The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

L

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

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

Trial contacts and locations

0

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Central trial contact

Yasser Rehman, MD

Data sourced from clinicaltrials.gov

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