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Knee OsteoarthritisClessTKANCT05651009

Comparison of the in Vivo Stability of 2 Cementless TKA Designs

A study testing TKA in people with Knee Osteoarthritis, run by Helse Møre og Romsdal HF at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
TKA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteNorway
Study dates
6 Dec 2022to 1 Jan 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • Obesity with BMI>35 g/m2
  • Lateral collateral ligament deficient knee
  • Previous knee joint infection
  • Cognitive dysfunction or severe psychiatric disorders.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Kristiansund Hospital, Møre and Romsdal Hospital Trust

    Kristiansund, Møre and Romsdal, 6508

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
TKA
Keywords
CT based micromotion analysis, CTMA, Cementless TKA, Uncemented TKA, Total knee replacement, Total knee arthroplasty, TKR, GMK Sphere, Tritanium
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TKAProcedure or surgery

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

Study groups in NCT05651009
Study groupRoleWhat they receive
Control groupExperimentalCementless Triathlon Tritanium 3D printed TKA
Receives: Procedure: TKA
Study groupExperimentalGMK Sphere cementless 3D printed TKA
Receives: Procedure: TKA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CTMA Maximum Total Translation

    The highest total translation on the implant at each time point

    Measured: Up to 2 years

  2. CTMA Maximum Total Translation

    The highest total translation on the implant at each time point

    Measured: Up to 5 years

Secondary outcomes (12)

  1. CTMA Total rotation

    Center of mass and peripheral points (degrees)

    Measured: Up to 2 years

  2. CTMA Total rotation

    Center of mass and peripheral points (degrees)

    Measured: Up to 5 years

  3. CTMA Total translation

    Center of mass and peripheral points (millimeters)

    Measured: Up to 2 years

  4. CTMA Total translation

    Center of mass and peripheral points (millimeters)

    Measured: Up to 5 years

  5. 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).

    Measured: Up to 2 years

  6. 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).

    Measured: Up to 5 years

  7. 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

    Measured: Up to 2 years

  8. 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

    Measured: Up to 5 years

  9. Range of motion

    From full extension to full flexion (degrees)

    Measured: Up to 2 years

  10. Range of motion

    From full extension to full flexion (degrees)

    Measured: Up to 5 years

  11. HKA

    Hip knee ankle angle measured on X-ray (degrees). Deviation from 0 is either varus (-) or valgus (+)

    Measured: Up to 2 years

  12. HKA

    Hip knee ankle angle measured on X-ray (degrees). Deviation from 0 is either varus (-) or valgus (+)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2022
  2. Study start6 Dec 2022
  3. Primary completion25 Jun 2028 (estimated)
  4. Study completion1 Jan 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05651009
Sponsor's protocol ID
520246
Acronym
ClessTKA
Status last verified
Aug 2026
First submitted
23 Nov 2022
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification

Publications

  • 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.

    PubMed 16826107

  • 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.

    PubMed 29232186

  • 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).

  • 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.

    PubMed 30368560

  • 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.

    PubMed 35809105

  • 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.

    PubMed 33821746

  • 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.

    PubMed 27478832

  • Bru F, Engseth LHW, Pripp AH, Schulz A, Aae TF, Husby VS, Husby OS, Rohrl SM, Ohrn FD. Dose reduction does not impact precision of CT-RSA in tibial components in total knee arthroplasty: a randomized controlled trial. J Orthop Surg Res. 2026 Mar 16;21(1):325. doi: 10.1186/s13018-026-06801-8.

    PubMed 41840645

Questions about this trial

What is this clinical trial studying?

A study testing TKA in people with Knee Osteoarthritis, run by Helse Møre og Romsdal HF at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CTMA Maximum Total Translation (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05651009, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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