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NCT Number: NCT04692714

Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented

Total knee replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant.

Implants can be cemented or cementless. The longevity of these implants depends among other things on the quality of the bone fixation of the implants. It is therefore essential that this fixation be evaluated. The advantages of an uncemented TKA are the preservation of bone stock, the absence of wear by cement debris and prolonged fixation thanks to osseointegration. These characteristics are all the more interesting in a young population.

Numerous studies have been carried out on the survival of TKA with and without cement. The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening. In addition, no study has evaluated the results of TKA with or without cement implanted using robotic assistance. The precision provided by the robotic system could improve the results of these uncemented implants.

Very few studies are interested in the functional results according to the cementation or not of TKA. And most of these studies do not have a high level of methodological evidence.

We would like to prospectively evaluate the functional results, survival, as well as the rate of radiological border after TKA with or without cement posed with robotic assistance, in the short and medium term.

Recruiting

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of internal, external or global femorotibial knee osteoarthritis
  • Indication for first-line total knee arthroplasty
  • having given informed consent
  • Affiliated with a social security scheme
  • Patient being able to understand the objectives of the study and willing to comply with postoperative instructions.

Exclusion criteria

  • Patient with rheumatoid arthritis
  • Preoperative flexion less than 90 °
  • Prosthesis associated with an osteotomy
  • History of surgery on the operated knee, except arthroscopy
  • Poor bone quality assessed by the surgeon
  • Knee deformation greater than 10 ° preoperatively (HKA)
  • Pregnant or breastfeeding Women
  • Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research
  • Adults subject to a legal protection measure
  • Patient already participating to another clinical trial that might jeopardize the current trial

Treatment and study plan

Knee prosthesis implementation with additional cement

Device

During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.

Knee prosthesis implementation without additional cement

Device

During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.

Primary outcomes

  1. Change from baseline in International Knee Society (IKS) function score at 12 Months

    Time frame: Baseline and 12 months

    The knee function will be evaluated using the delta of the IKS function score between baseline (before surgery) and 1 year after total knee arthroplasty, and compared between the 2 arms.

Secondary outcomes

  1. Change from baseline in IKS objective score at 12 Months

    Time frame: Baseline and 12 months

    The knee function will be evaluated using the delta of the IKS objective score between baseline (before surgery) and 1 year after total knee arthroplasty, and compared between the 2 arms.

  2. Change from baseline in IKS function score at 60 Months

    Time frame: Baseline and 60 months

    The knee function will be evaluated using the delta of the IKS function score between baseline (before surgery) and 5 years after total knee arthroplasty.

  3. Change from baseline in IKS objective score at 60 Months

    Time frame: Baseline and 60 months

    The knee function will be evaluated using the delta of the IKS objective score between baseline (before surgery) and 5 years after total knee arthroplasty.

  4. Forgotten joint score at 12 Months

    Time frame: 12 months

    Patient prosthesis acceptability will be evaluated thanks to the forgotten joint score 12 months after total knee arthroplasty

  5. Forgotten joint score at 60 Months

    Time frame: 60 months

    Patient prosthesis acceptability will be evaluated thanks to the forgotten joint score 60 months after total knee arthroplasty

  6. Presence of progressive radiological border at 12 Months

    Time frame: 12 months

    Progressive radiological border will be judged significant if it is at least 2 mm long at the interface between the implant (or cement) and the bone, or if it progresses in comparison to immediate post-surgical time.

  7. Unsealing free survival at 60 months

    Time frame: 60 months

    Unsealing free survival of knee prosthesis 60 months after total knee arthroplasty

Study contacts

Contact information is provided by the study sponsor or research team.

Julien BERTHILLER

CONTACT

[email protected]

33 (0) 4 72 11 80 67

Sébastien LUSTIG, Professor

CONTACT

[email protected]

33 (0) 4 26 10 92 98

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • Stryker Nordic

Registry information

Official study title

Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.

Acronym: MAKO CIMENT

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Jan 5, 2021
Registry last updated
Dec 3, 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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