Flex Intramedullary Rod Study

September 13, 2018 updated by: Stryker Japan K.K.

A Prospective, Post-market, Multi-center Comparative Study of the Efficacy of Flex Intramedullary(IM) Rod in Terms of Range of Motion (ROM) Improvement.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 558-8558
        • Osaka General Medical Center
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Hyogo College of Medicine Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 230-8765
        • Saiseikai Yokohama East Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Flex IM Rod
Device: Flex IM rod

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum postoperative flexion angle
Time Frame: 48 weeks after surgery
48 weeks after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Japan K.K.

Investigators

  • Study Director: Yasuyuki Inatsugu, Stryker Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJCR-OR-1103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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