Osteoarthritis (OA) of the KneePhase 4NCT07775248
Novel Extended-Release Bupivacaine Polymer for Sustained Pain Relief Following Total Knee Arthroplasty
A Phase 4 study testing Periarticular Injection, Adductor Canal Block and Bupivacaine-Meloxicam in people with Osteoarthritis (OA) of the Knee, run by Henry Ford Health System at 1 site in United States.
Trial summary
Participants are being invited to take part in a research study about pain control after total knee replacement surgery (also called total knee arthroplasty or TKA). The goal of this study is to see if a new long-acting medication, called Zynrelef, can control pain after surgery as well as or better than two other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- Periarticular Injection, Adductor Canal Block and Bupivacaine-Meloxicam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 20 Oct 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients age 18 and older undergoing primary total knee replacement by fellowship trained Orthopedic Surgeons in Henry Ford Health System with planned outpatient same-day discharge.
Who cannot join
- Incomplete data in medical records
- Non-English speakers
- Chronic opioid use in the last 3 months
- Ipsilateral joint surgery in the last year
- Undergoing bilateral knee arthroplasty
- Cannot tolerate oral medications
Show all 16Show fewer
- Swallowing difficulties
- Intolerance to acetaminophen, anti-inflammatories, muscle relaxants, gabapentinoids, or opioids/tramadol
- History of alcohol abuse
- Drug abuse
- Renal impairment
- Peptic ulcer disease
- GI bleeding
- Illicit narcotic usage in the past 6 months
- Chronic liver disease
- Chronic pain syndromes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Medical Center - Grosse Pointe Cottage
Grosse Pointe Farms, Michigan, 48236
Trevor North, MD, 313 916 9388, tnorth1@hfhs.org
About this study
Participants are being invited to take part in a research study about pain control after total knee replacement surgery (also called total knee arthroplasty or TKA). The goal of this study is to see if a new long-acting medication, called Zynrelef, can control pain after surgery as well as or better than two other common pain treatments - a nerve block or a standard injection into the knee during surgery.
Knee replacement is done to reduce pain and improve movement in people with severe knee arthritis. While the surgery can be very successful, pain during the first few days after surgery can make recovery harder. Many patients need strong opioid pain medicines, but these medicines can have side effects and may lead to dependence. The investigators want to find ways to control pain that reduce or even remove the need for opioids.
Read more
If participants join this study, they will be randomly placed (like flipping a coin) into one of three groups:
Standard injection (PAI) - a mix of medicines injected into the knee during surgery.
Zynrelef - a new long-acting medicine put directly into the knee during surgery, along with a smaller dose of the standard injection.
Nerve block (ACB) - medicine given near a nerve in the leg before surgery to block pain.
All participants will get the same medicines before and after surgery, follow the same physical therapy program, and have the same follow-up visits. Participants will be asked to record their pain scores and the pain medicines they take for several weeks after surgery.
The risks of joining are small and similar to those of routine care. All three pain control methods are already used in regular knee replacement surgery. Possible side effects may include temporary numbness, weakness, or soreness from the injections, and the usual surgical risks such as infection.
Participants may benefit from better pain control, less need for opioids, and a smoother recovery. The results from this study may also help future patients have safer and more comfortable knee replacements.
Taking part is voluntary. Participants can leave the study at any time without affecting their medical care.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- Periarticular Injection, Adductor Canal Block, Bupivacaine-Meloxicam
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periarticular InjectionDrug
Also called Periarticular Injection (PAI)
Study group I (standard PAI) will receive an intraoperative periarticular injection consisting of 300mg of 0.5% ropivacaine with 1mg epinephrine and 30mg ketorolac in sodium chloride 0.9% diluted to a volume of 120ml.
Adductor Canal BlockDrug
Also called Saphenous Nerve Block, Subsartorial Block
Patients randomized to the adductor canal block (ACB) arm will receive a preoperative ACB administered by an anesthesia provider prior to total knee arthroplasty, with additional ropivacaine administered to the posterior capsule per standard protocol.
Bupivacaine-MeloxicamDrug
Also called Zynrelef
will receive the extended-release bupivacaine injected into the effective knee joint space prior to closure, combined with an abbreviated PAI of half dose (150mg ropivacaine) to act as a bridge per standard recommendation.
| Study group | Role | What they receive |
|---|---|---|
| Periarticular Injection | Active comparator | Study group I (standard PAI) will receive an intraoperative periarticular injection consisting of 300mg of 0.5% ropivacaine with 1mg epinephrine and 30mg ketorolac in sodium chloride 0.9% diluted to a volume of 120ml. Receives: Drug: Periarticular Injection |
| Adductor Canal Block | Active comparator | (adductor canal block) will receive an adductor canal block in the preoperative bay. Receives: Drug: Adductor Canal Block |
| Bupivacaine-Meloxicam | Active comparator | will receive the extended-release bupivacaine injected into the effective knee joint space prior to closure, combined with an abbreviated PAI of half dose (150mg ropivacaine) to act as a bridge per standard recommendation. Receives: Drug: Bupivacaine-Meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score Assessed Using the Numeric Rating Scale (NRS)
Postoperative pain will be assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain outcomes. Pain scores will be recorded daily by participants from postoperative day 0 through postoperative day 5.
Measured: Postoperative Day 0-Postoperative Day 5
Secondary outcomes (9)
Emergency Department Visits
Any unplanned emergency department visit occurring within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Measured: 90 days post-op
Mortality
Any cause of death occurring within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Measured: 90 days post-op
Postoperative Unplanned Readmission
Any unplanned hospital readmission occurring within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Measured: 90 days post-op
Return to Operating Room
Any unplanned return to the operating room for any reason within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Measured: 90 days post-op
Number of Participants with Hardware Failure of Implanted Prosthetic Components
Any mechanical failure of implanted prosthetic components, including loosening, breakage, or malposition, occurring within 90 days of total knee arthroplasty, as identified through chart review and imaging.
Measured: 90 days post-op
Number of Participants with Periprosthetic or Perioperative Fracture
Any periprosthetic or perioperative fracture occurring within 90 days of total knee arthroplasty, as identified through chart review and imaging.
Measured: 90 days post-op
Number of Participants with Postoperative Dislocation of the Prosthetic Joint
Any dislocation of the prosthetic joint occurring within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Measured: 90 days post-op
Number of Participants with Periprosthetic Joint Infection (PJI)
Any prosthetic joint infection diagnosed within 90 days of total knee arthroplasty per established diagnostic criteria, as identified through chart review, laboratory findings, and the electronic medical record.
Measured: 90 days post-op
Number of Participants with Postoperative Hematoma
Any hematoma formation at the surgical site requiring clinical intervention or documentation within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Measured: 90 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start11 Feb 2025
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Trevor North, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775248
- Sponsor's protocol ID
- 17228-09
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.
PubMed 24793570Lee GC, Berkowitz R, Hacker S, Hu J, Rechter A. HTX-011 in Combination with Multimodal Analgesic Regimen Minimized Severe Pain and Opioid Use after Total Knee Arthroplasty in an Open-Label Study. J Knee Surg. 2023 Jul;36(9):925-932. doi: 10.1055/s-0042-1747945. Epub 2022 Jun 10.
PubMed 35688442Lachiewicz PF, Lee GC, Pollak RA, Leiman DG, Hu J, Sah AP. HTX-011 Reduced Pain and Opioid Use After Primary Total Knee Arthroplasty: Results of a Randomized Phase 2b Trial. J Arthroplasty. 2020 Oct;35(10):2843-2851. doi: 10.1016/j.arth.2020.05.044. Epub 2020 May 27.
PubMed 32561266Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee GC. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019 May 21:rapm-2019-100531. doi: 10.1136/rapm-2019-100531. Online ahead of print.
PubMed 31113830Moutzouros V, Jildeh TR, Khalil LS, Schwartz K, Hasan L, Matar RN, Okoroha KR. A Multimodal Protocol to Diminish Pain Following Common Orthopedic Sports Procedures: Can We Eliminate Postoperative Opioids? Arthroscopy. 2020 Aug;36(8):2249-2257. doi: 10.1016/j.arthro.2020.04.018. Epub 2020 Apr 28.
PubMed 32353620Cho CH, Song KS, Min BW, Lee KJ, Ha E, Lee YC, Lee YK. Multimodal approach to postoperative pain control in patients undergoing rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1744-8. doi: 10.1007/s00167-010-1294-y. Epub 2010 Oct 19.
PubMed 20957469Fiore JF Jr, Olleik G, El-Kefraoui C, Verdolin B, Kouyoumdjian A, Alldrit A, Figueiredo AG, Valanci S, Marquez-GdeV JA, Schulz M, Moldoveanu D, Nguyen-Powanda P, Best G, Banks A, Landry T, Pecorelli N, Baldini G, Feldman LS. Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia. Br J Anaesth. 2019 Nov;123(5):627-636. doi: 10.1016/j.bja.2019.08.014. Epub 2019 Sep 25.
PubMed 31563269El-Kefraoui C, Olleik G, Chay MA, Kouyoumdjian A, Nguyen-Powanda P, Rajabiyazdi F, Do U, Derksen A, Landry T, Amar-Zifkin A, Ramanakumar AV, Martel MO, Baldini G, Feldman L, Fiore JF Jr. Opioid versus opioid-free analgesia after surgical discharge: protocol for a systematic review and meta-analysis. BMJ Open. 2020 Feb 2;10(1):e035443. doi: 10.1136/bmjopen-2019-035443.
PubMed 32014880Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.
PubMed 32530891Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132.
PubMed 28973092
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Extended-Release Bupivacaine Polymer for Sustained Pain Relief Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07775248
- Acronym / sponsor ID
- 17228-09
- Conditions
- Osteoarthritis (OA) of the Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 20 Aug 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.
Participants are being invited to take part in a research study about pain control after total knee replacement surgery (also called total knee arthroplasty or TKA). The goal of this study is to see if a new long-acting medication, called Zynrelef, can control pain after surgery as well as or better than two other common pain treatments - a nerve block or a standard injection into the knee during surgery.
Knee replacement is done to reduce pain and improve movement in people with severe knee arthritis. While the surgery can be very successful, pain during the first few days after surgery can make recovery harder. Many patients need strong opioid pain medicines, but these medicines can have side effects and may lead to dependence. The investigators want to find ways to control pain that reduce or even remove the need for opioids.
If participants join this study, they will be randomly placed (like flipping a coin) into one of three groups:
Standard injection (PAI) - a mix of medicines injected into the knee during surgery.
Zynrelef - a new long-acting medicine put directly into the knee during surgery, along with a smaller dose of the standard injection.
Nerve block (ACB) - medicine given near a nerve in the leg before surgery to block pain.
All participants will get the same medicines before and after surgery, follow the same physical therapy program, and have the same follow-up visits. Participants will be asked to record their pain scores and the pain medicines they take for several weeks after surgery.
The risks of joining are small and similar to those of routine care. All three pain control methods are already used in regular knee replacement surgery. Possible side effects may include temporary numbness, weakness, or soreness from the injections, and the usual surgical risks such as infection.
Participants may benefit from better pain control, less need for opioids, and a smoother recovery. The results from this study may also help future patients have safer and more comfortable knee replacements.
Taking part is voluntary. Participants can leave the study at any time without affecting their medical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periarticular Injection | Active comparator | Drug: Periarticular InjectionStudy group I (standard PAI) will receive an intraoperative periarticular injection consisting of 300mg of 0.5% ropivacaine with 1mg epinephrine and 30mg ketorolac in sodium chloride 0.9% diluted to a volume of 120ml. |
| Adductor Canal Block | Active comparator | Drug: Adductor Canal Block(adductor canal block) will receive an adductor canal block in the preoperative bay. |
| Bupivacaine-Meloxicam | Active comparator | Drug: Bupivacaine-Meloxicamwill receive the extended-release bupivacaine injected into the effective knee joint space prior to closure, combined with an abbreviated PAI of half dose (150mg ropivacaine) to act as a bridge per standard recommendation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients age 18 and older undergoing primary total knee replacement by fellowship trained Orthopedic Surgeons in Henry Ford Health System with planned outpatient same-day discharge.
Key exclusion criteria (16 listed)
- Incomplete data in medical records
- Non-English speakers
- Chronic opioid use in the last 3 months
- Ipsilateral joint surgery in the last year
- Undergoing bilateral knee arthroplasty
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 |
|---|---|---|
| Periarticular InjectionAlso: Periarticular Injection (PAI)Study group I (standard PAI) will receive an intraoperative periarticular injection consisting of 300mg of 0.5% ropivacaine with 1mg epinephrine and 30mg ketorolac in sodium chloride 0.9% diluted to a volume of 120ml. | Drug | Periarticular Injection |
| Adductor Canal BlockAlso: Saphenous Nerve Block, Subsartorial BlockPatients randomized to the adductor canal block (ACB) arm will receive a preoperative ACB administered by an anesthesia provider prior to total knee arthroplasty, with additional ropivacaine administered to the posterior capsule per standard protocol. | Drug | Adductor Canal Block |
| Bupivacaine-MeloxicamAlso: Zynrelefwill receive the extended-release bupivacaine injected into the effective knee joint space prior to closure, combined with an abbreviated PAI of half dose (150mg ropivacaine) to act as a bridge per standard recommendation. | Drug | Bupivacaine-Meloxicam |
Primary outcome
Postoperative Pain Score Assessed Using the Numeric Rating Scale (NRS)
Time frame: Postoperative Day 0-Postoperative Day 5
Postoperative pain will be assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain outcomes. Pain scores will be recorded daily by participants from postoperative day 0 through postoperative day 5.
9 secondary outcomes
Emergency Department Visits
Time frame: 90 days post-op
Mortality
Time frame: 90 days post-op
Postoperative Unplanned Readmission
Time frame: 90 days post-op
Return to Operating Room
Time frame: 90 days post-op
Number of Participants with Hardware Failure of Implanted Prosthetic Components
Time frame: 90 days post-op
Number of Participants with Periprosthetic or Perioperative Fracture
Time frame: 90 days post-op
Number of Participants with Postoperative Dislocation of the Prosthetic Joint
Time frame: 90 days post-op
Number of Participants with Periprosthetic Joint Infection (PJI)
Time frame: 90 days post-op
Number of Participants with Postoperative Hematoma
Time frame: 90 days post-op
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 20 Aug 2026.
- Background: PubMed 24793570Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.
- Background: PubMed 35688442Lee GC, Berkowitz R, Hacker S, Hu J, Rechter A. HTX-011 in Combination with Multimodal Analgesic Regimen Minimized Severe Pain and Opioid Use after Total Knee Arthroplasty in an Open-Label Study. J Knee Surg. 2023 Jul;36(9):925-932. doi: 10.1055/s-0042-1747945. Epub 2022 Jun 10.
- Background: PubMed 32561266Lachiewicz PF, Lee GC, Pollak RA, Leiman DG, Hu J, Sah AP. HTX-011 Reduced Pain and Opioid Use After Primary Total Knee Arthroplasty: Results of a Randomized Phase 2b Trial. J Arthroplasty. 2020 Oct;35(10):2843-2851. doi: 10.1016/j.arth.2020.05.044. Epub 2020 May 27.
- Background: PubMed 31113830Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee GC. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019 May 21:rapm-2019-100531. doi: 10.1136/rapm-2019-100531. Online ahead of print.
- Background: PubMed 32353620Moutzouros V, Jildeh TR, Khalil LS, Schwartz K, Hasan L, Matar RN, Okoroha KR. A Multimodal Protocol to Diminish Pain Following Common Orthopedic Sports Procedures: Can We Eliminate Postoperative Opioids? Arthroscopy. 2020 Aug;36(8):2249-2257. doi: 10.1016/j.arthro.2020.04.018. Epub 2020 Apr 28.
- Background: PubMed 20957469Cho CH, Song KS, Min BW, Lee KJ, Ha E, Lee YC, Lee YK. Multimodal approach to postoperative pain control in patients undergoing rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1744-8. doi: 10.1007/s00167-010-1294-y. Epub 2010 Oct 19.
- Background: PubMed 31563269Fiore JF Jr, Olleik G, El-Kefraoui C, Verdolin B, Kouyoumdjian A, Alldrit A, Figueiredo AG, Valanci S, Marquez-GdeV JA, Schulz M, Moldoveanu D, Nguyen-Powanda P, Best G, Banks A, Landry T, Pecorelli N, Baldini G, Feldman LS. Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia. Br J Anaesth. 2019 Nov;123(5):627-636. doi: 10.1016/j.bja.2019.08.014. Epub 2019 Sep 25.
- Background: PubMed 32014880El-Kefraoui C, Olleik G, Chay MA, Kouyoumdjian A, Nguyen-Powanda P, Rajabiyazdi F, Do U, Derksen A, Landry T, Amar-Zifkin A, Ramanakumar AV, Martel MO, Baldini G, Feldman L, Fiore JF Jr. Opioid versus opioid-free analgesia after surgical discharge: protocol for a systematic review and meta-analysis. BMJ Open. 2020 Feb 2;10(1):e035443. doi: 10.1136/bmjopen-2019-035443.
- Background: PubMed 32530891Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.
- Background: PubMed 28973092Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132.
- 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.
Henry Ford Medical Center - Grosse Pointe Cottage
Grosse Pointe Farms, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Periarticular Injection, Adductor Canal Block and Bupivacaine-Meloxicam in people with Osteoarthritis (OA) of the Knee, run by Henry Ford Health System 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 1 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score Assessed Using the Numeric Rating Scale (NRS) (time frame: Postoperative Day 0-Postoperative Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07775248, which also lists 10 linked publications.
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 20 Aug 2026.