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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Recruitment Status : Withdrawn (an other study will start with new outcome measures)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
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Knee osteoarthritis
  • Need for a total knee arthroplasty

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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France
Hôpital de la Croix-Rousse
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Philippe NEYRET, Pr Hospices Civils de Lyon

Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02355652     History of Changes
Other Study ID Numbers: 2014.883
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017

Keywords provided by Hospices Civils de Lyon:
Total knee arthroplasty
IKS Score
cemented, uncemented