The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement

Not Applicable

• Conditions: Total Knee Arthroplasty
• Interventions: Device: Cruciate-retaining (CR) prostheses; Device: Posterior-stabilized (PS) prostheses

• Registration Number: NCT03877042
• Lead Sponsor: Xijing Hospital

Brief Summary

The investigators will investigate the efficacy of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants.

Detailed Description

A randomized, single-center, single group study comparing the efficacy and safety of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants. Subjects will be monitored through postoperative follow-up to understand the bilateral knee condition.

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Study First Posted: 2019-03-15
• Last Update Posted: 2019-03-15
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adult patients who plan to undergo primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or rheumatoid arthritis, etc.;

Exclusion Criteria

• Those who do not meet the inclusion criteria;
• Neuromuscular dysfunction;
• Diseases affecting postoperative efficacy evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Cruciate-retaining (CR) prostheses	Patients with end-stage knee disease need Total Knee Arthroplasty in both knees.
Experimental	Posterior-stabilized (PS) prostheses	Patients with end-stage knee disease need Total Knee Arthroplasty in both knees.

Primary Outcome Measures

Name	Time	Method
KSS score changes after TKA	1,3,6,12 months after TKA	Summed Knee Society Score (KSS) score with a maximum score of 100. Higher values represent a better outcome.
X-ray evaluation changes after TKA	1,3,6,12 months after TKA	Evaluation of postoperative X-ray results for lower limb line, prosthesis location and other conditions
Muscle strength measurement changes after TKA	1,3,6,12 months after TKA	Strength measurement of related muscles according to Lovett muscle strength grading standard.
HSS score changes after TKA	1,3,6,12 months after TKA	Summed Hospital for special surgery (HSS) score with a maximum score of 100. Higher values represent a better outcome.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, China