Higher satisfaction after total knee arthroplasty using restricted inverse kinematic alignment compared to adjusted mechanical alignment.
Philip Winnock de Grave, Thomas Luyckx, Kurt Claeys...
https://pubmed.ncbi.nlm.nih.gov/32737528Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05516381
Evaluation of Navigation-Assisted Total Knee Arthroplasty Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures
Led by Exactech · Updated on 2024-06-18
148
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating clinical outcomes and patient-reported measures in patients undergoing total knee arthroplasty (TKA) using two surgical alignment techniques: restricted inverse kinematic alignment (iKA) and mechanical alignment (MA). The study focuses on comparing these two approaches, both performed with surgical navigation assistance, to understand their impact on patient recovery and knee function. The clinical trial is a prospective, randomized study involving up to 148 knee replacement surgeries. Participants will receive the Optetrak Logic CR total knee system. They will be randomly assigned to either the MA TKA group or the restricted iKA TKA group, with a 50% chance of being in each. All surgeries will use ExactechGPS navigation assistance to guide the procedure. Both participants and study staff involved in the evaluation will be blinded to the group assignments until study completion. During the study, participants will be monitored at 3, 6, and 12 months post-surgery using several scoring systems including the Knee Society Score (KSS), Forgotten Joint Score (FJS), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Visual Analog Scales (VAS) for pain and patient satisfaction. Researchers will also assess knee alignment during surgery. Participants will attend pre-operative and post-operative visits to support data collection and follow-up. The entire process will adhere to strict clinical research regulations and data privacy standards.
CONDITIONS
Brief Title
Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old at the time of surgery
- Participants will receive the Optetrak Logic CR knee device
- Participants must be willing to comply with all pre-operative and post-operative visit requirements
- Participants must be able to provide written informed consent for the study
You will not qualify if you...
- Presence of a suspected or confirmed systemic or remote infection
- Insufficient bone stock to allow proper insertion and fixation of the prosthesis
- Insufficient soft tissue integrity to provide adequate knee stability
- Mental or neuromuscular disorders preventing knee joint control
- Weight, age, or activity level that may cause extreme loads and early failure of the knee system
- Participation in another drug or device study (other than knee replacement) within the last 3 months
- Behavioral or mental issues interfering with ability to follow post-operative instructions
- Being a prisoner
- Pregnancy
- Undergoing radiation therapy targeting the knee joint
- Malignancy involving proximal tibia, distal femur, or knee joint
- Active chemotherapy treatment ongoing or planned during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery and immediate recovery period
Participants undergo navigation-assisted total knee arthroplasty using either mechanical or restricted kinematic alignment with the Optetrak Logic CR Knee System.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 12 months after surgery
Participants return for follow-up visits to assess knee function, pain, and satisfaction over time after surgery.
Follow-up visits at 3 months, 6 months, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C.
Barcelona, Spain
Actively Recruiting
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Research Team
A
Alex Knisely, BSBA
A
Amanda Ford, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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Published Research Related To This Trial
The Impact of Mechanical and Restricted Kinematic Alignment on Knee Anatomy in Total Knee Arthroplasty.
Abdulaziz M Almaawi, Jonathan R B Hutt, Vincent Masse...
https://pubmed.ncbi.nlm.nih.gov/28302462