Total Knee AnthroplastyPhase 4NCT07878507
Smart Knee Evaluation of Exparel and Zynrelef in TKA Recovery
A Phase 4 study testing Intra-articular injection of bupivacaine in the knee joint, intra-articular injection of Exparel in the knee joint and Zynrelef in people with Total Knee Anthroplasty, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
Trial summary
This study looks at how three different numbing injections affect how quickly patients recover after knee replacement surgery (total knee arthroplasty, or TKA). Pain after knee replacement is common and can slow down how soon patients get moving again. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Total Knee Anthroplasty
- What is being tested?
- Intra-articular injection of bupivacaine in the knee joint, intra-articular injection of Exparel in the knee joint and Zynrelef
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 25 Apr 2028
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo primary unilateral total knee arthroplasty for symptomatic end-stage osteoarthritis, with the Persona IQ implant.
- Timed Up and Go (TUG) Test <20 seconds
- Planned to receive a periarticular injection of either liposomal bupivacaine, bupivacaine mixed with meloxicam, or bupivacaine hydrochloride alone as part of surgical care.
- Willing and able to provide written informed consent and to complete the first-week assessment schedule.
Who cannot join
- Revision or unicompartmental-only knee replacement.
- Diabetes with A1c >7.5
- Morbid obesity with BMI >40 kg/m2
- Chronic opioid use
- PJI/Infection
- Documented allergy or intolerance to amide-type local anesthetics.
Show all 9Show fewer
- Severe inflammatory arthropathy (e.g., rheumatoid arthritis) with more than 4 joints affected.
- Objective evidence of nerve damage in the affected limb, or another condition precluding the assessments or the intervention.
- Inability to provide informed consent or to complete the first-week assessments; or concurrent enrollment in another interventional drug trial.
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
Florida Orthopaedic Institute
Tampa, Florida, 33607
8139789700
About this study
Official title: Use of Smart Knee Implant to Evaluate Efficacy and Superiority of Liposomal Bupivacaine and Bupivacaine With Meloxicam in Early TKA Recovery
This study looks at how three different numbing injections affect how quickly patients recover after knee replacement surgery (total knee arthroplasty, or TKA). Pain after knee replacement is common and can slow down how soon patients get moving again. Doctors often inject a numbing medication around the knee during surgery to help control this pain, but it is not clear which medication helps patients recover fastest in the first few days after surgery.
The study compares three injections that are all FDA approved and already used as part of routine knee replacement care: Exparel (liposomal bupivacaine), Zynrelef (bupivacaine with meloxicam), and Marcaine (bupivacaine). Exparel and Zynrelef are the two groups being studied, and Marcaine is the comparison (control) group.
Read more
Adults who are already planning to have a knee replacement may take part. People who join are placed into one of the three injection groups at random, so each person has a one in three chance of receiving each injection. Patients are not told which injection they received. Everything else about the surgery, anesthesia, and recovery care stays the same as usual.
The main goal is to see which injection helps patients recover best in the first three days after surgery. To measure recovery, the study team collects information on pain, pain-medication use, knee motion, activity level, and function. Patients complete short questionnaires about their activity, pain, and quality of life at their regular visits (before surgery and at 3 days, 1 week, 2 weeks, 6 weeks, 3 months, 1 year, and 2 years). A smart knee implant also records information about knee movement and motion at 3 and 7 days after surgery. About 200 people will take part. The study is considered minimal risk, meaning the risks are similar to those of having a knee replacement outside of the study.
- Conditions
- Total Knee Anthroplasty
- Being tested
- Intra-articular injection of bupivacaine in the knee joint, intra-articular injection of Exparel in the knee joint, Zynrelef
- Keywords
- Total Knee Arthroplasty, Intra-articular Injection, Early Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular injection of bupivacaine in the knee jointDrug
The intervention is the use of bupivacaine for the intra-articular injection
intra-articular injection of Exparel in the knee jointDrug
The intervention is the intra-articular injection of Exparel in the knee joint
ZynrelefDrug
The intervention is the use of Zynbrelef for the intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Experimental | These patients will receive Exparel as their Intra-articular injection Receives: Drug: intra-articular injection of Exparel in the knee joint |
| Zynrelef | Experimental | These patients will receive Zynrelef as their Intra-articular injection Receives: Drug: Zynrelef |
| Bupivicaine | Active comparator | These patients will receive Bupivicaine as their Intra-articular injection Receives: Drug: Intra-articular injection of bupivacaine in the knee joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Functional Recovery
To compare the rate of early functional recovery during the first 3 postoperative days, measured as the change/improvement over time in objective gait metrics and daily total qualified step count, between the Exparel group, Zynrelef group, and the bupivacaine hydrochloride alone group.
Measured: First 3 days post-op
Secondary outcomes (12)
ROM
To compare the rate of improvement in knee/functional range of motion (ROM) at 1 week post-operatively and out to 2 years post-operatively
Measured: Up to 2 years post-operatively
Visual Analogue Scale
To compare postoperative pain scores (VAS/numeric). The scale is from 0-10 with higher scores indicating greater pain.
Measured: 2 years post-op
Opioid Consumption
To compare cumulative opioid consumption (oral morphine equivalents)
Measured: 2 years post-op
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
To compare the KOOS Pain subscale is from 0-100 with higher scores meaning worse knee problems
Measured: 2 years post-operatively
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms
To compare the KOOS Symptoms subscale, which is from 0-100 with higher scores meaning worse knee problems
Measured: 2 years post-operatively
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Function
To compare the KOOS Function subscale, which is from 0-100 with higher scores meaning worse knee problems
Measured: 2 years post-operatively
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport & Recreation
To compare the KOOS Sport \& Recreation subscale, which is from 0-100 with higher scores meaning worse knee problems
Measured: 2 years post-operatively
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
To compare the KOOS Quality of Life subscale, which is from 0-100 with higher scores meaning worse knee problems
Measured: 2 years post-operatively
Knee Society Score (KSS)
To compare the KSS score - Scale is from 0-100 with higher scores meaning fewer knee problems
Measured: 2 years post-operatively
UCLA Activity Score
To compare the UCLA Activity Score is from 1-10 with higher scores meaning higher levels of activity
Measured: 2 years post-operatively
Tegner Activity Score
To compare the Tegner Activity Score is from 0-10 with higher scores meaning higher levels of activity
Measured: 2 years post-operatively
5-level EQ-5D version (EQ-5D-5L) Quality of Life Score
To compare the EQ-5D-5L Quality of Life Score is from 1-10 with higher scores meaning higher levels problem severity
Measured: 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion25 Apr 2028 (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 Total Knee AnthroplastyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet, Florida Orthopaedic Institute
- Responsible party
- Sponsor
- Investigators
- Steven Lyons, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878507
- Sponsor's protocol ID
- STUDY010693
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with researchers outside the study team. The study collects identifiable clinical data as part of routine total knee arthroplasty care, and participants consent to its use only for this study. As stated in the informed consent, participant data will not be used or distributed for future research studies, even with identifiers removed. Any future sharing would require a separate protocol and IRB approval, along with participant re-consent where applicable.
Publications
Kuang MJ, Du Y, Ma JX, He W, Fu L, Ma XL. The Efficacy of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Apr;32(4):1395-1402. doi: 10.1016/j.arth.2016.12.025. Epub 2016 Dec 23.
PubMed 28082044Lyman S, Hidaka C, Fields K, Islam W, Mayman D. Monitoring Patient Recovery After THA or TKA Using Mobile Technology. HSS J. 2020 Dec;16(Suppl 2):358-365. doi: 10.1007/s11420-019-09746-3. Epub 2020 Feb 12.
PubMed 33380968Cushner FD, Hunter OF, Lee DC. How Active Are Our Patients in the First 6 Weeks Following Total Knee Arthroplasty? J Arthroplasty. 2024 Aug;39(8 Suppl 1):S125-S129. doi: 10.1016/j.arth.2024.02.071. Epub 2024 Feb 28.
PubMed 38428687Lee 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 35688442Yip T, Hu J, Hawn PS, Yamamoto A, Oderda G. HTX-011 effectively reduces postoperative pain intensity and opioid use in the elderly. Pain Manag. 2022 Jan;12(1):45-57. doi: 10.2217/pmt-2021-0043. Epub 2021 Jul 21.
PubMed 34284613Lachiewicz 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 32561266Yu S, Szulc A, Walton S, Bosco J, Iorio R. Pain Control and Functional Milestones in Total Knee Arthroplasty: Liposomal Bupivacaine versus Femoral Nerve Block. Clin Orthop Relat Res. 2017 Jan;475(1):110-117. doi: 10.1007/s11999-016-4740-4.
PubMed 26883652Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.
PubMed 28802777Hamilton TW, Knight R, Stokes JR, Rombach I, Cooper C, Davies L, Dutton SJ, Barker KL, Cook J, Lamb SE, Murray DW, Poulton L, Wang A, Strickland LH, Van Duren BH, Leal J, Beard D, Pandit HG; Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK) Study Group. Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Periarticular Anesthetic for Patients Undergoing Knee Replacement: A Randomized Clinical Trial. JAMA Surg. 2022 Jun 1;157(6):481-489. doi: 10.1001/jamasurg.2022.0713.
PubMed 35385072Hamilton TW, Athanassoglou V, Mellon S, Strickland LH, Trivella M, Murray D, Pandit HG. Liposomal bupivacaine infiltration at the surgical site for the management of postoperative pain. Cochrane Database Syst Rev. 2017 Feb 1;2(2):CD011419. doi: 10.1002/14651858.CD011419.pub2.
PubMed 28146271
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Smart Knee Implant to Evaluate Efficacy and Superiority of Liposomal Bupivacaine and Bupivacaine With Meloxicam in Early TKA Recovery
- ClinicalTrials.gov ID
- NCT07878507
- Acronym / sponsor ID
- STUDY010693
- Conditions
- Total Knee Anthroplasty
- Keywords
- Total Knee Arthroplasty, Intra-articular Injection, Early Recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Collaborators
- Zimmer Biomet, Florida Orthopaedic Institute
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 25 Apr 2028 (estimated)
- First posted
- 16 Oct 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 study looks at how three different numbing injections affect how quickly patients recover after knee replacement surgery (total knee arthroplasty, or TKA). Pain after knee replacement is common and can slow down how soon patients get moving again. Doctors often inject a numbing medication around the knee during surgery to help control this pain, but it is not clear which medication helps patients recover fastest in the first few days after surgery.
The study compares three injections that are all FDA approved and already used as part of routine knee replacement care: Exparel (liposomal bupivacaine), Zynrelef (bupivacaine with meloxicam), and Marcaine (bupivacaine). Exparel and Zynrelef are the two groups being studied, and Marcaine is the comparison (control) group.
Adults who are already planning to have a knee replacement may take part. People who join are placed into one of the three injection groups at random, so each person has a one in three chance of receiving each injection. Patients are not told which injection they received. Everything else about the surgery, anesthesia, and recovery care stays the same as usual.
The main goal is to see which injection helps patients recover best in the first three days after surgery. To measure recovery, the study team collects information on pain, pain-medication use, knee motion, activity level, and function. Patients complete short questionnaires about their activity, pain, and quality of life at their regular visits (before surgery and at 3 days, 1 week, 2 weeks, 6 weeks, 3 months, 1 year, and 2 years). A smart knee implant also records information about knee movement and motion at 3 and 7 days after surgery. About 200 people will take part. The study is considered minimal risk, meaning the risks are similar to those of having a knee replacement outside of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exparel | Experimental | Drug: intra-articular injection of Exparel in the knee jointThese patients will receive Exparel as their Intra-articular injection |
| Zynrelef | Experimental | Drug: ZynrelefThese patients will receive Zynrelef as their Intra-articular injection |
| Bupivicaine | Active comparator | Drug: Intra-articular injection of bupivacaine in the knee jointThese patients will receive Bupivicaine as their Intra-articular injection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo primary unilateral total knee arthroplasty for symptomatic end-stage osteoarthritis, with the Persona IQ implant.
- Timed Up and Go (TUG) Test <20 seconds
- Planned to receive a periarticular injection of either liposomal bupivacaine, bupivacaine mixed with meloxicam, or bupivacaine hydrochloride alone as part of surgical care.
- Willing and able to provide written informed consent and to complete the first-week assessment schedule.
Key exclusion criteria (9 listed)
- Revision or unicompartmental-only knee replacement.
- Diabetes with A1c >7.5
- Morbid obesity with BMI >40 kg/m2
- Chronic opioid use
- PJI/Infection
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 |
|---|---|---|
| Intra-articular injection of bupivacaine in the knee jointThe intervention is the use of bupivacaine for the intra-articular injection | Drug | Bupivicaine |
| intra-articular injection of Exparel in the knee jointThe intervention is the intra-articular injection of Exparel in the knee joint | Drug | Exparel |
| ZynrelefThe intervention is the use of Zynbrelef for the intra-articular injection | Drug | Zynrelef |
Primary outcome
Early Functional Recovery
Time frame: First 3 days post-op
To compare the rate of early functional recovery during the first 3 postoperative days, measured as the change/improvement over time in objective gait metrics and daily total qualified step count, between the Exparel group, Zynrelef group, and the bupivacaine hydrochloride alone group.
12 secondary outcomes
ROM
Time frame: Up to 2 years post-operatively
Visual Analogue Scale
Time frame: 2 years post-op
Opioid Consumption
Time frame: 2 years post-op
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
Time frame: 2 years post-operatively
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms
Time frame: 2 years post-operatively
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Function
Time frame: 2 years post-operatively
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport & Recreation
Time frame: 2 years post-operatively
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
Time frame: 2 years post-operatively
Knee Society Score (KSS)
Time frame: 2 years post-operatively
UCLA Activity Score
Time frame: 2 years post-operatively
Tegner Activity Score
Time frame: 2 years post-operatively
5-level EQ-5D version (EQ-5D-5L) Quality of Life Score
Time frame: 2 years post-operatively
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 16 Oct 2026.
- Results publication: PubMed 28082044Kuang MJ, Du Y, Ma JX, He W, Fu L, Ma XL. The Efficacy of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Apr;32(4):1395-1402. doi: 10.1016/j.arth.2016.12.025. Epub 2016 Dec 23.
- Results publication: PubMed 33380968Lyman S, Hidaka C, Fields K, Islam W, Mayman D. Monitoring Patient Recovery After THA or TKA Using Mobile Technology. HSS J. 2020 Dec;16(Suppl 2):358-365. doi: 10.1007/s11420-019-09746-3. Epub 2020 Feb 12.
- Results publication: PubMed 38428687Cushner FD, Hunter OF, Lee DC. How Active Are Our Patients in the First 6 Weeks Following Total Knee Arthroplasty? J Arthroplasty. 2024 Aug;39(8 Suppl 1):S125-S129. doi: 10.1016/j.arth.2024.02.071. Epub 2024 Feb 28.
- Results publication: 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.
- Results publication: PubMed 34284613Yip T, Hu J, Hawn PS, Yamamoto A, Oderda G. HTX-011 effectively reduces postoperative pain intensity and opioid use in the elderly. Pain Manag. 2022 Jan;12(1):45-57. doi: 10.2217/pmt-2021-0043. Epub 2021 Jul 21.
- Results publication: 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.
- Results publication: PubMed 26883652Yu S, Szulc A, Walton S, Bosco J, Iorio R. Pain Control and Functional Milestones in Total Knee Arthroplasty: Liposomal Bupivacaine versus Femoral Nerve Block. Clin Orthop Relat Res. 2017 Jan;475(1):110-117. doi: 10.1007/s11999-016-4740-4.
- Results publication: PubMed 28802777Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.
- Results publication: PubMed 35385072Hamilton TW, Knight R, Stokes JR, Rombach I, Cooper C, Davies L, Dutton SJ, Barker KL, Cook J, Lamb SE, Murray DW, Poulton L, Wang A, Strickland LH, Van Duren BH, Leal J, Beard D, Pandit HG; Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK) Study Group. Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Periarticular Anesthetic for Patients Undergoing Knee Replacement: A Randomized Clinical Trial. JAMA Surg. 2022 Jun 1;157(6):481-489. doi: 10.1001/jamasurg.2022.0713.
- Results publication: PubMed 28146271Hamilton TW, Athanassoglou V, Mellon S, Strickland LH, Trivella M, Murray D, Pandit HG. Liposomal bupivacaine infiltration at the surgical site for the management of postoperative pain. Cochrane Database Syst Rev. 2017 Feb 1;2(2):CD011419. doi: 10.1002/14651858.CD011419.pub2.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with researchers outside the study team. The study collects identifiable clinical data as part of routine total knee arthroplasty care, and participants consent to its use only for this study. As stated in the informed consent, participant data will not be used or distributed for future research studies, even with identifiers removed. Any future sharing would require a separate protocol and IRB approval, along with participant re-consent where applicable.
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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.
Steven Lyons, MD principal investigator
Florida Orthopaedic Institute
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 Intra-articular injection of bupivacaine in the knee joint, intra-articular injection of Exparel in the knee joint and Zynrelef in people with Total Knee Anthroplasty, run by Foundation for Orthopaedic Research and Education 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 9 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 16 Oct 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?
Contact Andy Nguyen, BS (8139789700, anguyen@foreonline.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Functional Recovery (time frame: First 3 days post-op). 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 NCT07878507, 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 16 Oct 2026.