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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03877042
• Other study ID #: XJ2018004
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

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