Clinical trial NCT03059927: The Effect of Three Prosthesis Designs in Total Knee Arthroplasty
Official title: The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gonarthrosis; Primary
Degenerative Joint Disease of Knee
Keywords: Cruciate retaining
Anterior stabilized
Posterior stabilized
Posterior cruciate ligament
Degenerative knee joint disease
Knee injury and Osteoarthritis Outcome Score
Kinematic radiostereometry
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: Haugesund Rheumatism Hospital
First posted: 2017-02-23
Enrollment: 216
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: Pre-operative, 1, 2 and 5 years
Secondary outcomes:
measure: Oxford knee score (OKS)
timeFrame: Pre-operative, 1, 2 and 5 years
measure: EQ-5D-5L
timeFrame: Pre-operative, 1, 2 and 5 years
measure: Range of motion (ROM)
timeFrame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months
measure: Kinematic radiostereometric analysis (RSA)
timeFrame: After 12 months
measure: Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs
timeFrame: Pre-operative, 3, 12, 24 and 60 months
measure: Brief Pain Inventory
timeFrame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months
Other outcomes:
Locations:
city: Haugesund
country: Norway
facility: Haugesund Rheumatism Hospital
city: Oslo
country: Norway
facility: Lovisenberg Diaconal Hospital
Study officials:
affiliation: Lovisenberg Diaconal Hospital, Oslo, Norway
name: Arild Aamodt, MD, PhD
role: STUDY_DIRECTOR
References: