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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2027-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Knee Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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experimental group

CR prosthesis for the left knee

Group Type EXPERIMENTAL

CR prosthesis

Intervention Type DEVICE

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

control group

PS prosthesis for the left knee

Group Type ACTIVE_COMPARATOR

PS prosthesis

Intervention Type DEVICE

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

Interventions

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CR prosthesis

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

Intervention Type DEVICE

PS prosthesis

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No