Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study (HLS)

Civil Hospices of Lyon

Status and phase: Withdrawn; Phase 4

Conditions: Total Knee Arthroplasty

Treatments: Device: Surgical total knee replacement using uncemented components; Device: Surgical total knee replacement using cemented components

Study type: Interventional

Funder types: Other

Identifiers

NCT02355652

2014.883

Details and patient eligibility

About

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.

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Cemented TKA

Active Comparator group

Treatment:

Device: Surgical total knee replacement using cemented components

Uncemented TKA

Active Comparator group

Treatment:

Device: Surgical total knee replacement using uncemented components