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Clinical Trials/NCT06617819
NCT06617819
Not yet recruiting
Not Applicable

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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country40 target enrollmentSeptember 30, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Arthropathy
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment
40
Locations
1
Primary Endpoint
Knee Society Score, KSS
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 30, 2024
End Date
December 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible Party
Principal Investigator
Principal Investigator

Xu Zhihong

Professor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility Criteria

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

Outcomes

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\&#39;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(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 Sites (1)

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