Mild to Moderate Knee OANCT03125499
A Prospective Observational Study to Evaluate Long-term Changes in Cartilage Morphology in Subjects Who Previously Received TPX-100 or Placebo in Study TPX-100-1 for Patellar Osteoarthritis Involving Both Knees
An observational study of Mild to Moderate Knee OA, run by OrthoTrophix, Inc at 1 site in United States.
Trial summary
To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Mild to Moderate Knee OA
- What is being tested?
- Previous treated with TPX-100
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2017to 1 Mar 2018
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with bi-lateral knee OA that have previous been treated in TPX-100-1 or TPX-100-2
Who may be able to join
- Subjects who participated in TPX-100-1 and received 4 injections of 200 mg/injection TPX-100 in one knee, or subjects who participated in TPX-100
- Cruciate and collateral ligament stability as assessed by screening history and clinical examination
- Stable medial and lateral menisci as assessed by screening history and clinical examination
- Able to read, understand, sign and date the subject informed consent
Who cannot join
- Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight > 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
- Prior surgery in the knees, excluding procedures for debridement only (no previous microfracture procedure)
- History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
- Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before enrollment
- Last intra-articular knee injection of corticosteroids < 3 months before enrollment
- Use of any steroids (except inhaled corticosteroids for allergy or respiratory problems) during the previous month before enrollment
Show all 11Show fewer
- History of arthroscopy in either knee in the 3 months before enrollment
- History of septic arthritis, gout or pseudo-gout in either knee in the 12 months before enrollment
- Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
- Active systemic infection
- Participation in other clinical osteoarthritis drug studies, except for studies TPX-100-1 and TPX-100-2, within two years prior to enrollment in TPX-100-4.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.
Read the detailed description
No drug intervention. Study to collect 1 additional MRI of each knee treated in either TPX-100-1 or TPX-100-2.
- Conditions
- Mild to Moderate Knee OA
- Being tested
- Previous treated with TPX-100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previous treated with TPX-100Other
Also called AC-100
No intervention, only observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the long-term changes in patellar cartilage thickness
Quantitative analysis of long-term changes in patellar cartilage thickness by MRI
Measured: Between 24 and 34 months from initial drug treatment
Secondary outcomes (3)
Examine intra-subject longitudinal changes in patellar cartilage volume between TPX-100 versus placebo-treated knees by MRI
Examine intra-subject longitudinal changes in patellar cartilage volume between TPX-100 versus placebo-treated knees by MRI
Measured: Between 24 and 34 months from initial drug treatment
Examine intra-subject longitudinal changes in thickness and thinness scores of cartilage in the central (non-patellar) compartment of knees
Examine intra-subject longitudinal changes in thickness and thinness scores of cartilage in the central (non-patellar) compartment of knees
Measured: Between 24 and 34 months from initial drug treatment
Examine intra-subject longitudinal changes in Patient reported outcome measures
Examine intra-subject longitudinal changes in Patient Reported Outcome Measures
Measured: Between 24 and 34 months from initial drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start27 Jul 2017
- Primary completion1 Oct 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Knee OAStudies 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
- Other
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoTrophix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125499
- Sponsor's protocol ID
- TPX-100-4
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2017
- Last updated
- 5 Apr 2018
- 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 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate Long-term Changes in Cartilage Morphology in Subjects Who Previously Received TPX-100 or Placebo in Study TPX-100-1 for Patellar Osteoarthritis Involving Both Knees
- ClinicalTrials.gov ID
- NCT03125499
- Acronym / sponsor ID
- TPX-100-4
- Conditions
- Mild to Moderate Knee OA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- OrthoTrophix, IncIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 24 Apr 2017 (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.
To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.
Detailed description
No drug intervention. Study to collect 1 additional MRI of each knee treated in either TPX-100-1 or TPX-100-2.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with bi-lateral knee OA that have previous been treated in TPX-100-1 or TPX-100-2
Key inclusion criteria (4 listed)
- Subjects who participated in TPX-100-1 and received 4 injections of 200 mg/injection TPX-100 in one knee, or subjects who participated in TPX-100
- Cruciate and collateral ligament stability as assessed by screening history and clinical examination
- Stable medial and lateral menisci as assessed by screening history and clinical examination
- Able to read, understand, sign and date the subject informed consent
Key exclusion criteria (11 listed)
- Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight > 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
- Prior surgery in the knees, excluding procedures for debridement only (no previous microfracture procedure)
- History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
- Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before enrollment
- Last intra-articular knee injection of corticosteroids < 3 months before 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 |
|---|---|---|
| Previous treated with TPX-100Also: AC-100No intervention, only observational | Other | – |
Primary outcome
Evaluate the long-term changes in patellar cartilage thickness
Time frame: Between 24 and 34 months from initial drug treatment
Quantitative analysis of long-term changes in patellar cartilage thickness by MRI
3 secondary outcomes
Examine intra-subject longitudinal changes in patellar cartilage volume between TPX-100 versus placebo-treated knees by MRI
Time frame: Between 24 and 34 months from initial drug treatment
Examine intra-subject longitudinal changes in thickness and thinness scores of cartilage in the central (non-patellar) compartment of knees
Time frame: Between 24 and 34 months from initial drug treatment
Examine intra-subject longitudinal changes in Patient reported outcome measures
Time frame: Between 24 and 34 months from initial drug treatment
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 5 Apr 2018.
- 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 Mild to Moderate Knee OA, run by OrthoTrophix, Inc 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 4 inclusion and 11 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 5 Apr 2018. 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?
Evaluate the long-term changes in patellar cartilage thickness (time frame: Between 24 and 34 months from initial drug treatment). 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 5 Apr 2018.