Arthropathy of KneeNCT00808613
Optetrak Posterior Stabilized Versus Optetrak Hi-Flex
A study testing Optetrak PS and Optetrak Hi-Flex in people with Arthropathy of Knee and Arthritis and/or Post-traumatic Degenerative Problems, run by Exactech at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Arthropathy of Knee, Arthritis and/or Post-traumatic Degenerative Problems
- What is being tested?
- Optetrak PS and Optetrak Hi-Flex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hampton Roads Orthopedics
Newport News, Virginia, 23606
About this study
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
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.
Read the 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.
- Being tested
- Optetrak PS, Optetrak Hi-Flex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optetrak PSDevice
Optetrak Posterior Stabilized total knee replacement
Optetrak Hi-FlexDevice
Optetrak Hi-Flex total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| Optetrak Posterior Stabilized TKR | Active comparator | Subjects in this arm will receive an Optetrak Posterior Stabilized total knee system. Receives: Device: Optetrak PS |
| Optetrak Hi-Flex TKR | Active comparator | Subjects in this arm will receive an Optetrak Hi-Flex total knee system. Receives: Device: Optetrak Hi-Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.
Physician assess range of motion in knee joint
Measured: 2 years
Secondary outcomes (6)
Knee Society Score (KSS)
Validated physician assessed outcome
Measured: 2 years
Hospital for Special Surgery (HSS) Knee Score
Validated physician assessed outcome
Measured: 2 years
Patient Satisfaction
Visual Analog Scale (1-10) where 10 is best.
Measured: 2 years
Implant survivorship
Implant survivorship
Measured: 2 years
Radiographic evaluation
Radiographic analysis
Measured: 2 years
Complications
Adverse Events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startDec 2008 (estimated)
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Study withdrawn prior to initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Drenning, Ph.D., Study director, ExactechJohn W. Aldridge, MD, Principal investigator, Hampton Roads Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808613
- Sponsor's protocol ID
- CR07-001
- Status last verified
- Aug 2022
- First submitted
- 15 Dec 2008
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00808613
- Acronym / sponsor ID
- CR07-001
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn prior to initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- Dec 2008 (estimated)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optetrak Posterior Stabilized TKR | Active comparator | Device: Optetrak PSSubjects in this arm will receive an Optetrak Posterior Stabilized total knee system. |
| Optetrak Hi-Flex TKR | Active comparator | Device: Optetrak Hi-FlexSubjects in this arm will receive an Optetrak Hi-Flex total knee system. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- 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.
Key exclusion criteria (5 listed)
- Patient has a Body Mass Index (BMI) > 35.0 using the following method (or comparable method)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optetrak PSOptetrak Posterior Stabilized total knee replacement | Device | Optetrak Posterior Stabilized TKR |
| Optetrak Hi-FlexOptetrak Hi-Flex total knee replacement | Device | Optetrak Hi-Flex TKR |
Primary outcome
The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.
Time frame: 2 years
Physician assess range of motion in knee joint
6 secondary outcomes
Knee Society Score (KSS)
Time frame: 2 years
Hospital for Special Surgery (HSS) Knee Score
Time frame: 2 years
Patient Satisfaction
Time frame: 2 years
Implant survivorship
Time frame: 2 years
Radiographic evaluation
Time frame: 2 years
Complications
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Drenning, Ph.D. study director
Exactech
John W. Aldridge, MD principal investigator
Hampton Roads Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optetrak PS and Optetrak Hi-Flex in people with Arthropathy of Knee and Arthritis and/or Post-traumatic Degenerative Problems, run by Exactech at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.