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

NCT06617819 | Not Yet Recruiting FDA Device

• 1 other identifier: 2024-6668-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Arthropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• WOMAC

  Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery

• Stride length

  Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery

• Stride frequency

  Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery

• Percentage of stance phase

  Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery

Study Arms (2)

experimental group

EXPERIMENTAL

CR prosthesis for the left knee

Device: CR prosthesis

control group

ACTIVE COMPARATOR

PS prosthesis for the left knee

Device: PS prosthesis

Interventions

CR prosthesis DEVICE

For patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.

experimental group

PS prosthesis DEVICE

For patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.

control group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, 210008, China

Location

Study Officials

• Zhihong Xu, Doctor

  Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihong Xu, Doctor

CONTACT

13912988032; xuzhihongjoint@hotmail.com

Fei Yu, Doctor

CONTACT

15151842733; dr.feiyu@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: October 1, 2024
• Study Start: September 30, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)