Knee Pain Arthritis, Osteoarthritis (OA) of the Knee, Robotic Assisted Arthroplasty, Total Knee Arthroplasty (TKA)
Conditions
Keywords
Knee Osteoarthritis, Robotic-Assisted Total Knee Arthroplasty, Patient Reported Outcome Measures, Imageless Navigation, Image-based Navigation
Brief summary
The goal of this clinical trial is to learn if imageless navigation is not inferior to image-based navigation in robotic-assisted total knee arthroplasty (RA-TKA) for treating patients with knee osteoarthritis. The main questions the study aims to answer are: 1. Does imageless procedure provide functional results comparable to those of image-based navigation? 2. Are there differences in postoperative complications patients may experience after RA-TKA with imageless and image-based navigation? Researchers will compare imageless navigation with image-based navigation used in total knee arthroplasty to assess whether imageless navigation is comparable for the treatment of knee osteoarthritis. Participants will: 1. Answer survey questions about knee pain and function before RA-TKA. 2. Undergo RA-TKA with imageless navigation or image-based navigation. 3. Visit the Clinic after 6 months and 12 months after surgery for checkups and to answer the same survey questions about postoperative knee pain and function.
Detailed description
The trial will include patients with end-stage osteoarthritis, qualified for Robotic-Assisted Total Knee Arthroplasty (RA-TKA). For each patient, a full-length standing radiograph will be taken with designated sensors. Based on these, a three-dimensional model of the knee joint will be generated, enabling preoperative planning and intraoperative navigation in the image-based mode. Patients who meet the criteria and provide informed consent will be included in the study. Immediately before surgery, patients will be randomly assigned by a computer programme to either the experimental or control group in a 1:1 ratio, remaining blinded to the chosen method. In the experimental group, RA-TKA will be performed using imageless navigation, whereas in the control group, it will be performed using image-based navigation. In both groups, the procedure will be performed by experienced specialists with several years of experience, according to a standardized protocol: a medial parapatellar approach with restricted kinematic alignment, using a medial congruent knee implant. The total number of patients included in the study is planned to be 146, with 73 in the experimental group and 73 in the control group. The group size was calculated based on a power analysis; power level: 80%, significance level: α=0.05, minimal clinically important difference: 5 points on the Oxford Knee Score (OKS), standard deviation: 10 points on the OKS. The study's dropout rate is estimated at 15%. Radiologic imaging, survey responses, and intraoperative records will be stored on physical disks and paper, as well as in a secure cloud-based database. All other records will be stored digitally only. Registry data will be compared with external data sources (medical records) every 6 months to assess their accuracy and completeness. A Linear Mixed-Effects Model will be used to account for correlation between OKS measurements in the same patient. Both Per-Protocol and Intention-to-Treat analyses will be reported. For comparing continuous variables, a t-test (if normally distributed) or a Mann-Whitney U test (if skewed) will be used. Categorical variables will be compared with Fisher's Exact Test or the Chi-squared test. A cost-minimization analysis will be conducted using economic data.
Interventions
PROCEDUREImageless Robotic-Assisted Total Knee Arthroplasty
Patients undergoing Robotic-Assisted Total Knee Arthroplasty with Imageless Navigation
PROCEDUREImage-based Robotic-Assisted Total Knee Arthroplasty
Patients undergoing Robotic-Assisted Total Knee Arthroplasty with Image-based Navigation
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic, radiologically confirmed advanced osteoarthritis of the knee. 2. Patients referred for primary robotic-assisted total knee arthroplasty. 3. Patients in whom a correctly performed radiograph with designated sensors has confirmed the possibility of performing robotic-assisted total knee arthroplasty with image-based navigation. 4. Patients capable of giving informed consent to participate in the study and willing to attend all follow-up visits.
Exclusion criteria
1. No informed consent for the surgery. 2. No informed consent for taking part in the study. 3. Pregnancy. 4. Active infections. 5. Diagnosed comorbidities: autoimmune arthritis, malignant tumors, serious neurological disorders affecting a reliable functional outcome measurement (e.g., severe stroke, severe Parkinson's disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcome Measures assessed with the Oxford Knee Score | Survey taken right before surgery, at 6 months, and at 12 months after surgery. | Zero is equivalent to the worst possible function of the joint and 48 indicates the best achievable function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion | On admission to the hospital, at 6 months, and at 12 months postoperatively. | Measured according to the neutral-zero method with a 360-degree goniometer. |
| Number of Participants achieving a planned postoperative limb alignment | From enrollment to 12 months after surgery. | The percentage of patients within ±3 degrees of the preoperative target. |
| Postoperative radiographic results | From enrollment to 12 months after surgery. | Hip-Knee-Ankle angle, mechanical axis deviation, coronal femoral component angle (mechanical lateral distal femoral angle, mechanical lateral proximal femoral angle), sagittal femoral tilt/flexion, coronal tibial component angle (mechanical/anatomical lateral distal tibial angle, mechanical/anatomical medial proximal tibial angle) posterior tibial slope, joint line convergence angle, all measured in degrees |
| Postoperative pain assessed with a VAS scale | Survey taken right before surgery, at 6 months, and at 12 months after surgery. | Zero is equivalent to no pain and 10 indicates the worst possible pain. |
| Time of the surgical procedure | From the beginning to the end of the surgical procedure. | Duration of the surgical procedure in total and for each stage measured in minutes. |
| Estimation of perioperative blood loss | Immediately after the end of the surgery. | Intra-operative blood loss estimation by measuring the blood volume accumulated in suction bottles in milliliters, taking into account the volume of saline solution used during the surgery. |
| Difference between preoperative and postoperative hemoglobin levels | Hemoglobin levels will be measured within 2 weeks before surgery, as well as 24, 48 and 72 hours after surgery. | Hemoglobin levels will be obtained from samples taken at different times before and after surgery. |
| Postoperative complications | From enrollment to 12 months after surgery. | The percentage of cases with reported postoperative complications, such as: bleeding, wound complication, thromboembolic disease, neural deficit, vascular injury, ligament injury, instability, malalignment, stiffness, periprosthetic joint infection, periprosthetic fracture, extensor mechanism disruption, dislocation, bearing surface wear, osteolysis, implant loosening, revision, death. |
| Costs required for preoperative planning | From one month before enrollment to 12 months after surgery. | Costs of all preoperative imaging and procedures necessary to plan imageless and image-based robotic navigation. |
| Time required for preoperative planning | From one month before enrollment to 12 months after surgery. | Time required to prepare all preoperative imaging and procedures necessary to plan imageless and image-based robotic navigation. |
Countries
Poland
Contacts
CONTACTPaweł Kasprzak, MD
PRINCIPAL_INVESTIGATORPaweł Łęgosz, MD, Professor
Medical University of Warsaw
PRINCIPAL_INVESTIGATORŁukasz Pulik, MD, PhD
Medical University of Warsaw
PRINCIPAL_INVESTIGATORPaweł Kasprzak, MD
Medical University of Warsaw
Outcome results
None listed