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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03877042
Other study ID # XJ2018004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date December 2021

Study information

Verified date March 2019
Source Xijing Hospital
Contact Zhao Yan, MD
Phone +86-29-84775280
Email yanzhaoii@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Cruciate-retaining (CR) prostheses
One leg is conducted TKA with Cruciate-retaining (CR) prostheses.
Posterior-stabilized (PS) prostheses
One leg is conducted TKA with Posterior-stabilized (PS) prostheses.

Locations

Country Name City State
China Xijing Hospital Xi'an

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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