One year postoperative ]At one year postoperative, each patient will go under standard radiological exam seeking for signs of loosening of the prosthetic components. The number of patients presenting radiological signs of loosening will be compared between both arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355652
|Hôpital de la Croix-Rousse|
|Lyon, France, 69004|
|Principal Investigator:||Philippe NEYRET, Pr||Hospices Civils de Lyon|