Post-traumatic OsteoarthritisNCT03257371
A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis
An observational study of Post-traumatic Osteoarthritis, run by James Stannard at 1 site in United States.
Trial summary
With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post-traumatic Osteoarthritis
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2016to Jul 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Who may be able to join
- Patient requiring repair via tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
- The subject is able and willing to consent to participate in the study
Who cannot join
- Acute injury to any other part of the affected lower extremity
- The subject is unwilling, or unable to consent due to psychiatric condition or legal incompetence
- BMI > 40
- Age > 50 at the time of enrollment
- The subject is either pregnant, or a prisoner
- Currently involved in a workers' compensation case at the time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Orthopaedic Institute
Columbia, Missouri, 65212
About this study
With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty will be enrolled in the study. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint as determined by physical examination, diagnostic imaging and knee arthroscopy by the PI. Exclusion criteria include Grade III or IV changes in any other compartment of the knee, acute injury to any other part of the affected lower extremity, or inability to comply with the protocol.
After enrollment, patients will undergo standardized knee radiography, and complete assessments (described below). Size-matched (standard clinical methodology) proximal tibia with meniscus and distal femur allografts from the same donor will be obtained from a tissue bank (Musculoskeletal Transplant Foundation, Edison, NJ) who has licensed the MOPS technology. The medial or lateral femoral condyle will be replaced using our novel instrumentation and technique described above. Tibial plateau-meniscus grafts will be trimmed and used to replace the entire medial or lateral tibial condyle while sparing the attachments of ACL, PCL and respective collateral ligament. The tibial plateau graft will be fixated using commercial available implants used for bone fixation. In the event that the meniscus has been detached from the tibial plateau during graft harvest, the periphery of the meniscus will be sutured to the capsule following standard meniscus transplant procedure.
Read more
Patients will undergo controlled post-operative rehabilitation according to standard protocols for osteochondral with concurrent meniscus allografts.
Range of motion, VAS pain score, SF-12, Tegner score, International Knee Documentation Committee (IKDC) subjective and objective scores, PROMIS Bank v1.2 - Physical Function-Mobility, PROMIS v1.1 - Global Health, PROMIS Bank v1.1- Pain Interference, PROMIS Bank v1.2 - Physical Function and Marx score as well as complete radiographs of the affected knee will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery to evaluate healing, function and evidence for arthrosis.
- Conditions
- Post-traumatic Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-traumatic knee OA | post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Pain Score
patient reported Visual Analogue Scale Pain Score, 0 no pain, 10 maximum pain
Measured: 12 months
Secondary outcomes (3)
Tegner Activity Level Scale
Patient reported outcome scale related to work and sporting activities, The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Measured: 12 months
International Knee Documentation Committee (IKDC) Total Score
Knee specific patient reported outcome, ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Measured: 12 months
PROMIS - Physical Function and Mobility
A survey related to physical function and mobility, T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
On the T-score metric:
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. A higher score is better for this outcome measure as it indicates more function/mobility compared to the mean of the reference population.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start30 Dec 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-traumatic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Stannard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, James Stannard, University of Missouri-Columbia
- Investigators
- James Stannard, MD, Principal investigator, University of Missouri, Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257371
- Sponsor's protocol ID
- 2002751
- Status last verified
- Jan 2021
- First submitted
- 18 Aug 2017
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03257371
- Acronym / sponsor ID
- 2002751
- Conditions
- Post-traumatic Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- James StannardUniversity, hospital or other
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Posted 26 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty will be enrolled in the study. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint as determined by physical examination, diagnostic imaging and knee arthroscopy by the PI. Exclusion criteria include Grade III or IV changes in any other compartment of the knee, acute injury to any other part of the affected lower extremity, or inability to comply with the protocol.
After enrollment, patients will undergo standardized knee radiography, and complete assessments (described below). Size-matched (standard clinical methodology) proximal tibia with meniscus and distal femur allografts from the same donor will be obtained from a tissue bank (Musculoskeletal Transplant Foundation, Edison, NJ) who has licensed the MOPS technology. The medial or lateral femoral condyle will be replaced using our novel instrumentation and technique described above. Tibial plateau-meniscus grafts will be trimmed and used to replace the entire medial or lateral tibial condyle while sparing the attachments of ACL, PCL and respective collateral ligament. The tibial plateau graft will be fixated using commercial available implants used for bone fixation. In the event that the meniscus has been detached from the tibial plateau during graft harvest, the periphery of the meniscus will be sutured to the capsule following standard meniscus transplant procedure.
Patients will undergo controlled post-operative rehabilitation according to standard protocols for osteochondral with concurrent meniscus allografts.
Range of motion, VAS pain score, SF-12, Tegner score, International Knee Documentation Committee (IKDC) subjective and objective scores, PROMIS Bank v1.2 - Physical Function-Mobility, PROMIS v1.1 - Global Health, PROMIS Bank v1.1- Pain Interference, PROMIS Bank v1.2 - Physical Function and Marx score as well as complete radiographs of the affected knee will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery to evaluate healing, function and evidence for arthrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-traumatic knee OA | – | –post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Key inclusion criteria (2 listed)
- Patient requiring repair via tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
- The subject is able and willing to consent to participate in the study
Key exclusion criteria (6 listed)
- Acute injury to any other part of the affected lower extremity
- The subject is unwilling, or unable to consent due to psychiatric condition or legal incompetence
- BMI > 40
- Age > 50 at the time of enrollment
- The subject is either pregnant, or 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.
Primary outcome
Visual Analogue Scale Pain Score
Time frame: 12 months
patient reported Visual Analogue Scale Pain Score, 0 no pain, 10 maximum pain
3 secondary outcomes
Tegner Activity Level Scale
Time frame: 12 months
International Knee Documentation Committee (IKDC) Total Score
Time frame: 12 months
PROMIS - Physical Function and Mobility
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James Stannard, MD principal investigator
University of Missouri, Department of Orthopaedic Surgery
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 Post-traumatic Osteoarthritis, run by James Stannard 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 2 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: finished, as of the sponsor's last update on 26 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analogue Scale Pain Score (time frame: 12 months). 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 26 Jan 2021.