The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty

The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty - The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000027849

Enrollment

100

Registered

2017-06-21

Start date

2017-06-10

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Osteoarthritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.The subject requires a primary total knee replacement 2.The subject is between 20 years old to 80 years old 3.The subject is diagnosed as osteoarthritis 4.The subject has intact collateral ligament 5.The subject has signed the IRB approved, study specific informed patient consent form 6.The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation

Exclusion criteria

Exclusion criteria: 1.The subject is pregnant 2.The subject has inflammatory arthritis 3.The subject is morbidly obese 4.The subject has had unicompartmental arthroplasty, high tibial osteotomy, femoral osteotomy and/or joint fusion 5.The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device 6.The subject has a systemic or metabolic disorder leading to progressive bone deterioration 7.The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements 8.The patient has a deformity which will require the use of stems, wedges or augments 9.The subject has an active or suspected latent infection in or about the knee joint 10.The patient who are inappropriate for participating in the study in the judgment of the investigator

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of medial component gap difference between extension and flexion for post-operative patient satisfaction and functional outcomes	—

Countries

Japan

Contacts

Public ContactSatoru Motohashi

Stryker Japan K.K. Clinical Affairs

NSKclinicaltrial@stryker.com03-6894-8394

Outcome results