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OpenTrials
Completed

NCT Number: NCT02706990

Fluoroscopic Analysis of Total Knee Replacement With a Kinematic Retaining or a Posterior Stabilized Design

The aim of this study is to evaluate the in vivo kinematics of TKA performed with two different prosthesis: a kinematic retaining (Physica KR) and a posterior-stabilized (Physica PS) design by means of fluoroscopic analysis during activities of daily living (rising from a chair, stairs climbing, leg extension). In comparison with asymptomatic knee. Patterns of femoral rollback will be analyzed to assess if they are motor-task dependent and correlated with clinical outcomes.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale San Camillo

Trento, 38122, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients submitted to Total knee arthroplasty (TKA) with Physica KR or PS;
  • Patients with an appropriate initial fixation and stability of the knee prosthesis;
  • Patients achieving a minimum flexion of 100° or a Knee Society Score (KSS) ≥ 65 (fair/good postoperative outcome) at 6-month follow-up;
  • Patients affected by primary or secondary Osteoarthritis (OA) before surgery;
  • Patients who understand the requirements of the study and are willing and able to comply with activities required for fluoroscopic examination;
  • Patients who have signed the Ethics Committee approved study-specific Informed Consent Form.

Exclusion criteria

  • Patients with misalignment or axial malrotation of the knee prosthesis;
  • Patients not able to achieve a minimum flexion of 100° or with a KSS Knee Score ≤ 65 points at 6-month follow-up;
  • Patients who had or have planned a surgery on their uninvolved knee within a year;
  • Muscular insufficiency or absence of muscololigamentous supporting structures required for adequate soft tissue balance;
  • Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation;
  • Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device;
  • Any psychiatric illness that would prevent comprehension of the details and nature of the study;
  • Participation in any experimental drug/device study within the 6 months prior to the screening visit
  • Female patients who are pregnant, nursing, or planning a pregnancy due to x-rays exposition.

Treatment and study plan

Physica KR

Device

Kinematic retaining total knee implant

Physica PS

Device

Posterior stabilized total knee implant

Primary outcomes

  1. Assessment of the roll-back mechanism measured with the tibio-femoral contact points at different degrees of flexion

    Time frame: 6 months

    Using a software to replicate the movement using Computer-aided design (CAD) models. The movement is studied and the distance made by the femur on the tibia is calculated giving the information of the roll back.

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Registry information

Official study title

In Vivo Kinematic Analysis of Total Knee Replacement With a Kinematic Retaining or a Posterior Stabilized Design During Activities of Daily Living

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2016
Registry last updated
Mar 7, 2017

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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