Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008, China
Not Yet Recruiting
NCT Number: NCT06617819
Influence of Different Prostheses on Postoperative Clinical Function in Total Knee Arthroplasty
Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS))
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
45 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age 45-80 years, any gender, BMI < 35 kg/m2
- Initial diagnosis of bilateral knee OA (Kellgren-Lawrence classification grades 3 or 4). Patients who are to undergo simultaneous primary bilateral knee arthroplasty
- Inversion deformity ≤ 15°
- Posterior cruciate ligament integrity
Exclusion criteria
- History of knee surgery (ligament, osteotomy, etc.)
- knee flexion<90°.
- flexion contracture of one knee > 10°
- Comorbidity with other diseases, such as peripheral neuropathy, malignant tumors, rheumatism, etc.
- Posterior cruciate ligament injury
- Those assessed to be intolerant of surgery
Treatment and study plan
CR prosthesis
DeviceFor patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.
PS prosthesis
DeviceFor patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.
Primary outcomes
-
Knee Society Score, KSS
Time frame: 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 outcomes
-
WOMAC
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Fei Yu, Doctor
CONTACT
Zhihong Xu, Doctor
CONTACT
Sponsors and collaborators
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Registry information
Official study title
Influence of Different Prostheses(CR Vs. PS) on Postoperative Clinical Functional Scores in Total Knee Arthroplasty Based on Extramedullary Femoral Osteotomy Techniques and Functionalist Alignment
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2027
- First posted
- Oct 1, 2024
- Registry last updated
- Oct 1, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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