NCT02543489

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

6.8 years

First QC Date

August 10, 2015

Last Update Submit

September 13, 2018

Conditions

Osteoarthritis of the KneeArthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

  • Maximum postoperative flexion angle

    48 weeks after surgery

Secondary Outcomes (4)

  • 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

Study Arms (1)

Flex IM Rod

OTHER
Device: Flex IM rod

Interventions

Flex IM rodDEVICE
Flex IM Rod

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Revision cases
  • Patients that use bone wedges or allograft due to bone loss.
  • Patient has a Body Mass Index (BMI) \>40.
  • Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
  • Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
  • 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.
  • Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
  • Patient has failed unicondylar knee prosthesis.
  • Patient has a known sensitivity to device materials.
  • Patient who are inappropriate for participating in the study in the judgment of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hyogo College of Medicine Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Saiseikai Yokohama East Hospital

Yokohama, Kanagawa, 230-8765, Japan

Location

Osaka General Medical Center

Osaka, 558-8558, Japan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Yasuyuki Inatsugu

    Stryker Japan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

September 7, 2015

Study Start

December 1, 2012

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 14, 2018

Record last verified: 2018-09

Locations

JP(3)