An interventional study of Intraoperative application of CTM Flow and CTM Thick and Total knee arthroplasty (TKA) in Total Knee Arthroplasty and Knee Osteoarthristis, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Not yet recruiting. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Not applicable, Interventional, and Treatment
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).
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) is the lead sponsor of 49 studies on the registry; 20 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo standard of care total knee replacement.
Procedure: Total knee arthroplasty (TKA)
Patients will be treated with a perinatal derivative injection and patch during standard of care total knee replacement.
Biological: Intraoperative application of CTM Flow and CTM Thick · Procedure: Total knee arthroplasty (TKA)
Perinatal derivative connective tissue allograft
Also known as: CTM Flow, CTM Thick
Standard of care total knee arthroplasty (TKA)
Also known as: Total knee replacement
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Month 3
Time frame: Baseline and Month 3
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)