Knee Osteoarthritis Clinical Trial
Official title:
Comparison of in Vivo Kinematics of Different Implants in ACL-sacrificing vs. Medially Stabilized Arthroplasty (Implant Design Study)
Verified date | February 2024 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patient satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implant designs have been developed to solve the problem. However, most of the designs are based on experimental data and not on in vivo kinematics. In this study, we will analyze the in vivo kinematics of the Global Medacta Knee Sphere (GMK Sphere) implant and compare it with a well documented design and implant (NexGen Cruciate Retaining (CR), Zimmer Biomet). We assume our study will contribute to the development of more satisfying knee implants.
Status | Active, not recruiting |
Enrollment | 26 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patients with knee osteoarthritis Exclusion Criteria: 1. Preoperative severe deformity (Femoro-tibial angle < 175°or > 190° measured on a full-length leg image at weight bearing) 2. Preoperative flexion contracture more than 15° 3. Preoperative limited range of motion under anesthetics (less than 110°) 4. Less than 50 or more than 75 years of age at the time of surgery 5. Use of walking aids because of other musculoskeletal and neuromuscular problems 6. Preoperative diagnosis other than osteoarthritis and avascular necrosis (e.g. rheumatoid arthritis, tumors) 7. Revision arthroplasty 8. Obesity with BMI>35 9. Impaired collateral ligaments 10. Postoperative KOOS score less than 80 11. Malposition of femoral and tibial implants (Internally rotated or more han 10° externally rotated implants will be excluded. The rotation of femoral implant is measured on postoperative CT images in reference to surgical epicondylar line. The rotation of tibial implant is determined according to Berger's measurement) 12. Limb surgery within 3 months before the analysis 13. Postoperative revision surgery due to deep wound infection |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital, Ullevål | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Helse More and Romsdal Trust |
Norway,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Kinematics measured though all Degrees of freedom (DOF) | Roentgen Fluoroscopic Stereophotogrammetric Analysis (RFSA). We measure all DOFs (i.e. X-Y-Z rotations and translations in degrees and millimeters respectively) | 1 year | |
Secondary | Knee Society Score (KSS) | Patient Reported Outcome Measure (PROM) | 1 year | |
Secondary | Knee injury and Osteoarthritis Outcome Score (KOOS) | PROM | 1 year | |
Secondary | Forgotten Joint Score 12 (FJS-12) | PROM | 1 year | |
Secondary | Range of motion (ROM) | Clinical measurement using goniometer | 1 year | |
Secondary | Hip-knee-ankle angle (HKA-angle) | The axis of the lower extremity after knee arthroplasty | 1 year | |
Secondary | CT-rotation of implants | Evaluation of tibia implant rotation using Berger's method | 1 year | |
Secondary | Clinical stability | Varus-valgus stability in clinical testing | 1 year |
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