Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study

Total Knee Arthroplasty Clinical Trial

— HLS  

Official title:

Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02355652
• Other study ID #: 2014.883
• Status: Withdrawn
• Phase: Phase 4
• First received: January 26, 2015
• Last updated: January 5, 2017
• Start date: January 2015
• Est. completion date: March 2017

Study information

• Verified date: January 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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.
• 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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of patients in each arm with radiological loosening signs of the TKA components	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.	One year postoperative	No

External Links

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