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NCT Number: NCT05651009

Comparison of the in Vivo Stability of 2 Cementless TKA Designs

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kristiansund Hospital, Møre and Romsdal Hospital Trust

Kristiansund, Møre and Romsdal, 6508, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TKA

Procedure

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

Primary outcomes

  1. CTMA Maximum Total Translation

    Time frame: Up to 2 years

    The highest total translation on the implant at each time point

  2. CTMA Maximum Total Translation

    Time frame: Up to 5 years

    The highest total translation on the implant at each time point

Secondary outcomes

  1. CTMA Total rotation

    Time frame: Up to 2 years

    Center of mass and peripheral points (degrees)

  2. CTMA Total rotation

    Time frame: Up to 5 years

    Center of mass and peripheral points (degrees)

  3. CTMA Total translation

    Time frame: Up to 2 years

    Center of mass and peripheral points (millimeters)

  4. CTMA Total translation

    Time frame: Up to 5 years

    Center of mass and peripheral points (millimeters)

  5. The Forgotten Joint Score (FJS)

    Time frame: Up to 2 years

    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).

  6. The Forgotten Joint Score (FJS)

    Time frame: Up to 5 years

    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).

  7. The Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Up to 2 years

    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

  8. The Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Up to 5 years

    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

  9. Range of motion

    Time frame: Up to 2 years

    From full extension to full flexion (degrees)

  10. Range of motion

    Time frame: Up to 5 years

    From full extension to full flexion (degrees)

  11. HKA

    Time frame: Up to 2 years

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

  12. HKA

    Time frame: Up to 5 years

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

Other outcomes

  1. BMI

    Time frame: Preoperative

    Body mass index (kg/m2)

  2. Operation time

    Time frame: Intraoperative

    Time used in minutes from skin incision to wound closure.

  3. Axial alignment of the tibia

    Time frame: Up to 1 week postoperative

    Measured by Bergers method (degrees internal or extarnal rotation)

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Collaborators

  • Medacta International SA
  • Oslo University Hospital

Registry information

Official study title

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

Acronym: ClessTKA

Important dates

Study start
2022
Primary completion
2028
Study completion
2033
First posted
Dec 14, 2022
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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