Clinical trial NCT05651009: Comparison of the in Vivo Stability of 2 Cementless TKA Designs
Official title: Comparison of the in Vivo Stability of 2 Cementless TKA Designs Using CT Micromotion Analysis - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: CT based micromotion analysis
CTMA
Cementless TKA
Uncemented TKA
Total knee replacement
Total knee arthroplasty
TKR
GMK Sphere
Tritanium
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
name: Medacta International SA
First posted: 2022-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to analyze the stability of a cementless Total Knee Arthroplasty (TKA) over time and compare it to a well-documented implant in patients with knee osteoarthritis. The main aim is to answer if there is a difference in stability over time as a measure of long time survivorship in these 2 implants.

50 participants will be randomly allocated to receive either the Triathlon Tritanium (Stryker) or the Global Medacta Knee Sphere (GMK Sphere, Medacta) 3D printed cementless TKAs.

Detailed description: Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both TKA and Total Hip Artrhoplasties (THA) have excellent implant survivorship. However, patients' satisfaction is lower in TKA than THA. A possible cause of the discrepancy is the unnatural knee kinematics after TKA. Various implants designs have been developed to solve the problem. The most common fixation mode is cemented TKA with good survival up to 15 years. However, newer series in younger patients also have shown lasting survival with cementless implants (Nilsson KG, Prudhon JL). Among various different designs, the medially stabilized total knee, which are designed to reproduce natural knee kinematics with a medial ball-in-socked design, is a promising implant design (No authors listed). Dynamically the medial pivot knee performs more naturally (Bragonzoni L,Petersen ET) compared to other designs. Most data for this design is available only for the cemented version. Up to now there is no safety study performed that confirms the stability over time for this implant with cementless fixation.

In this study, the investigators will therefore analyze the in vivo stability of an uncemented TKA with a medially stabilized design, and compare it with a well-documented comparable implant. In order to do this, the investigators will use the CT based micromotion analysis (Broden C, Broden C). This study will contribute to the understanding of fixation and lead to safety to the patient.

Eligibility criteria: Inclusion Criteria:

• Patients referred to Kristiansund Hospital for primary total knee replacement surgery for osteoarthritis with Kellgren \& Lawrence grade 3 or 4

Exclusion Criteria:

* Preoperative severe deformity (Hip-Knee-Ankle angle of \>5 (valgus) or \<-15 degrees (varus) on a full-length leg image at weight bearing
* Preoperative flexion contracture more than 15°
* Less than 50 and more than 75 years of age at the time of surgery
* Use of walking aids because of other musculoskeletal and neuromuscular problems
* Preoperative diagnosis other than osteoarthritis or avascular necrosis (e.g. rheumatoid arthritis, tumours)
* Revision arthroplasty
* Obesity with BMI\>35 g/m2
* Lateral collateral ligament deficient knee
* Previous knee joint infection
* Cognitive dysfunction or severe psychiatric disorders.

Primary outcomes:
measure: CTMA Maximum Total Translation
timeFrame: Up to 2 years
measure: CTMA Maximum Total Translation
timeFrame: Up to 5 years
Secondary outcomes:
measure: CTMA Total rotation
timeFrame: Up to 2 years
measure: CTMA Total rotation
timeFrame: Up to 5 years
measure: CTMA Total translation
timeFrame: Up to 2 years
measure: CTMA Total translation
timeFrame: Up to 5 years
measure: The Forgotten Joint Score (FJS)
timeFrame: Up to 2 years
measure: The Forgotten Joint Score (FJS)
timeFrame: Up to 5 years
measure: The Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Up to 2 years
measure: The Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Up to 5 years
measure: Range of motion
timeFrame: Up to 2 years
measure: Range of motion
timeFrame: Up to 5 years
measure: HKA
timeFrame: Up to 2 years
measure: HKA
timeFrame: Up to 5 years
Other outcomes:
measure: BMI
timeFrame: Preoperative
measure: Operation time
timeFrame: Intraoperative
measure: Axial alignment of the tibia
timeFrame: Up to 1 week postoperative
Locations:
city: Kristiansund
country: Norway
facility: Kristiansund Hospital, Møre and Romsdal Hospital Trust
state: Møre And Romsdal
Study officials:
affiliation: Møre og Romsdal Hospital Trust
name: Frank-David Øhrn, MD, PhD
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Stephan M Röhrl, MD, PhD
role: STUDY_CHAIR
References:
citation: Nilsson KG, Henricson A, Norgren B, Dalen T. Uncemented HA-coated implant is the optimum fixation for TKA in the young patient. Clin Orthop Relat Res. 2006 Jul;448:129-39. doi: 10.1097/01.blo.0000224003.33260.74.
citation: Prudhon JL, Verdier R. Cemented or cementless total knee arthroplasty? - Comparative results of 200 cases at a minimum follow-up of 11 years. SICOT J. 2017;3:70. doi: 10.1051/sicotj/2017046. Epub 2017 Dec 12.
citation: No authors listed. Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hip, Knee & Shoulder Arthroplasty: 2020 Annual Report, Adelaide; AOA, 2021: https://aoanjrr.sahmri.com/documents/10180/712282/Hip%2C+Knee+%26+Shoulder+Arthroplasty/bb011aed-ca6c-2c5e-f1e1-39b4150bc693 (date assessed October 29 2022).
citation: Bragonzoni L, Marcheggiani Muccioli GM, Bontempi M, Roberti di Sarsina T, Cardinale U, Alesi D, Iacono F, Neri MP, Zaffagnini S. New design total knee arthroplasty shows medial pivoting movement under weight-bearing conditions. Knee Surg Sports Traumatol Arthrosc. 2019 Apr;27(4):1049-1056. doi: 10.1007/s00167-018-5243-5. Epub 2018 Oct 27.
citation: Petersen ET, Rytter S, Koppens D, Dalsgaard J, Hansen TB, Andersen MS, Stilling M. Medial congruent polyethylene design show different tibiofemoral kinematics and enhanced congruency compared to a standard symmetrical cruciate retaining design for total knee arthroplasty-an in vivo randomized controlled study of gait using dynamic radiostereometry. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):933-945. doi: 10.1007/s00167-022-07036-w. Epub 2022 Jul 9.
citation: Broden C, Sandberg O, Olivecrona H, Emery R, Skoldenberg O. Precision of CT-based micromotion analysis is comparable to radiostereometry for early migration measurements in cemented acetabular cups. Acta Orthop. 2021 Aug;92(4):419-423. doi: 10.1080/17453674.2021.1906082. Epub 2021 Apr 6.
citation: Broden C, Olivecrona H, Maguire GQ Jr, Noz ME, Zeleznik MP, Skoldenberg O. Accuracy and Precision of Three-Dimensional Low Dose CT Compared to Standard RSA in Acetabular Cups: An Experimental Study. Biomed Res Int. 2016;2016:5909741. doi: 10.1155/2016/5909741. Epub 2016 Jul 10.