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

The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement: a Randomized, Double-blind, Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: Cruciate-retaining (CR) prostheses; Device: Posterior-stabilized (PS) prostheses

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhao Yan, MD; Phone Number: +86-29-84775280; Email: yanzhaoii@163.com

Study Locations

• China
  • Xi'an, China
    • Recruiting
    • Xijing Hospital
    • Contact: Chongfei Yang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Patients with end-stage knee disease need Total Knee Arthroplasty in both knees.	Device: Cruciate-retaining (CR) prostheses; One leg is conducted TKA with Cruciate-retaining (CR) prostheses.; Device: Posterior-stabilized (PS) prostheses; One leg is conducted TKA with Posterior-stabilized (PS) prostheses.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Qingsheng Zhu, MD, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; PS; CR
• Other Study ID Numbers: XJ2018004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes