Influence of Different Prostheses on Postoperative Clinical Function in Total Knee Arthroplasty

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

Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS))

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Arthropathy
• Intervention / Treatment: Device: CR prosthesis; Device: PS prosthesis

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhihong Xu, Doctor; Phone Number: 13912988032; Email: xuzhihongjoint@hotmail.com
• Study Contact Backup: Name: Fei Yu, Doctor; Phone Number: 15151842733; Email: dr.feiyu@foxmail.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
      • Contact: Zhihong Xu, Doctor; Phone Number: 13912988032; Email: xuzhihongjoint@hotmail.com
      • Contact: Zhihong Xu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; CR prosthesis for the left knee	Device: CR prosthesis; For patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.
Active Comparator: control group; PS prosthesis for the left knee	Device: PS prosthesis; For patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score, KSS	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	6 weeks, 3 months, 6 months, 12 months, 24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC	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.	Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Stride length	The step length data were collected using a gait analysis instrument to analyze whether there was a difference between the right and left sides.	Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Stride frequency	The step frequency data were collected using an instrument to analyze whether there were any differences.	Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Percentage of stance phase	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.	Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Investigators: Principal Investigator: Zhihong Xu, Doctor, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 22, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2024-6668-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be available by consulting the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes