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Not yet recruiting NCT06617819

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

No phase Interventional Knee Arthropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CR prosthesis, PS prosthesis.
Who it may be relevant to
Registry conditions: Knee Arthropathy. Basic parameters: 45 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

Interventions

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

Primary outcome measures

  • Knee Society Score, KSS [Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery]
Secondary outcome measures (4)
  • WOMAC [Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery]
  • Stride length [Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery]
  • Stride frequency [Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery]
  • Percentage of stance phase [Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University — Nanjing

Identifiers

NCT: NCT06617819 · 2024-6668-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗