Health TrialsbyHealthPanel

Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment

ConditionKnee Arthroplasty, Total
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorExactech

About this trial

The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subject must be at least 18 years of age at the time of the surgery (skeletally mature)

Subject will receive a Optetrak Logic® CR device per the "Indications for Use" described above

Subject must be willing to comply with the pre-operative and post-operative visit requirements

Subject must be willing and able to provide written informed consent for participation in the study

Disqualifiers

Subject with a suspected or confirmed systemic infection and/or a secondary remote infection

Subject without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis

Subject without sufficient soft tissue integrity to provide adequate stability

Subject with either mental or neuromuscular disorders that do not allow control of the knee joint

Trial design

Design model

Single group

Treatments tested in this trial

  • Optetrak Logic CR Knee System

    Device

    The OPTETRAK® Comprehensive Knee System consists of the OPTETRAK® Total Knee System and the OPTETRAK Logic® Total Knee System. The OPTETRAK Comprehensive Knee System comprises both non-porous and porous knee prostheses for use in total-knee joint replacement procedures. (In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.) The system includes various sizes and types of modular femoral components, tibial components, patellar components, and accessories for use in primary and revision applications.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Restricted Invers Kinematic Knee Alignment TechniqueOther 1 intervention
Group B: Mechanical Knee Alignment TechniqueOther 1 intervention

Trial outcomes

Primary outcomes

1

Knee Society Score (KSS)

Validated outcome score

Time frame
3-month
2

Knee Society Score (KSS)

Validated outcome score

Time frame
6-month
3

Knee Society Score (KSS)

Validated outcome score

Time frame
12-month
4

Forgotten Joint Score (FJS)

Validated outcome score

Time frame
3-month

Secondary outcomes

1

Knee Alignment

Characterization of knee in terms of ligament balancing will be assessed through constant-pressure full arc of motion measurement.

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Exactech

Lead sponsor

Source ClinicalTrials.gov
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