Clinical trial NCT02543489: Flex Intramedullary Rod Study
Official title: A Prospective, Post-market, Multi-center Comparative Study of the Efficacy of Flex Intramedullary(IM) Rod in Terms of Range of Motion (ROM) Improvement.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis of the Knee
Arthroplasty, Replacement, Knee
Lead sponsor: Stryker Japan K.K.
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum postoperative flexion angle
timeFrame: 48 weeks after surgery
Secondary outcomes:
measure: Quality of life as assessed by36-Item Short-Form Health Survey (SF-36)questionnaire
timeFrame: 4 weeks , 24 weeks and 48 weeks after surgery
measure: Japanese Knee Osteoarthritis Measure(JKOM)
timeFrame: 4 weeks , 24 weeks and 48 weeks after surgery
measure: Knee Society Scale (KSS)
timeFrame: 4 weeks , 24 weeks and 48 weeks after surgery
measure: Range of Motion (ROM)
timeFrame: 4 weeks , 24 weeks and 48 weeks after surgery
Other outcomes:
Locations:
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital
state: Hyogo
city: Yokohama
country: Japan
facility: Saiseikai Yokohama East Hospital
state: Kanagawa
city: Osaka
country: Japan
facility: Osaka General Medical Center
Study officials:
affiliation: Stryker Japan
name: Yasuyuki Inatsugu
role: STUDY_DIRECTOR
References: