Comparison of the in Vivo Stability of 2 Cementless TKA Designs

NCT05651009 | Active Not Recruiting

• 1 other identifier: 520246
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

CT based micromotion analysis; CTMA; Cementless TKA; Uncemented TKA; Total knee replacement; Total knee arthroplasty; TKR; GMK Sphere; Tritanium

Outcome Measures

Primary Outcomes (2)

• CTMA Maximum Total Translation

  The highest total translation on the implant at each time point

  Up to 2 years

• CTMA Maximum Total Translation

  The highest total translation on the implant at each time point

  Up to 5 years

Secondary Outcomes (12)

• CTMA Total rotation

  Up to 2 years

• CTMA Total rotation

  Up to 5 years

• CTMA Total translation

  Up to 2 years

• CTMA Total translation

  Up to 5 years

• The Forgotten Joint Score (FJS)

  Up to 2 years

Other Outcomes (3)

• BMI

  Preoperative

• Operation time

  Intraoperative

• Axial alignment of the tibia

  Up to 1 week postoperative

Study Arms (2)

Control group

EXPERIMENTAL

Cementless Triathlon Tritanium 3D printed TKA

Procedure: TKA

Study group

EXPERIMENTAL

GMK Sphere cementless 3D printed TKA

Procedure: TKA

Interventions

TKA PROCEDURE

Total knee artroplasty with medial parapatellar incision and mechanical alignment without navigation

Control group; Study group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• Oslo University Hospital: collaborator
• Medacta International SA: collaborator

Study Sites (1)

Kristiansund Hospital, Møre and Romsdal Hospital Trust

Kristiansund, Møre and Romsdal, 6508, Norway

Location

Related Publications (7)

• 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.

  PMID: 16826107 BACKGROUND

• 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.

  PMID: 29232186 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 30368560 BACKGROUND

• 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.

  PMID: 35809105 BACKGROUND

• 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.

  PMID: 33821746 BACKGROUND

• 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.

  PMID: 27478832 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Frank-David Øhrn, MD, PhD

  Møre og Romsdal Hospital Trust

  STUDY DIRECTOR

• Stephan M Röhrl, MD, PhD

  Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double blinded study (patient and research nurse)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 14, 2022
• Study Start: December 6, 2022
• Primary Completion (Estimated): June 25, 2028
• Study Completion (Estimated): January 1, 2033
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Immediately following publication and 5 years
• Access Criteria: Researchers that want access to data

Locations

NO (1)