Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

NCT00808613 | Withdrawn

• 1 other identifier: CR07-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized ("Optetrak® PS", Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ ("Optetrak® HF", Exactech, Gainesville, FL) knee designs.

Conditions

Arthropathy of Knee; Arthritis and/or Post-traumatic Degenerative Problems

Outcome Measures

Primary Outcomes (1)

• The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.

  Physician assess range of motion in knee joint

  2 years

Secondary Outcomes (6)

• Knee Society Score (KSS)

  2 years

• Hospital for Special Surgery (HSS) Knee Score

  2 years

• Patient Satisfaction

  2 years

• Implant survivorship

  2 years

• Radiographic evaluation

  2 years

Study Arms (2)

Optetrak Posterior Stabilized TKR

ACTIVE COMPARATOR

Subjects in this arm will receive an Optetrak Posterior Stabilized total knee system.

Device: Optetrak PS

Optetrak Hi-Flex TKR

ACTIVE COMPARATOR

Subjects in this arm will receive an Optetrak Hi-Flex total knee system.

Device: Optetrak Hi-Flex

Interventions

Optetrak PS DEVICE

Optetrak Posterior Stabilized total knee replacement

Optetrak Posterior Stabilized TKR

Optetrak Hi-Flex DEVICE

Optetrak Hi-Flex total knee replacement

Optetrak Hi-Flex TKR

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is indicated for total knee replacement with a posterior stabilized device.
• Patient is between the ages of 50 and 80 years old
• Patient has a Body Mass Index (BMI) \< 35.0 using the following method (or comparable method)
• BMI = Weight (lbs.) ÷ Height (in.)2 x 703
• Patient is skeletally mature.
• Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of studyrequired questionnaires.
• Patient is willing and able to review and sign a study Informed Consent.

You may not qualify if:

• Patient has a Body Mass Index (BMI) \> 35.0 using the following method (or comparable method)
• BMI = Weight (lbs.) ÷ Height (in.)2 x 703
• Patient is skeletally mature
• Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of study required questionnaires.
• Patient is willing and able to review and sign a study Informed Consent.

Sponsors & Collaborators

• Exactech: lead

Study Sites (1)

Hampton Roads Orthopedics

Newport News, Virginia, 23606, United States

Location

Study Officials

• Jason Drenning, Ph.D.

  Exactech

  STUDY DIRECTOR

• John W. Aldridge, MD

  Hampton Roads Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 16, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

US (1)