The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

Degenerative Joint Disease of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03059927
• Other study ID #: LovisenbergOrto
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2017
• Last updated: April 19, 2017
• Start date: March 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2017
• Source: Lovisenberg Diakonale Hospital
• Contact: Yasser Rehman, MD
• Phone: +4798477583
• Email: yare[@]lds.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Joint Disease of Knee
• Gonarthrosis; Primary
• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Knee arthroplasty, Cruciate retaining
Legion total knee arthroplasty implant component, Smith & Nephew, Cruciate Retaining design
• Knee arthroplasty, Anterior stabilized
Legion total knee arthroplasty implant component, Smith & Nephew, Anterior Stabilized design
• Knee arthroplasty, Posterior stabilized
Legion total knee arthroplasty implant component, Smith & Nephew, Posterior Stabilized design

Locations

Country	Name	City	State
Norway	Haugesund Rheumatism Hospital	Haugesund
Norway	Lovisenberg Diaconal Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital	Haugesund Rheumatism Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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