Flex Intramedullary Rod Study

Not Applicable

• Conditions: Osteoarthritis of the Knee; Arthroplasty, Replacement, Knee
• Interventions: Device: Flex IM rod

• Registration Number: NCT02543489
• Lead Sponsor: Stryker Japan K.K.

Brief Summary

The purpose of this study is to compare the effect of post-operative ROM between Flex IM rod and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the incidence of overhung with Flex IM rod.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
2. Patient is a male or non-pregnant female age 20 years or older.
3. Patient is candidate for primary Total Knee Arthroplasty (TKA).
4. Patient whose preoperative range of motion (ROM) is over 110 degree.
5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria

1. Revision cases
2. Patients that use bone wedges or allograft due to bone loss.
3. Patient has a Body Mass Index (BMI) >40.
4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
5. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
6. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
7. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
8. Patient has failed unicondylar knee prosthesis.
9. Patient has a known sensitivity to device materials.
10. Patient who are inappropriate for participating in the study in the judgment of the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flex IM Rod	Flex IM rod	-

Primary Outcome Measures

Name	Time	Method
Maximum postoperative flexion angle	48 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Quality of life as assessed by36-Item Short-Form Health Survey (SF-36)questionnaire	4 weeks , 24 weeks and 48 weeks after surgery
Japanese Knee Osteoarthritis Measure(JKOM)	4 weeks , 24 weeks and 48 weeks after surgery
Knee Society Scale (KSS)	4 weeks , 24 weeks and 48 weeks after surgery
Range of Motion (ROM)	4 weeks , 24 weeks and 48 weeks after surgery

Trial Locations

Locations (3)

Hyogo College of Medicine Hospital; 🇯🇵 Nishinomiya, Hyogo, Japan

Osaka General Medical Center; 🇯🇵 Osaka, Japan

Saiseikai Yokohama East Hospital; 🇯🇵 Yokohama, Kanagawa, Japan