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OpenTrials
Completed

NCT Number: NCT02966613

Fully Disposable Patient-Specific Instrumentation

To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.

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Key information

Conditions

Osteoarthritis,Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The investigators performed a controlled multicenter trial comparing the clinical and radiologic results and resources consumption of primary TKA using patient-specific cutting guides (PSCG) versus conventional instrumentation (CI), and compared the results to those obtained with a fully disposable patient-specific instrumentation (PSCG-D).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged between 18 and 85 years
  • able to understand information
  • affiliated to social security

Exclusion criteria

  • active or suspected sepsis
  • tumor around the knee
  • previous partial or total knee replacement
  • extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
  • social situation that could impair follow-up

Treatment and study plan

GMK Medacta Total Knee arthroplasty

Device

Total Knee arthroplasty

Primary outcomes

  1. HKA angle

    Time frame: 3 months

    Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the Hip-Knee-Ankle (HKA) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.

Secondary outcomes

  1. % outliers

    Time frame: 3 months

    % of patients with an HKA angle outside 180°+/- 3°

  2. Knee Society Score

    Time frame: 3 months

    Validated pain and function score following TKA

  3. Oxford Knee Score

    Time frame: 3 months

    Patients self assessment of knee function

Sponsors and collaborators

Lead sponsor

Cochin Hospital

Ambig

Registry information

Official study title

Primary TKA Using a Fully Disposable Patient-Specific Instrumentation: A Multicenter Controlled Study

Acronym: MyKnee

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Nov 17, 2016
Registry last updated
Nov 17, 2016

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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