A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
ConditionKnee Arthroplasty, Total
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorExactech
About this trial
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® Knee System
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
Skeletally mature (18 years of age or older).
Subject is willing and able to provide written informed consent for participation in the study.
Subject is to receive a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee.
Disqualifiers
Gender
Age at surgery
Height/Weight
Indication for surgery
Trial population
The Truliant® Femoral Components, Tibial Inserts, Patellar Component and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Truliant® Cemented Femoral Components, Tibial Inserts, Patellar Component and Tibial Trays are indicated for cemented use only. The Truliant® Porous Femoral Components are indicated for cemented or cementless use. The Truliant® Porous Tibial Trays are indicated for cemented or cementless use. Patients must qualify for surgery per indications and contraindications as well as meet all of the inclusion criteria and none of the exclusion criteria. The decision to offer a patient enrollment in this study is left to the discretion of the surgeon.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Truliant Total Knee System
DeviceTotal Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components.
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: Prospective Subjects1 intervention
Group B: Retrospective to Prospective1 intervention
Group C: Retrospective Only Subjects1 intervention
Trial outcomes
Primary outcomes
1
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Time frame
Preoperative2
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Time frame
1 year3
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Time frame
2 year4
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Time frame
3 year Source ClinicalTrials.gov