Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02355652

Acronym

HLS

Enrollment

Registered

2015-02-04

Start date

2015-01-31

Completion date

2017-03-31

Last updated

2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

Keywords

Total knee arthroplasty, IKS Score, cemented, uncemented

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.

Interventions

DEVICESurgical 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.

DEVICESurgical 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
IKS 2011 Score measuring the clinical results of TKA	One year postoperative	IKS 2011 Score will be assessed for each patients and the mean IKS Score will be compared between both arms

Secondary

Measure	Time frame	Description
Number of patients in each arm with radiological loosening signs of the TKA components	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026