Knee Arthroplasty, TotalNCT05653102
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
An observational study of Knee Arthroplasty, Total, run by Exactech at 5 sites in United States.
Trial summary
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® 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?
- Truliant Total Knee System
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Jan 2019to 31 Jul 2035
- 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: The Truliant® Femoral Components, Tibial Inserts, Patellar Component and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Truliant® Cemented Femoral Components, Tibial Inserts, Patellar Component and Tibial Trays are indicated for cemented use only. The Truliant® Porous Femoral Components are indicated for cemented or cementless use. The Truliant® Porous Tibial Trays are indicated for cemented or cementless use. Patients must qualify for surgery per indications and contraindications as well as meet all of 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
- Cohort 1. Prospective / Subjects- Enrolled in the study pre-surgery
- Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
- Skeletally mature (18 years of age or older).
- Subject is willing and able to provide written informed consent for participation in the study.
- Subject is to receive a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee.
- The knee replacement will be performed by the investigator or a surgeon sub-investigator.
Show all 46Show fewer
- The devices will be used according to the approved indications.
- Cohort 2. Retrospective to Prospective / Subjects enrolled in the study post- surgery then continue to participate in the study prospectively.
- Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively).
- Skeletally mature (18 years of age or older).
- Subject is willing and able to provide written informed consent for participation in the study.
- Subject received a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee.
- The knee replacement was performed by the investigator or a surgeon sub-investigator.
- The devices are/were used according to the approved indications.
- Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre-operative, operative, and applicable postoperative data available in the subject's medical records, related to the Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission: Pre-Operative:
- o Demographic Data
- Gender
- Age at surgery
- Height/Weight
- Indication for surgery
- Prior Injuries/Surgeries on index knee
- Comorbidities
- Operative:
- Date of Surgery
- Type of Surgery (Primary / Revision)
- All component product information, including catalogue reference numbers
- Adverse Event Information, if applicable
- Cohort 3. Retrospective Only Subjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Note: No prospective data may be collected from a subject if they are enrolled under this cohort unless the subject is willing and able to provide written informed consent for participation in the study.
- Skeletally mature at the time of the surgery (18 years of age or older).
- The patient's clinical record includes a signed HIPAA waiver allowing for the use of clinical record data for the purpose of clinical research outside of the operating institution.
- The patients clinical record includes a documented procedure that includes, or is related to, TKA with a Truliant® Knee system device.
- The knee replacement was performed by the investigator or a surgeon sub-investigator.
- The devices are/were used according to the approved indications.
- Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria and have a minimum of the following pre-operative, operative, and applicable postoperative data available in the subject's medical records, related to the Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for submission:
- Pre-Operative:
- Demographic Data
- Gender
- Age at surgery
- Height/Weight
- Indication for surgery
- Prior Injuries/Surgeries on index knee
- Comorbidities
- Operative:
- Date of Surgery
- Type of Surgery (Primary / Revision)
- All component product information, including catalogue reference numbers Adverse Event Information, if applicable
Who cannot join
- Patient was <18 years of age at time of surgery
- Patient does not meet indicated population for use criteria for this device
- Patient is pregnant
- Patient is a prisoner
- Patient has a physical or mental condition that would invalidate the results
- Patient is contraindicated for the surgery (e.g., metal allergy)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Crystal Clinic
Akron, Ohio, 44333
Ginny Texter
Ian Gradisar, MD
- Recruiting
University of Colorado Health
Aurora, Colorado, 80045
Frank Somoza
Michael Dayton, MD
- Recruiting
Medical University South Carolina
Charleston, South Carolina, 29425
Lisa Mock
Richard Friedman, MD
- Recruiting
Florida Research Associates
DeLand, Florida, 32720
Diane Martin
Mark Hollmann, MD
- Recruiting
Nevada Orthopaedic and Spine Center
Las Vegas, Nevada, 89128
Ronald Hillock, MD
Ronald Hillock, MD
About this study
Official title: CR17-003 Truliant Knee PMCF: A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® 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 Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Truliant Total Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truliant Total Knee SystemDevice
Total Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Subjects | Enrolled in the study pre-surgery. Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study. Receives: Device: Truliant Total Knee System | |
| Retrospective to Prospective | Subjects enrolled in the study post- surgery then continue to participate in the study prospectively. Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively). Receives: Device: Truliant Total Knee System | |
| Retrospective Only Subjects | Subjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Patient's clinical record includes a signed HIPAA waiver allowing for the use of clinical record data for the purpose of clinical research outside of the operating institution. Receives: Device: Truliant Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: Preoperative
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: 1 year
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: 2 year
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: 3 year
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: 4 year
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: 5 year
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: 6 year
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: 7 year
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: 8 year
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: 9 year
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
KOOS JR. - validated outcome score
Measured: 10 year
Oxford Knee Score
OKS - validated outcome score
Measured: Preoperative
Oxford Knee Score
OKS - validated outcome score
Measured: 1 year
Oxford Knee Score
OKS - validated outcome score
Measured: 2 year
Oxford Knee Score
OKS - validated outcome score
Measured: 3 year
Oxford Knee Score
OKS - validated outcome score
Measured: 4 year
Oxford Knee Score
OKS - validated outcome score
Measured: 5 year
Oxford Knee Score
OKS - validated outcome score
Measured: 6 year
Oxford Knee Score
OKS - validated outcome score
Measured: 7 year
Oxford Knee Score
OKS - validated outcome score
Measured: 8 year
Oxford Knee Score
OKS - validated outcome score
Measured: 9 year
Oxford Knee Score
OKS - validated outcome score
Measured: 10 year
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: Preoperative
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 6-weeks
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 6-months
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 1 year
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 2 year
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 3 year
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 4 year
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 5 year
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 6 year
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 7 year
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 8 year
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 9 year
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (high score is better)
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start23 Jan 2019
- Primary completion31 Jan 2035 (estimated)
- Study completion31 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653102
- Sponsor's protocol ID
- CR17-003
- Status last verified
- Jun 2024
- First submitted
- 1 Dec 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Meftah M, White PB, Ranawat AS, Ranawat CS. Long-term results of total knee arthroplasty in young and active patients with posterior stabilized design. Knee. 2016 Mar;23(2):318-21. doi: 10.1016/j.knee.2015.10.008. Epub 2016 Jan 29.
PubMed 26833096Scott CE, Clement ND, MacDonald DJ, Hamilton DF, Gaston P, Howie CR, Burnett R. Five-year survivorship and patient-reported outcome of the Triathlon single-radius total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1676-83. doi: 10.1007/s00167-014-2922-8. Epub 2014 Mar 13.
PubMed 24623184Martin A, Quah C, Syme G, Lammin K, Segaren N, Pickering S. Long term survivorship following Scorpio Total Knee Replacement. Knee. 2015 Jun;22(3):192-6. doi: 10.1016/j.knee.2015.01.007. Epub 2015 Mar 26.
PubMed 25818502
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
- CR17-003 Truliant Knee PMCF: A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
- ClinicalTrials.gov ID
- NCT05653102
- Acronym / sponsor ID
- CR17-003
- Conditions
- Knee Arthroplasty, Total
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 31 Jan 2035 (estimated)
- Study completion
- 31 Jul 2035 (estimated)
- First posted
- 16 Dec 2022 (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 Truliant® 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 Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective Subjects | – | Device: Truliant Total Knee SystemEnrolled in the study pre-surgery. Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study. |
| Retrospective to Prospective | – | Device: Truliant Total Knee SystemSubjects enrolled in the study post- surgery then continue to participate in the study prospectively. Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively). |
| Retrospective Only Subjects | – | Device: Truliant Total Knee SystemSubjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Patient's clinical record includes a signed HIPAA waiver allowing for the use of clinical record data for the purpose of clinical research outside of the operating institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Truliant® Femoral Components, Tibial Inserts, Patellar Component and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Truliant® Cemented Femoral Components, Tibial Inserts, Patellar Component and Tibial Trays are indicated for cemented use only. The Truliant® Porous Femoral Components are indicated for cemented or cementless use. The Truliant® Porous Tibial Trays are indicated for cemented or cementless use. Patients must qualify for surgery per indications and contraindications as well as meet all of 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 (46 listed)
- Cohort 1. Prospective / Subjects- Enrolled in the study pre-surgery
- Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
- Skeletally mature (18 years of age or older).
- Subject is willing and able to provide written informed consent for participation in the study.
- Subject is to receive a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee.
Key exclusion criteria (6 listed)
- Patient was <18 years of age at time of surgery
- Patient does not meet indicated population for use criteria for this device
- Patient is pregnant
- Patient is a prisoner
- Patient has a physical or mental condition that would invalidate the results
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 |
|---|---|---|
| Truliant Total Knee SystemTotal Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components. | Device | Prospective Subjects, Retrospective Only Subjects, Retrospective to Prospective |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: Preoperative
KOOS JR. - validated outcome score
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: 1 year
KOOS JR. - validated outcome score
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: 2 year
KOOS JR. - validated outcome score
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: 3 year
KOOS JR. - validated outcome score
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: 4 year
KOOS JR. - validated outcome score
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: 5 year
KOOS JR. - validated outcome score
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: 6 year
KOOS JR. - validated outcome score
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: 7 year
KOOS JR. - validated outcome score
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: 8 year
KOOS JR. - validated outcome score
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: 9 year
KOOS JR. - validated outcome score
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Time frame: 10 year
KOOS JR. - validated outcome score
Oxford Knee Score
Time frame: Preoperative
OKS - validated outcome score
Oxford Knee Score
Time frame: 1 year
OKS - validated outcome score
Oxford Knee Score
Time frame: 2 year
OKS - validated outcome score
Oxford Knee Score
Time frame: 3 year
OKS - validated outcome score
Oxford Knee Score
Time frame: 4 year
OKS - validated outcome score
Oxford Knee Score
Time frame: 5 year
OKS - validated outcome score
Oxford Knee Score
Time frame: 6 year
OKS - validated outcome score
Oxford Knee Score
Time frame: 7 year
OKS - validated outcome score
Oxford Knee Score
Time frame: 8 year
OKS - validated outcome score
Oxford Knee Score
Time frame: 9 year
OKS - validated outcome score
Oxford Knee Score
Time frame: 10 year
OKS - validated outcome score
Visual Analog Scale (VAS) - Pain
Time frame: Preoperative
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 6-weeks
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 6-months
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 1 year
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 2 year
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 3 year
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 4 year
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 5 year
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 6 year
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 7 year
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 8 year
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 9 year
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 10 year
Visual scale from 1-10 (high score is better)
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.
- Results publication: PubMed 26833096Meftah M, White PB, Ranawat AS, Ranawat CS. Long-term results of total knee arthroplasty in young and active patients with posterior stabilized design. Knee. 2016 Mar;23(2):318-21. doi: 10.1016/j.knee.2015.10.008. Epub 2016 Jan 29.
- Results publication: PubMed 24623184Scott CE, Clement ND, MacDonald DJ, Hamilton DF, Gaston P, Howie CR, Burnett R. Five-year survivorship and patient-reported outcome of the Triathlon single-radius total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1676-83. doi: 10.1007/s00167-014-2922-8. Epub 2014 Mar 13.
- Results publication: PubMed 25818502Martin A, Quah C, Syme G, Lammin K, Segaren N, Pickering S. Long term survivorship following Scorpio Total Knee Replacement. Knee. 2015 Jun;22(3):192-6. doi: 10.1016/j.knee.2015.01.007. Epub 2015 Mar 26.
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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.
5 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 5 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 46 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: looking for participants now, 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 5 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?
Contact Pearl Harris (352-327-4846, pearl.harris@exac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. (time frame: Preoperative). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05653102, which also lists 3 linked publications.
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.