Clinical trial NCT00808613: Optetrak Posterior Stabilized Versus Optetrak Hi-Flex
Official title: Prospective, Single-center, Non-randomized, Consecutive Series Study Comparing Functional Differences Between a Standard Posterior Stabilized TKR and a High-flexion Posterior Stabilized TKR
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arthropathy of Knee
Arthritis and/or Post-traumatic Degenerative Problems
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2008-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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. The null hypothesis is that there is no difference in postoperative knee flexion between the Optetrak® PS and Optetrak® HF groups.

Eligibility criteria: Inclusion Criteria:

1. Patient is indicated for total knee replacement with a posterior stabilized device.
2. Patient is between the ages of 50 and 80 years old
3. Patient has a Body Mass Index (BMI) \< 35.0 using the following method (or comparable method)

   • BMI = Weight (lbs.) ÷ Height (in.)2 x 703
4. Patient is skeletally mature.
5. 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.
6. Patient is willing and able to review and sign a study Informed Consent.

Exclusion Criteria:

1. Patient has a Body Mass Index (BMI) \> 35.0 using the following method (or comparable method)

   • BMI = Weight (lbs.) ÷ Height (in.)2 x 703
2. Patient is skeletally mature
3. 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.
4. Patient is willing and able to review and sign a study Informed Consent.

Primary outcomes:
measure: The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.
timeFrame: 2 years
Secondary outcomes:
measure: Knee Society Score (KSS)
timeFrame: 2 years
measure: Hospital for Special Surgery (HSS) Knee Score
timeFrame: 2 years
measure: Patient Satisfaction
timeFrame: 2 years
measure: Implant survivorship
timeFrame: 2 years
measure: Radiographic evaluation
timeFrame: 2 years
measure: Complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Newport News
country: United States
facility: Hampton Roads Orthopedics
state: Virginia
Study officials:
affiliation: Exactech
name: Jason Drenning, Ph.D.
role: STUDY_DIRECTOR
affiliation: Hampton Roads Orthopedics
name: John W. Aldridge, MD
role: PRINCIPAL_INVESTIGATOR
References: