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

NCT ID: NCT03877042

Last Updated: 2019-03-15

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Patients with end-stage knee disease need Total Knee Arthroplasty in both knees.

Group Type EXPERIMENTAL

Cruciate-retaining (CR) prostheses

Intervention Type DEVICE

One leg is conducted TKA with Cruciate-retaining (CR) prostheses.

Posterior-stabilized (PS) prostheses

Intervention Type DEVICE

One leg is conducted TKA with Posterior-stabilized (PS) prostheses.

Interventions

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Cruciate-retaining (CR) prostheses

One leg is conducted TKA with Cruciate-retaining (CR) prostheses.

Intervention Type DEVICE

Posterior-stabilized (PS) prostheses

One leg is conducted TKA with Posterior-stabilized (PS) prostheses.

Intervention Type DEVICE

Eligibility Criteria

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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.;

* Neuromuscular dysfunction;
* Diseases affecting postoperative efficacy evaluation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yanzhao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qingsheng Zhu, MD

Role: STUDY_CHAIR

Air Force Military Medical University, China

Locations

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Xijing Hospital

Xi'an, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhao Yan, MD

Role: CONTACT

+86-29-84775280

Facility Contacts

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Chongfei Yang, M.D.

Role: primary

Other Identifiers

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XJ2018004

Identifier Type: -

Identifier Source: org_study_id

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