Flex Intramedullary Rod Study

Arthroplasty, Replacement, Knee Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02543489
• Other study ID #: SJCR-OR-1103
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2012
• Est. completion date: September 2019

Study information

• Verified date: September 2018
• Source: Stryker Japan K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Flex IM rod

Locations

Country	Name	City	State
Japan	Hyogo College of Medicine Hospital	Nishinomiya	Hyogo
Japan	Osaka General Medical Center	Osaka
Japan	Saiseikai Yokohama East Hospital	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Japan K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum postoperative flexion angle		48 weeks after surgery
Secondary	Quality of life as assessed by36-Item Short-Form Health Survey (SF-36)questionnaire		4 weeks , 24 weeks and 48 weeks after surgery
Secondary	Japanese Knee Osteoarthritis Measure(JKOM)		4 weeks , 24 weeks and 48 weeks after surgery
Secondary	Knee Society Scale (KSS)		4 weeks , 24 weeks and 48 weeks after surgery
Secondary	Range of Motion (ROM)		4 weeks , 24 weeks and 48 weeks after surgery