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

Not Applicable

Not yet recruiting

• Conditions: Knee Arthropathy
• Interventions: Device: PS prosthesis; Device: CR prosthesis

• Registration Number: NCT06617819
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-22
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study Start: 2024-09-30
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	PS prosthesis	PS prosthesis for the left knee
experimental group	CR prosthesis	CR prosthesis for the left knee

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University; 🇨🇳 Nanjing, Jiangsu, China