NCT03877042

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

March 6, 2019

Last Update Submit

March 13, 2019

Conditions

Total Knee Arthroplasty

Keywords

Total Knee ArthroplastyCRPS

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Experimental

EXPERIMENTAL

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

Device: Cruciate-retaining (CR) prosthesesDevice: Posterior-stabilized (PS) prostheses

Interventions

Cruciate-retaining (CR) prosthesesDEVICE

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

Experimental
Posterior-stabilized (PS) prosthesesDEVICE

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

Experimental

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Neuromuscular dysfunction;
  • Diseases affecting postoperative efficacy evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, China

RECRUITING

MeSH Terms

Interventions

Prostheses and Implants

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Qingsheng Zhu, MD

    Air Force Military Medical University, China

    STUDY CHAIR

Central Study Contacts

Zhao Yan, MD

CONTACT

+86-29-84775280yanzhaoii@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 15, 2019

Study Start

December 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

CN(1)