Total Knee ArthroplastyNCT07908342
Application of Perinatal Derivatives in Total Knee Arthroplasty
A study testing Intraoperative application of CTM Flow and CTM Thick and Total knee arthroplasty (TKA) in people with Total Knee Arthroplasty and Knee Osteoarthristis, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
Trial summary
This pilot study investigators whether the use of perinatal derivatives during knee replacement, in the form of an injection around the joint and patch over the knee joint incision, improves patient outcomes (including survey-based measures, functional outcomes and wound healing). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Total Knee Arthroplasty, Knee Osteoarthristis
- What is being tested?
- Intraoperative application of CTM Flow and CTM Thick and Total knee arthroplasty (TKA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 40 and 75 years of age
- Patients who are medically cleared and scheduled for unilateral primary total knee replacement
- No focal neurologic deficit of the surgical lower extremity
- Cognitively intact with the ability to sign informed consent
Who cannot join
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.
- Body mass index (BMI) > 40 kg/m2
- Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib
- Major systemic medical problems such as:
- Severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2
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- Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart Association (NYHA) class III-IV
- Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
- Impaired cognitive function or inability to understand the study protocol
- Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy [platelets < 100,000, International Normalized Ratio (INR) >1.5], refusal, etc.).
- Previous contralateral knee replacement managed with regional or periarticular injection
- Unable to follow-up at the one year interval at Allegheny Health Network
- Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Application of Perinatal Derivatives in Total Knee Arthroplasty: A Pilot Study
This pilot study investigators whether the use of perinatal derivatives during knee replacement, in the form of an injection around the joint and patch over the knee joint incision, improves patient outcomes (including survey-based measures, functional outcomes and wound healing). Perinatal derivatives are materials derived from donor placental tissue, including amnion, chorion and umbilical cord. The perinatal derivatives used in this study do not contain living cells.
Forty-eight patients aged 40 to 75 years undergoing knee replacement will be enrolled in this study and randomized to either receive or not receive perinatal derivatives during knee replacement. Participants will follow-up in clinic at Week 2, Week 6 and Month 3 after surgery. An additional remote visit will be conducted at Year 1 after surgery. Outcomes that will be assessed include the visual analogue scale (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Knee Score (OKS) and wound healing (using a standard wound healing assessment).
- Conditions
- Total Knee Arthroplasty, Knee Osteoarthristis
- Being tested
- Intraoperative application of CTM Flow and CTM Thick, Total knee arthroplasty (TKA)
- Keywords
- Total Knee Arthroplasty, TKA, Perinatal Derivative, CTM, PnD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative application of CTM Flow and CTM ThickBiological
Also called CTM Flow, CTM Thick
Perinatal derivative connective tissue allograft
Total knee arthroplasty (TKA)Procedure or surgery
Also called Total knee replacement
Standard of care total knee arthroplasty (TKA)
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Replacement | Active comparator | Patients will undergo standard of care total knee replacement. Receives: Procedure: Total knee arthroplasty (TKA) |
| Total Knee Replacement with CTM | Experimental | Patients will be treated with a perinatal derivative injection and patch during standard of care total knee replacement. Receives: Biological: Intraoperative application of CTM Flow and CTM Thick; Procedure: Total knee arthroplasty (TKA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Month 3
Measured: Baseline and Month 3
Secondary outcomes (6)
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 2, Week 6 and Year 1
Measured: Baseline, Week 2, Week 6 and Year 1
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) Score at Week 2, Week 6, Month 3 and Year 1
Measured: Baseline, Week 2, Week 6, Month 3 and Year 1
Change from Baseline in Visual Analog Scale (VAS) Score for Pain at Week 2, Week 6, Month 3 and Year 1
Measured: Baseline, Week 2, Week 6, Month 3 and Year 1
Change from Baseline in Oxford Knee Score (OKS) at Week 6, Month 3 and Year 1
Measured: Baseline, Week 6, Month 3 and Year 1
Change from Baseline in Range of Motion
Measured: Baseline, Week 2, Week 6 and Month 3
SMARrt Wound Tool
Measured: Week 2, Week 6 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- CTM Biomedical
- Responsible party
- Principal investigator, Brian Moore, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Brian F. Moore, M.D., Principal investigator, Department of Orthopaedics, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908342
- Sponsor's protocol ID
- CTM TKA
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Perinatal Derivatives in Total Knee Arthroplasty: A Pilot Study
- ClinicalTrials.gov ID
- NCT07908342
- Acronym / sponsor ID
- CTM TKA
- Conditions
- Total Knee Arthroplasty, Knee Osteoarthristis
- Keywords
- Total Knee Arthroplasty, TKA, Perinatal Derivative, CTM, PnD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- CTM Biomedical
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Nov 2026 (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.
This pilot study investigators whether the use of perinatal derivatives during knee replacement, in the form of an injection around the joint and patch over the knee joint incision, improves patient outcomes (including survey-based measures, functional outcomes and wound healing). Perinatal derivatives are materials derived from donor placental tissue, including amnion, chorion and umbilical cord. The perinatal derivatives used in this study do not contain living cells.
Forty-eight patients aged 40 to 75 years undergoing knee replacement will be enrolled in this study and randomized to either receive or not receive perinatal derivatives during knee replacement. Participants will follow-up in clinic at Week 2, Week 6 and Month 3 after surgery. An additional remote visit will be conducted at Year 1 after surgery. Outcomes that will be assessed include the visual analogue scale (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Knee Score (OKS) and wound healing (using a standard wound healing assessment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Knee Replacement | Active comparator | Procedure: Total knee arthroplasty (TKA)Patients will undergo standard of care total knee replacement. |
| Total Knee Replacement with CTM | Experimental | Biological: Intraoperative application of CTM Flow and CTM Thick, Procedure: Total knee arthroplasty (TKA)Patients will be treated with a perinatal derivative injection and patch during standard of care total knee replacement. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 40 and 75 years of age
- Patients who are medically cleared and scheduled for unilateral primary total knee replacement
- No focal neurologic deficit of the surgical lower extremity
- Cognitively intact with the ability to sign informed consent
Key exclusion criteria (13 listed)
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.
- Body mass index (BMI) > 40 kg/m2
- Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib
- Major systemic medical problems such as:
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 |
|---|---|---|
| Intraoperative application of CTM Flow and CTM ThickAlso: CTM Flow, CTM ThickPerinatal derivative connective tissue allograft | Biological | Total Knee Replacement with CTM |
| Total knee arthroplasty (TKA)Also: Total knee replacementStandard of care total knee arthroplasty (TKA) | Procedure or surgery | Total Knee Replacement, Total Knee Replacement with CTM |
Primary outcome
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Month 3
Time frame: Baseline and Month 3
6 secondary outcomes
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 2, Week 6 and Year 1
Time frame: Baseline, Week 2, Week 6 and Year 1
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) Score at Week 2, Week 6, Month 3 and Year 1
Time frame: Baseline, Week 2, Week 6, Month 3 and Year 1
Change from Baseline in Visual Analog Scale (VAS) Score for Pain at Week 2, Week 6, Month 3 and Year 1
Time frame: Baseline, Week 2, Week 6, Month 3 and Year 1
Change from Baseline in Oxford Knee Score (OKS) at Week 6, Month 3 and Year 1
Time frame: Baseline, Week 6, Month 3 and Year 1
Change from Baseline in Range of Motion
Time frame: Baseline, Week 2, Week 6 and Month 3
SMARrt Wound Tool
Time frame: Week 2, Week 6 and Month 3
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 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Brian F. Moore, M.D. principal investigator
Department of Orthopaedics, Allegheny Health Network
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative application of CTM Flow and CTM Thick and Total knee arthroplasty (TKA) in people with Total Knee Arthroplasty and Knee Osteoarthristis, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
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 13 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Clinical Research Coordinator (412-359-8292, mary.fetter@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Month 3 (time frame: Baseline and Month 3). 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 2026.