Knee Arthropathy
Conditions
Brief summary
Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS))
Interventions
DEVICEPS prosthesis
For patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.
DEVICECR prosthesis
For patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 45-80 years, any gender, BMI \< 35 kg/m2 2. Initial diagnosis of bilateral knee OA (Kellgren-Lawrence classification grades 3 or 4). Patients who are to undergo simultaneous primary bilateral knee arthroplasty 3. Inversion deformity ≤ 15° 4. Posterior cruciate ligament integrity
Exclusion criteria
1. History of knee surgery (ligament, osteotomy, etc.) 2. knee flexion\<90°. 3. flexion contracture of one knee \> 10° 4. Comorbidity with other diseases, such as peripheral neuropathy, malignant tumors, rheumatism, etc. 5. Posterior cruciate ligament injury 6. Those assessed to be intolerant of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score, KSS | 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery | Use of Knee Society Score scales for assessment. Including pain, mobility, stability, the patient's ability to walk, up and down the stairs, etc. on the assessment, 85-100 is excellent, 70-84 is good, 60-69 is pass, less than 60 is poor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC | Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a composite outcome measure consisting of multiple measures: pain, stiffness and physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
| Stride length | Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery | The step length data were collected using a gait analysis instrument to analyze whether there was a difference between the right and left sides. |
| Stride frequency | Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery | The step frequency data were collected using an instrument to analyze whether there were any differences. |
| Percentage of stance phase | Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery | The stance phase is the time during which the lower limbs are in contact with the ground and are subjected to gravity, and accounts for 60% of the walking cycle. In walking disorders, the prolongation of the stance phase is often associated with impaired walking. |
Countries
China
Contacts
Primary ContactZhihong Xu, Doctor
Backup ContactFei Yu, Doctor
Outcome results
None listed