The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Gonarthrosis; Primary; Degenerative Joint Disease of Knee
• Intervention / Treatment: Procedure: Knee arthroplasty, Cruciate retaining; Procedure: Knee arthroplasty, Anterior stabilized; Procedure: Knee arthroplasty, Posterior stabilized

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 Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasser Rehman, MD; Phone Number: +4798477583; Email: yare@lds.no

Study Locations

• Norway
  • Haugesund, Norway, 5528
    • Not yet recruiting
    • Haugesund Rheumatism Hospital
    • Contact: Øystein Gøthesen, Md, PhD; Phone Number: 988 08162
  • Oslo, Norway, 0446
    • Recruiting
    • Lovisenberg Diaconal Hospital
    • Contact: Arild Aamodt, MD, PhD; Email: aara@lds.no
    • Principal Investigator: Yasser Rehman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Knee arthroplasty, Cruciate retaining; Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert.	Procedure: Knee arthroplasty, Cruciate retaining; Legion total knee arthroplasty implant component, Smith & Nephew, Cruciate Retaining design
Active Comparator: Knee arthroplasty, Anterior stabilized; Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert.	Procedure: Knee arthroplasty, Anterior stabilized; Legion total knee arthroplasty implant component, Smith & Nephew, Anterior Stabilized design
Active Comparator: Knee arthroplasty, Posterior stabilized; Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design.	Procedure: Knee arthroplasty, Posterior stabilized; Legion total knee arthroplasty implant component, Smith & Nephew, Posterior Stabilized design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee injury and osteoarthritis outcome score (KOOS)	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.	Pre-operative, 1, 2 and 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford knee score (OKS)	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.	Pre-operative, 1, 2 and 5 years
EQ-5D-5L	EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life	Pre-operative, 1, 2 and 5 years
Range of motion (ROM)	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	Pre-operative, 6 weeks, 3, 12, 24 and 60 months
Kinematic radiostereometric analysis (RSA)	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.	After 12 months
Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs	Radiographs obtained for assessment of fixation of the prosthesis and the alignment.	Pre-operative, 3, 12, 24 and 60 months
Brief Pain Inventory	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.	Pre-operative, 6 weeks, 3, 12, 24 and 60 months

Collaborators and Investigators

• Sponsor: Lovisenberg Diakonale Hospital
• Collaborators: Haugesund Rheumatism Hospital
• Investigators: Study Director: Arild Aamodt, MD, PhD, Lovisenberg Diaconal Hospital, Oslo, Norway

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Cruciate retaining; Anterior stabilized; Posterior stabilized; Posterior cruciate ligament; Degenerative knee joint disease; Knee injury and Osteoarthritis Outcome Score; Kinematic radiostereometry
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
• Other Study ID Numbers: LovisenbergOrto

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No