The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

Not Applicable

• Conditions: Gonarthrosis; Primary; Degenerative Joint Disease of Knee
• Interventions: Procedure: Knee arthroplasty, Posterior stabilized; Procedure: Knee arthroplasty, Anterior stabilized; Procedure: Knee arthroplasty, Cruciate retaining

• Registration Number: NCT03059927
• Lead Sponsor: Lovisenberg Diakonale Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Study Start: 2017-03-01
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Knee arthroplasty, Posterior stabilized	Knee arthroplasty, Posterior stabilized	Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design.
Knee arthroplasty, Anterior stabilized	Knee arthroplasty, Anterior stabilized	Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert.
Knee arthroplasty, Cruciate retaining	Knee arthroplasty, Cruciate retaining	Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert.

Primary Outcome Measures

Name	Time	Method
Knee injury and osteoarthritis outcome score (KOOS)	Pre-operative, 1, 2 and 5 years	KOOS is a knee-specific questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire.

Secondary Outcome Measures

Name	Time	Method
Kinematic radiostereometric analysis (RSA)	After 12 months	Knee motion while walking up and down stairs, and during squatting and kneeling activities will be recorded using video fluoroscopy (dynamic RSA) at 12 months.
Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs	Pre-operative, 3, 12, 24 and 60 months	Radiographs obtained for assessment of fixation of the prosthesis and the alignment.
Brief Pain Inventory	Pre-operative, 6 weeks, 3, 12, 24 and 60 months	We will use three single items to measure worst pain intensity, average pain intensity, and pain interference with walking. Patients rate their pain intensity and pain interference with walking on an 11-point numeric rating scale from 0-10, where 0=no pain/no interference and 10=worst imaginable pain/complete interference.
Oxford knee score (OKS)	Pre-operative, 1, 2 and 5 years	OKS is a brief patient-completed questionnaire for patients undergoing total knee arthroplasty. It reflects the patient's assessment of their knee-related health status and benefits of treatment.
EQ-5D-5L	Pre-operative, 1, 2 and 5 years	EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life
Range of motion (ROM)	Pre-operative, 6 weeks, 3, 12, 24 and 60 months	ROM will be measured by extension and flexion with a goniometer preoperatively at baseline and at each follow-up visit (6 weeks, 3 months, 12 months, 24 months and 60 months

Trial Locations

Locations (2)

Haugesund Rheumatism Hospital; 🇳🇴 Haugesund, Norway

Lovisenberg Diaconal Hospital; 🇳🇴 Oslo, Norway