NCT05936593

Brief Summary

Background: The choice whether or not to preserve the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) is coupled to the us of a PCL-retaining (CR) or a condylar (CS) insert. The CS insert is anterior-lipped (AL) to prevent anterior translation of the femur on the tibia with flexion and compensate the function of the PCL. Currently both the CR and CS insert are made of highly cross-linked polyethylene (HXPLE) to theoretically reduce wear related osteolysis. However, this also might diminish the fracture toughness and crack propagation of the insert. The investigators expect that due to the high contact forces on the anterior lip of the CS insert during flexion, especially in younger and more active patients, and the lower fracture toughness of HXPLE, the CS insert insert might show more migration, wear or other damage compared to the CR insert in the long-term, which might lead to more revisions in the CS insert compared to the CR insert. To measure the migration and wear, during surgery tantalum markers will be inserted in the host bone using a marker inserter. The displacement of the prosthesis with reference to the host bone will be measured using model-based RSA. Both tantalum markers ande the inserter are already used for study purposes. However, the safety and usability are not registered before. Objective: The primary objective is to compare the migration of both the femoral and tibial component by the use of a CS insert or CR insert both made of HXPLE using model-based roentgen stereophotogrammetric analysis (mRSA). Furthermore, the safety and usability of the tantalum markers and the marker inserter will be determined. The secondary objective is to determine the influence of the type of insert on the wear, inducible displacement, survival and clinical outcomes. Study design: A randomized controlled trial Study population: Forty-four patients scheduled to undergo primary total knee replacement, aged below 70 years with an ASA-score of 1 or 2 will be needed in total, divided in two groups of 22 patients each. Intervention: One group receives an uncemented TKP with a CS insert, while the other group receives an uncemented TKP with a CR insert. Both will be placed using the MAKO-robotic arm using a kinematic balancing technique. Outcomes: Main study parameters are migration of the femoral and tibial components measured with model-based RSA software till 10 years postoperatively. Furthermore, the stability of the markers will be determined and the complications due to the markers and/or the marker inserter will be registered. The secondary parameters are wear, inducible displacement, survival, clinical outcomes and complications up to 10 years postoperatively.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
110mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Jul 2023Jun 2035

First Submitted

Initial submission to the registry

June 12, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

July 21, 2023

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2035

Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

11.9 years

First QC Date

June 12, 2023

Last Update Submit

December 12, 2023

Conditions

Wear of Articular Bearing Surface of Prosthetic JointMigration of Implant

Keywords

Total knee arthroplastyInsert

Outcome Measures

Primary Outcomes (4)

  • Translations (mm)

    The translations of the femoral and tibial components measured in 3 axis (z, y and z) with model-based RSA over 10 years.

    10 years after surgery

  • Rotations (degrees)

    The rotations of the femoral and tibial components measured in 3 axis (z, y and z) with model-based RSA over 10 years.

    10 years after surgery

  • Stability of the tantalum markers

    Stability of the tantalum markers will be determined by the mean error value of the markers.

    10 years after surgery

  • Safety of the tantalum markers and the inserter

    Safety of the tantalum markers are determined by registration of the complications due to the markers and/or marker inserter. Complications will be expressed by numbers and percentages.

    10 years after surgery

Secondary Outcomes (11)

  • Wear

    10 years after surgery

  • Inducible displacement (mm)

    10 years after surgery

  • Inducible displacement (degrees)

    10 years after surgery

  • Survival

    10 years after surgery

  • Clinical outcomes: Knee Society Score (KSS)

    10 years after surgery

  • +6 more secondary outcomes

Study Arms (2)

Condylar Stabilizing (CS) insert

ACTIVE COMPARATOR
Device: Condylar Stabilizing (CS) insert

Cruciate Retaining (CR) insert

ACTIVE COMPARATOR
Device: Cruciate Retaining (CR) insert

Interventions

Condylar Stabilizing (CS) insertDEVICE

During TKA surgery a Condylar Stabilizing (CS) insert is implanted and tantalum beads are placed around the prosthesis.

Condylar Stabilizing (CS) insert
Cruciate Retaining (CR) insertDEVICE

During TKA surgery a Cruciate Retaining (CR) insert is implanted and tantalum beads are placed around the prosthesis.

Cruciate Retaining (CR) insert

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo primary total knee replacement with the MAKO-robotic arm, with one of the following indications:
  • Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis.
  • One or more compartments are involved;
  • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability (meaning a varus, valgus or flexion deformity \< 15 degrees);
  • Age between 18 and 70 years;
  • ASA score I or II;
  • A good nutritional state of the patient;
  • Patients with a completely intact PCL at the time of surgery;
  • Patient is able to understand the study and is willing to participate and to sign the Informed Consent;
  • Patient is able to speak and write Dutch.

You may not qualify if:

  • Contraindications manufacturer:
  • Any active or suspected latent infection in or about the knee joint;
  • Distant foci of infection which may cause hematogenous spread to the implant site;
  • Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care;
  • Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis;
  • Skeletal immaturity;
  • Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function;
  • Metal in the operative or non-operative leg which lead to the creation of accuracy-reducing artefacts in the CT scan;
  • Body Mass Index (BMI) of \> 35 kg/m2;
  • Flexion contracture of 15 degrees and more;
  • Varus/valgus contracture of 15 degrees and more;
  • History of total or unicompartmental reconstruction of the affected joint;
  • Bilateral operation;
  • A Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA \> 1 year ago with good outcome can be included in the study);
  • A Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA \> 6 months ago with good outcome can be included in the study);
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, 2725 NA, Netherlands

RECRUITING

MeSH Terms

Interventions

Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Central Study Contacts

J. Pasma

CONTACT

079 - 206 5595Onderzoek@rhoc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

July 10, 2023

Study Start

July 21, 2023

Primary Completion (Estimated)

June 1, 2035

Study Completion (Estimated)

June 1, 2035

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations

NL(1)