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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03877042
Enrollment
100
Registered
2019-03-15
Start date
2018-12-01
Completion date
2021-12-31
Last updated
2019-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty, CR, PS

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.

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.

Interventions

DEVICECruciate-retaining (CR) prostheses

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

DEVICEPosterior-stabilized (PS) prostheses

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

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HSS score changes after TKA1,3,6,12 months after TKASummed Hospital for special surgery (HSS) score with a maximum score of 100. Higher values represent a better outcome.
KSS score changes after TKA1,3,6,12 months after TKASummed Knee Society Score (KSS) score with a maximum score of 100. Higher values represent a better outcome.
X-ray evaluation changes after TKA1,3,6,12 months after TKAEvaluation of postoperative X-ray results for lower limb line, prosthesis location and other conditions
Muscle strength measurement changes after TKA1,3,6,12 months after TKAStrength measurement of related muscles according to Lovett muscle strength grading standard.

Countries

China

Contacts

Primary ContactZhao Yan, MD
yanzhaoii@163.com+86-29-84775280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026