Knee OsteoarthritisNCT03719417
A Biologic Joint Replacement Strategy for Knee Trauma and Post-Traumatic Osteoarthritis
A study testing Unicompartmental Biologic Arthroplasty and Extensive Biologic Arthroplasty in people with Knee Osteoarthritis and Post-traumatic Osteoarthritis, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Participants will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Knee Osteoarthritis, Post-traumatic Osteoarthritis
- What is being tested?
- Unicompartmental Biologic Arthroplasty and Extensive Biologic Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 31 Oct 2022
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint (unicompartmental) or unicompartmental and other femoral condyle, tibial plateau, trochlea and/or patella.
- Between the age of 18-55
Who cannot join
- Acute injury to any other part of the affected lower extremity
- Inability to comply with protocol
- BMI greater than 40
- The subject is either pregnant or a prisoner
- Currently involved in worker's compensation case at the time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Orthopaedic Institute
Columbia, Missouri, 65202
About this study
Official title: A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Osteoarthritis (Expansion)
Participants will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation.
Read the detailed description
With IRB approval, patients will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation. Demographic and operative data will be collected. Outcome assessments will include VAS pain, IKDC, SANE, Tegner and PROMIS Mobility for knee at 6 months and yearly after surgery. In addition, serial limb alignment measurements, ultrasonographic assessments of meniscal location and integrity, quantitative MRIs for cartilage composition, and serum and urine biomarkers for treatment monitoring will be performed. All complications and re-operations will be recorded. OCA survival will be determined based on maintenance of acceptable levels of pain and function and/or need for revision surgery or total knee arthroplasty.
- Conditions
- Knee Osteoarthritis, Post-traumatic Osteoarthritis
- Being tested
- Unicompartmental Biologic Arthroplasty, Extensive Biologic Arthroplasty
- Keywords
- Knee Pain
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicompartmental Biologic ArthroplastyProcedure or surgery
Unicompartmental Biologic Arthroplasty surgery.
Extensive Biologic ArthroplastyProcedure or surgery
Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently
| Study group | Role | What they receive |
|---|---|---|
| Unicompartmental Biologic Arthroplasty | Active comparator | Subject will be receiving a unicompartmental biologic arthroplasty only Receives: Procedure: Unicompartmental Biologic Arthroplasty |
| Extensive Biologic Arthroplasty | Active comparator | Subject will be receiving a unicompartmental biologic arthroplasty with at least one additional surface in another compartment being replaced concurrently. Receives: Procedure: Extensive Biologic Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Pain Score (Visual Analog Scale)
This pain score is between 0 and 10, with 0 being no pain and 10 being the worst pain
Measured: 12 Months
Secondary outcomes (3)
International Knee Documentation Committee Score (IKDC)
This score looks at pain and function scores. 0 is the lowest score and 100 is the highest function score.
Measured: 12 Months
Single Assessment Numeric Evaluation (SANE) score
This score looks at what the patient rates their knee with 100% being normal, and 0% being as far from normal as possible
Measured: 12 Months
PROMIS Mobility
This looks at mobility and function on a scale of 14.1 to 61.7 with higher scores equaling higher mobility
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 posted25 Oct 2018
- Study start1 Dec 2018
- Primary completion1 Jun 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT03719417
- Sponsor's protocol ID
- 2011153
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2018
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. 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 Osteoarthritis (Expansion)
- ClinicalTrials.gov ID
- NCT03719417
- Acronym / sponsor ID
- 2011153
- Conditions
- Knee Osteoarthritis, Post-traumatic Osteoarthritis
- Keywords
- Knee Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 25 Oct 2018 (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.
Participants will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation.
Detailed description
With IRB approval, patients will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation. Demographic and operative data will be collected. Outcome assessments will include VAS pain, IKDC, SANE, Tegner and PROMIS Mobility for knee at 6 months and yearly after surgery. In addition, serial limb alignment measurements, ultrasonographic assessments of meniscal location and integrity, quantitative MRIs for cartilage composition, and serum and urine biomarkers for treatment monitoring will be performed. All complications and re-operations will be recorded. OCA survival will be determined based on maintenance of acceptable levels of pain and function and/or need for revision surgery or total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unicompartmental Biologic Arthroplasty | Active comparator | Procedure: Unicompartmental Biologic ArthroplastySubject will be receiving a unicompartmental biologic arthroplasty only |
| Extensive Biologic Arthroplasty | Active comparator | Procedure: Extensive Biologic ArthroplastySubject will be receiving a unicompartmental biologic arthroplasty with at least one additional surface in another compartment being replaced concurrently. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint (unicompartmental) or unicompartmental and other femoral condyle, tibial plateau, trochlea and/or patella.
- Between the age of 18-55
Key exclusion criteria (5 listed)
- Acute injury to any other part of the affected lower extremity
- Inability to comply with protocol
- BMI greater than 40
- The subject is either pregnant or a prisoner
- Currently involved in worker's compensation case at the time of enrollment
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 |
|---|---|---|
| Unicompartmental Biologic ArthroplastyUnicompartmental Biologic Arthroplasty surgery. | Procedure or surgery | Unicompartmental Biologic Arthroplasty |
| Extensive Biologic ArthroplastyUnicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently | Procedure or surgery | Extensive Biologic Arthroplasty |
Primary outcome
VAS Pain Score (Visual Analog Scale)
Time frame: 12 Months
This pain score is between 0 and 10, with 0 being no pain and 10 being the worst pain
3 secondary outcomes
International Knee Documentation Committee Score (IKDC)
Time frame: 12 Months
Single Assessment Numeric Evaluation (SANE) score
Time frame: 12 Months
PROMIS Mobility
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 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.
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?
A study testing Unicompartmental Biologic Arthroplasty and Extensive Biologic Arthroplasty in people with Knee Osteoarthritis and Post-traumatic Osteoarthritis, run by University of Missouri-Columbia 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 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: finished, as of the sponsor's last update on 2 Nov 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAS Pain Score (Visual Analog Scale) (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 2 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.