Finnish Unicompartmental and Total Knee Arthroplasty Investigation

Summary

Unicondylar knee arthroplasty (UKA) can be used as the treatment of knee OA isolated to a single compartment instead of TKA. Both UKA and TKA have been used for decades as a treatment of knee OA. However, operative indications for TKA and UKA overlaps, but they are not similar. Therefore, the outcome or survivorship of these procedures cannot be compared directly.

Some advantages of UKA over TKA have been reported, including faster recovery time, reduced perioperative morbidity and mortality, a subjective preference of feeling more normal knee, lower cost and improved return to work and sport. On the other side national arthroplasty registers consistently report around a threefold increase in crude cumulative revision rate at 8 to 10 years for UKA compared with TKA 7-10.

The aim of this study is to compare functional, clinical, patient satisfaction, and implant survival results of cementless UKA with those of cemented TKA at 2 months, 1, 2, 5 and 10 years after the procedure. The study design is a multicenter, double-blind and randomized trial of knee replacement patients. The primary outcome is the Oxford Knee Score (OKS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 year.

Conditions

• Osteoarthritis, Knee

Interventions

PROCEDURE

Unicondylar Knee Replacement

UKA involves only the replacement of affected medial compartment. In the study, the operation will be performed through standard medial parapatellar incision with midline skin incision, but the knee joint and fascia will be opened like in standard Oxford minimally invasive incision. The procedure will be performed by using Oxford Microplasty instrumentation and following Microplasty surgical technique (Biomet Orthopedics). Intraoperative local infiltration analgesia is used for postoperative pain management. Drain is not used.

PROCEDURE

Total Knee Replacement

TKA is performed through a standard medial parapatellar incision, which provides easy access to the knee joint. Skin incision is done to midline. Intramedullary guide is used for alignment of femoral and tibia saw cuts and component positions. Components will be cemented in position. The patella will not be resurfaced. Intraoperative local infiltration analgesia (LIA) is used for postoperative pain management. Drain is not used.

Sponsors & Collaborators

• Turku University Hospital

  lead OTHER_GOV

Principal Investigators

• Tuukka Niinimäki, MD PhD · Oulu University Hospital

• Heikki Nurmi, MD · Central Finland Central Hospital

• Alar Toom, MD PhD · Central Finland Central Hospital

• Jani Knifsund, MD · Turku University Hospital

• Keijo Mäkelä, Adj. Prof. · Turku University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2018-06-30

Completion

2027-08-31

Countries

• Finland

Study Locations