OsteoarthritisNCT02962362
Study to Assess Exactech's Guided Personalized Surgery eGPS® in Total Knee Arthroplasty
An observational study of Osteoarthritis, run by Exactech at 1 site in United States.
Trial summary
Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Nov 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred (100) subjects enrolled up to 4 sites. All subjects will be screened, enrolled and evaluated prospectively and be followed for up to two years. In the event a subject is enrolled and does not have surgery, additional patients may be screened and enrolled to reach the 100 subjects.
Who may be able to join
- Patient requires a primary Optetrak Logic Total Knee Arthroplasty
- Patient is skeletally mature with no obvious mechanical defect
- Patient is mentally capable of completing follow-up visits
- Patient is 18 years of age or greater at time of surgery
- Patient will be available for follow-up out to 2 years
- Patient has consented to participate in the clinical study
Who cannot join
- Patient has a mental or physical condition that may invalidate evaluation of the data
- Patient is a prisoner
- Surgery is contraindicated according to the applicable product package insert
- Patient has a local or systemic infection
- Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
- Patient is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multi-center Data Collection to Assess the Exactech Guided Personalized Surgery eGPS® in Total Knee Arthroplasty
Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA).
Read the detailed description
The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.
- Conditions
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital for Special Surgery knee score (HSS)
total score, pain, function
Measured: 24 Months
Oxford Knee Score (OKS)
function, pain
Measured: 24 Months
Knee Society Score (KSS)
total score, pain, function
Measured: 24 Months
Knee injury and Osteoarthritis Outcome Score (KOOS)
total score and subscales
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2019
- Study completionNov 2021
Why it stopped: Unable to complete enrollment of subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962362
- Sponsor's protocol ID
- CR15-001
- Status last verified
- Aug 2022
- First submitted
- 8 Nov 2016
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
- A Prospective Multi-center Data Collection to Assess the Exactech Guided Personalized Surgery eGPS® in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02962362
- Acronym / sponsor ID
- CR15-001
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to complete enrollment of subjects.
- Enrolment
- 73 participants (actual)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Jul 2019 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 11 Nov 2016 (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.
Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA).
Detailed description
The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred (100) subjects enrolled up to 4 sites. All subjects will be screened, enrolled and evaluated prospectively and be followed for up to two years. In the event a subject is enrolled and does not have surgery, additional patients may be screened and enrolled to reach the 100 subjects.
Key inclusion criteria (6 listed)
- Patient requires a primary Optetrak Logic Total Knee Arthroplasty
- Patient is skeletally mature with no obvious mechanical defect
- Patient is mentally capable of completing follow-up visits
- Patient is 18 years of age or greater at time of surgery
- Patient will be available for follow-up out to 2 years
Key exclusion criteria (6 listed)
- Patient has a mental or physical condition that may invalidate evaluation of the data
- Patient is a prisoner
- Surgery is contraindicated according to the applicable product package insert
- Patient has a local or systemic infection
- Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital for Special Surgery knee score (HSS)
Time frame: 24 Months
total score, pain, function
Oxford Knee Score (OKS)
Time frame: 24 Months
function, pain
Knee Society Score (KSS)
Time frame: 24 Months
total score, pain, function
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 24 Months
total score and subscales
Results and safety
The study was stopped early (reason given: Unable to complete enrollment of subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, 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 6 inclusion and 6 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: stopped early, 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 stopped early (reason given: Unable to complete enrollment of subjects.). Results are not available in the source record.
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?
Hospital for Special Surgery knee score (HSS) (time frame: 24 Months). The study lists 4 primary outcomes in all. 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.