Knee Arthroplasty, TotalNCT05788757
Optetrak Knee System Post Market Clinical Follow-Up
An observational study of Knee Arthroplasty, Total, run by Exactech at 3 sites in United States.
Trial summary
A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Optetrak Total Knee System
- Type of treatment
- Medical device
- How many people
- 4,588 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2011to 1 Jun 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients must qualify for surgery per indications and contraindications as well as meet all the inclusion criteria and none of the exclusion criteria. The decision to offer a patient enrollment in this study is left to the discretion of the surgeon.
Who may be able to join
- Patient is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech
- Patient is skeletally mature
- Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary
Who cannot join
- 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
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University South Carolina
Charleston, South Carolina, 29425
Nevada Orthopaedic and Spine Center
Las Vegas, Nevada, 89128
Fallon Clinic
Worcester, Massachusetts, 01608
About this study
Official title: A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
Read the detailed description
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Optetrak® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Optetrak Total Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optetrak Total Knee SystemDevice
Total Knee Arthroplasty using Exactech's Optetrak branded components.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Subjects | Patients recruited from the population undergoing knee arthroplasty as part of standard of care. Patients who meet all the inclusion criteria and none of the exclusion criteria should be presented with an opportunity to undergo the informed consent process. Receives: Device: Optetrak Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
(KSS) - validated outcome score
Measured: Preoperative
Knee Society Score
(KSS) - validated outcome score
Measured: 6 month postoperative
Knee Society Score
(KSS) - validated outcome score
Measured: annually through study completion, maximum of 10-years
Hospital for Special Surgery Knee Score
(HSS) - validated outcome score
Measured: Preoperative
Hospital for Special Surgery Knee Score
(HSS) - validated outcome score
Measured: 6 month postoperative
Hospital for Special Surgery Knee Score
(HSS) - validated outcome score
Measured: annually through study completion, maximum of 10-years
Oxford Knee Score
(OKS) - validated outcome score
Measured: Preoperative
Oxford Knee Score
(OKS) - validated outcome score
Measured: 6 month postoperative
Oxford Knee Score
(OKS) - validated outcome score
Measured: annually through study completion, maximum of 10-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Jun 2011
- Primary completion31 Dec 2033 (estimated)
- Study completion1 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by ExactechThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788757
- Sponsor's protocol ID
- CR05-007
- Status last verified
- Jun 2024
- First submitted
- 9 Mar 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
- ClinicalTrials.gov ID
- NCT05788757
- Acronym / sponsor ID
- CR05-007
- Conditions
- Knee Arthroplasty, Total
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,588 participants (estimated)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 1 Jun 2034 (estimated)
- First posted
- 29 Mar 2023 (actual)
- 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.
A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
Detailed description
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Optetrak® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Subjects | – | Device: Optetrak Total Knee SystemPatients recruited from the population undergoing knee arthroplasty as part of standard of care. Patients who meet all the inclusion criteria and none of the exclusion criteria should be presented with an opportunity to undergo the informed consent process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must qualify for surgery per indications and contraindications as well as meet all the inclusion criteria and none of the exclusion criteria. The decision to offer a patient enrollment in this study is left to the discretion of the surgeon.
Key inclusion criteria (3 listed)
- Patient is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech
- Patient is skeletally mature
- Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary
Key exclusion criteria (6 listed)
- 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
- Patient has a mental or physical condition that may invalidate evaluation of the data - ---
- Patient is a prisoner
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 Total Knee SystemTotal Knee Arthroplasty using Exactech's Optetrak branded components. | Device | Enrolled Subjects |
Primary outcome
Knee Society Score
Time frame: Preoperative
(KSS) - validated outcome score
Knee Society Score
Time frame: 6 month postoperative
(KSS) - validated outcome score
Knee Society Score
Time frame: annually through study completion, maximum of 10-years
(KSS) - validated outcome score
Hospital for Special Surgery Knee Score
Time frame: Preoperative
(HSS) - validated outcome score
Hospital for Special Surgery Knee Score
Time frame: 6 month postoperative
(HSS) - validated outcome score
Hospital for Special Surgery Knee Score
Time frame: annually through study completion, maximum of 10-years
(HSS) - validated outcome score
Oxford Knee Score
Time frame: Preoperative
(OKS) - validated outcome score
Oxford Knee Score
Time frame: 6 month postoperative
(OKS) - validated outcome score
Oxford Knee Score
Time frame: annually through study completion, maximum of 10-years
(OKS) - validated outcome score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty, Total, run by Exactech at 3 sites 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 3 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Knee Society Score (time frame: Preoperative). The study lists 9 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 18 Jun 2024.