Comparison of the in Vivo Stability of 2 Cementless TKA Designs

Knee Osteoarthritis Clinical Trial

— ClessTKA  

Official title:

Comparison of the in Vivo Stability of 2 Cementless TKA Designs Using CT Micromotion Analysis - A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651009
• Other study ID #: 520246
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2022
• Est. completion date: January 1, 2033

Study information

• Verified date: December 2023
• Source: Helse Møre og Romsdal HF
• Contact: Frank-David Øhrn, MD, PhD
• Phone: 71120000
• Email: frank-david.ohrn[@]helse-mr.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2033
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• TKA
Total knee artroplasty with medial parapatellar incision and mechanical alignment without navigation

Locations

Country	Name	City	State
Norway	Kristiansund Hospital, Møre and Romsdal Hospital Trust	Kristiansund	Møre And Romsdal

Sponsors (3)

Lead Sponsor	Collaborator
Helse Møre og Romsdal HF	Medacta International SA, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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).

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BMI	Body mass index (kg/m2)	Preoperative
Other	Operation time	Time used in minutes from skin incision to wound closure.	Intraoperative
Other	Axial alignment of the tibia	Measured by Bergers method (degrees internal or extarnal rotation)	Up to 1 week postoperative
Primary	CTMA Maximum Total Translation	The highest total translation on the implant at each time point	Up to 2 years
Primary	CTMA Maximum Total Translation	The highest total translation on the implant at each time point	Up to 5 years
Secondary	CTMA Total rotation	Center of mass and peripheral points (degrees)	Up to 2 years
Secondary	CTMA Total rotation	Center of mass and peripheral points (degrees)	Up to 5 years
Secondary	CTMA Total translation	Center of mass and peripheral points (millimeters)	Up to 2 years
Secondary	CTMA Total translation	Center of mass and peripheral points (millimeters)	Up to 5 years
Secondary	The Forgotten Joint Score (FJS)	Patient Reported Outcome Measure PROMs). 12 item likert scale with scores from 0-4 (0=never, 4= allways). Mean value is multiplied with 25 and the subtracted from 100. Maximum score i 100 (excellent), minimum score is 0 (worse).	Up to 2 years
Secondary	The Forgotten Joint Score (FJS)	Patient Reported Outcome Measure PROMs). 12 item likert scale with scores from 0-4 (0=never, 4= allways). Mean value is multiplied with 25 and the subtracted from 100. Maximum score i 100 (excellent), minimum score is 0 (worse).	Up to 5 years
Secondary	The Knee injury and Osteoarthritis Outcome Score (KOOS)	Patient Reported Outcome Measure (PROMs). KOOS consists of 5 subscales; Pain, other Symptoms, Activites of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and knee-related Quality of Life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale	Up to 2 years
Secondary	The Knee injury and Osteoarthritis Outcome Score (KOOS)	Patient Reported Outcome Measure (PROMs). KOOS consists of 5 subscales; Pain, other Symptoms, Activites of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and knee-related Quality of Life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale	Up to 5 years
Secondary	Range of motion	From full extension to full flexion (degrees)	Up to 2 years
Secondary	Range of motion	From full extension to full flexion (degrees)	Up to 5 years
Secondary	HKA	Hip knee ankle angle measured on X-ray (degrees). Deviation from 0 is either varus (-) or valgus (+)	Up to 2 years
Secondary	HKA	Hip knee ankle angle measured on X-ray (degrees). Deviation from 0 is either varus (-) or valgus (+)	Up to 5 years