The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

Lovisenberg Diakonale Hospital

Status: Enrolling

Conditions: Degenerative Joint Disease of Knee; Gonarthrosis; Primary

Treatments: Procedure: Knee arthroplasty, Anterior stabilized; Procedure: Knee arthroplasty, Posterior stabilized; Procedure: Knee arthroplasty, Cruciate retaining

Study type: Interventional

Funder types: Other

Identifiers

NCT03059927

LovisenbergOrto

Details and patient eligibility

About

The purpose of this study is to compare three prosthesis designs to compare three prosthesis designs for total knee arthroplasty and determine the best option for patients in need of a knee replacement.

Full description

Total knee arthroplasty (TKA) is a cost beneficial surgery shown to improve pain, function and quality of life in patients with osteoarthritis. In 2015, 6093 patients received primary TKA in Norway. Despite the procedure´s general success, 20% of patients report persistent postoperative pain and/or dissatisfaction with the surgical outcome. Efforts to further improve the procedure have raised considerable debate regarding the role and management of the posterior cruciate ligament (PCL). Prostheses for TKA have evolved into designs that either preserve or sacrifice the PCL. In patients with a functional PCL, the decision of which design is selected depends largely on the favor and training of the surgeon. To further improve TKA patient outcomes, a better understanding of the role of these differing PCL treatments is needed. Thus, the aim of this study is to determine whether patients' perceived outcome, implant stability and clinical outcome differ between 3 TKA implant designs (2 PCL-sacrificing and 1 PCL-retaining). We will conduct a 3-arm randomized controlled prospective trial with 5-year follow-up. This study will have impact on clinical practice by addressing the lack of evidence supporting use of these different types of implants.

Enrollment: 216 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary osteoarthritis
• Non-fixed or fixed varus or valgus deformity less than 15º measured on preoperative standing hip-knee-ankle (HKA) radiographs
• Intact PCL (assessed preoperatively and verified during surgery)
• Age 45 - 75 years (only patients 45 - 70 years will be included in the kinematic RSA)
• Body mass index ≤ 35 kg/m2
• ASA (American Society of Anaesthesiologists) score I or II
• Only patients with KOOS scores above 80 on the Symptoms, ADL (Activities of Daily Living) and Pain subscales will be included in the kinematic analysis

Exclusion criteria

• Prior ACL (anterior cruciate ligament) surgery
• Impaired collateral ligaments
• Secondary osteoarthritis of the knee
• Previous osteotomy
• Rheumatic disease
• Flexion less than 90 degrees
• Flexion contracture over 10 degrees
• Peripheral neuropathy
• Malignancy
• Patients who do not speak Norwegian

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 3 patient groups

Knee arthroplasty, Cruciate retaining

Active Comparator group

Description:

Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert.

Treatment:

Procedure: Knee arthroplasty, Cruciate retaining

Knee arthroplasty, Anterior stabilized

Active Comparator group

Description:

Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert.

Treatment:

Procedure: Knee arthroplasty, Anterior stabilized

Knee arthroplasty, Posterior stabilized

Active Comparator group

Description:

Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design.

Treatment:

Procedure: Knee arthroplasty, Posterior stabilized