The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

NCT ID: NCT03059927

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2023-12-31

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.

Conditions

Gonarthrosis; Primary; Degenerative Joint Disease of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Knee arthroplasty, Cruciate retaining

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

Group Type: ACTIVE_COMPARATOR

Knee arthroplasty, Cruciate retaining

Intervention Type: PROCEDURE

Legion total knee arthroplasty implant component, Smith \& Nephew, Cruciate Retaining design

Knee arthroplasty, Anterior stabilized

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

Group Type: ACTIVE_COMPARATOR

Knee arthroplasty, Anterior stabilized

Intervention Type: PROCEDURE

Legion total knee arthroplasty implant component, Smith \& Nephew, Anterior Stabilized design

Knee arthroplasty, Posterior stabilized

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

Group Type: ACTIVE_COMPARATOR

Knee arthroplasty, Posterior stabilized

Intervention Type: PROCEDURE

Legion total knee arthroplasty implant component, Smith \& Nephew, Posterior Stabilized design

Interventions

Knee arthroplasty, Cruciate retaining

Legion total knee arthroplasty implant component, Smith \& Nephew, Cruciate Retaining design

Intervention Type: PROCEDURE

Knee arthroplasty, Anterior stabilized

Legion total knee arthroplasty implant component, Smith \& Nephew, Anterior Stabilized design

Intervention Type: PROCEDURE

Knee arthroplasty, Posterior stabilized

Legion total knee arthroplasty implant component, Smith \& Nephew, Posterior Stabilized design

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haugesund Rheumatism Hospital

OTHER

Sponsor Role: collaborator

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arild Aamodt, MD, PhD

Role: STUDY_DIRECTOR

Lovisenberg Diaconal Hospital, Oslo, Norway

Locations

Haugesund Rheumatism Hospital

Haugesund, , Norway

Site Status: NOT_YET_RECRUITING

Lovisenberg Diaconal Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Yasser Rehman, MD

Role: CONTACT

yare@lds.no

+4798477583

Facility Contacts

Øystein Gøthesen, Md, PhD

Role: primary

988 08162

Arild Aamodt, MD, PhD

Role: primary

aara@lds.no

Other Identifiers

LovisenbergOrto

Identifier Type: -

Identifier Source: org_study_id