InfectionPhase 4StimulanNCT03976466
Prophylaxis of Periprosthetic Joint Infections With Calcium Sulfate Beads in Patients With Non-modifiable Risk Factors.
A Phase 4 study testing Antibiotic local prophylaxis with medicated calcium sulfate beads and Classical parenteral antibiotic prophylaxis in people with Infection, run by Hospital Regional Tlalnepantla at 1 site in Mexico.
Trial summary
To demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in patients with non-modifiable risk factors that will undergo a hip or knee joint replacement, comparing with a control group. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Antibiotic local prophylaxis with medicated calcium sulfate beads and Classical parenteral antibiotic prophylaxis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteMexico
- Study dates
- 22 May 2019to 15 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with fracture or osteoarthrosis of the hip or knee that require treatment by joint replacement.
- patients who have any of the Non-Modifiable Risk Factors prior to surgery or during transoperative period.
- Patients entitled to the ISSEMyM (Instituto de Seguridad Social del Estado de Mexico y Municipios)
Who cannot join
- Patients that lose their validity of institutional rights and do not follow up
- Patients who die during the study due to other causes not related to the orthopedic procedure.
- Patients who do not have any of the risk factors for periprosthetic infection
- Patients allergic to vancomycin or ceftriaxone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Antibiotic Loaded Calcium Sulfate as Prophylaxis for Patients With Non Modifiable Risk Factors for Periprosthetic Joint Infections
To demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in patients with non-modifiable risk factors that will undergo a hip or knee joint replacement, comparing with a control group.
To know the economic cost generated in antibiotic prophylaxis with calcium sulfate beads in patients undergoing hip or knee joint replacement with non-modifiable risk factors.
Read the detailed description
Since joint replacement procedures have been successful in recent decades, every year the number of implanted prostheses is increasing, however, at the same time, orthopaedic surgeons also find complications inherent to this surgery, where peri-prosthetic infection results to be the most devastating. In order to find a solution to this terrible complication, prophylactic and therapeutic measures have been implemented, emerging techniques where the application of local antibiotics in the surgical site has turned out to be a promising concept. It has been shown that the non-modifiable risk factors of patients undergoing joint replacement surgery increase the risk of infection rate. Therefore, the identification of risk factors, decolonization and the prophylactic administration of antibiotics allow an effective reduction of periprosthetic infection. In order to reduce and, as far as posible, avoid periprosthetic infections in participants undergo knee or hip joint replacement with non-modifiable risk factors, the prophylactic use of calcium sulphate loaded with antibiotic for local application is proposed.
- Conditions
- Infection
- Being tested
- Antibiotic local prophylaxis with medicated calcium sulfate beads, Classical parenteral antibiotic prophylaxis
- Keywords
- Periprosthetic Joint Infection, Prophylaxis, Joint Replacement, Calcium Sulfate Beads
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic local prophylaxis with medicated calcium sulfate beadsDevice
Also called Hip or Knee Joint Replacement
Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
Classical parenteral antibiotic prophylaxisProcedure or surgery
Also called Hip pr Knee Joint Replacement
Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
| Study group | Role | What they receive |
|---|---|---|
| Calcium sulfate Group | Experimental | Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement Receives: Device: Antibiotic local prophylaxis with medicated calcium sulfate beads |
| Control Group | Active comparator | Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement Receives: Procedure: Classical parenteral antibiotic prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partipants Achieving a Lower Hip or Knee Periprosthetic Joint Infection Rate With Local Versus Conventional Intravenous Antibiotic Prophilaxys, Measured With CRP, ERS in Serum and Sinovial Fluid Leukocytes , Over the 12-week Observation Period.
Acute periprosthetic knee or hip infection was determined using CRP and ESR serum biomarkers, which are the most commonly published serum biomarkers in periprosthetic joint infection literature. The cut off point for CRP was considered 93mg/L and 44mm/hr for ESR. The serum biomarker sample was taken and evaluated on day 5 and weeks 4, 8 and 12. Leukocytes in synovial fluid are among the criteria for definition of periprosthetic joint infection with a cut off point above 12,800 cells/µL and were only included if serum biomarkers were elevated.
Measured: Day 5, Weeks 4, 8, and 12
Secondary outcomes (1)
Length of Stay as an Indicator of the Hospital Economic Burden
The length of stay is an important indicator of efficiency and hospital economic burden. The reduction in number of hospitalization days results in lower risk of infection and less medication side effects and decreased need of hospital supplies. The difference in the average days of hospitalization between both groups indirectly represents the economic cost spent by the hospital.
Measured: Surgical procedure day to hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start22 May 2019
- Primary completion22 Apr 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial. Study participants are randomly assigned to one of two groups: the experimental group receiving the Calcium sulfate beds with antibiotics and a comparison group (control) which receives a conventional prophylactic therapy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Regional Tlalnepantla
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Julio Carlos Velez de Lachica, Hospital Regional Tlalnepantla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976466
- Sponsor's protocol ID
- 01
- Acronym
- Stimulan
- Status last verified
- Aug 2020
- First submitted
- 29 May 2019
- Last updated
- 20 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ong KL, Kurtz SM, Lau E, Bozic KJ, Berry DJ, Parvizi J. Prosthetic joint infection risk after total hip arthroplasty in the Medicare population. J Arthroplasty. 2009 Sep;24(6 Suppl):105-9. doi: 10.1016/j.arth.2009.04.027. Epub 2009 Jun 2.
PubMed 19493644Pulido L, Ghanem E, Joshi A, Purtill JJ, Parvizi J. Periprosthetic joint infection: the incidence, timing, and predisposing factors. Clin Orthop Relat Res. 2008 Jul;466(7):1710-5. doi: 10.1007/s11999-008-0209-4. Epub 2008 Apr 18.
PubMed 18421542Wahl P, Guidi M, Benninger E, Ronn K, Gautier E, Buclin T, Magnin JL, Livio F. The levels of vancomycin in the blood and the wound after the local treatment of bone and soft-tissue infection with antibiotic-loaded calcium sulphate as carrier material. Bone Joint J. 2017 Nov;99-B(11):1537-1544. doi: 10.1302/0301-620X.99B11.BJJ-2016-0298.R3.
PubMed 29092996Wahl P, Livio F, Jacobi M, Gautier E, Buclin T. Systemic exposure to tobramycin after local antibiotic treatment with calcium sulphate as carrier material. Arch Orthop Trauma Surg. 2011 May;131(5):657-62. doi: 10.1007/s00402-010-1192-2. Epub 2010 Oct 12.
PubMed 20938669Reed EE, Johnston J, Severing J, Stevenson KB, Deutscher M. Nephrotoxicity Risk Factors and Intravenous Vancomycin Dosing in the Immediate Postoperative Period Following Antibiotic-Impregnated Cement Spacer Placement. Ann Pharmacother. 2014 Aug;48(8):962-969. doi: 10.1177/1060028014535360. Epub 2014 May 13.
PubMed 24823910Horii C, Yamazaki T, Oka H, Azuma S, Ogihara S, Okazaki R, Kawamura N, Takano Y, Morii J, Takeshita Y, Maruyama T, Yamakawa K, Murakami M, Oshima Y, Tanaka S. Does intrawound vancomycin powder reduce surgical site infection after posterior instrumented spinal surgery? A propensity score-matched analysis. Spine J. 2018 Dec;18(12):2205-2212. doi: 10.1016/j.spinee.2018.04.015. Epub 2018 Apr 26.
PubMed 29705336Sweet FA, Roh M, Sliva C. Intrawound application of vancomycin for prophylaxis in instrumented thoracolumbar fusions: efficacy, drug levels, and patient outcomes. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2084-8. doi: 10.1097/BRS.0b013e3181ff2cb1.
PubMed 21304438Zebala LP, Chuntarapas T, Kelly MP, Talcott M, Greco S, Riew KD. Intrawound vancomycin powder eradicates surgical wound contamination: an in vivo rabbit study. J Bone Joint Surg Am. 2014 Jan 1;96(1):46-51. doi: 10.2106/JBJS.L.01257.
PubMed 24382724Whiteside LA, Peppers M, Nayfeh TA, Roy ME. Methicillin-resistant Staphylococcus aureus in TKA treated with revision and direct intra-articular antibiotic infusion. Clin Orthop Relat Res. 2011 Jan;469(1):26-33. doi: 10.1007/s11999-010-1313-9.
PubMed 20390472Buchholz HW, Engelbrecht H. [Depot effects of various antibiotics mixed with Palacos resins]. Chirurg. 1970 Nov;41(11):511-5. No abstract available. German.
PubMed 5487941Bennett-Guerrero E, Pappas TN, Koltun WA, Fleshman JW, Lin M, Garg J, Mark DB, Marcet JE, Remzi FH, George VV, Newland K, Corey GR; SWIPE 2 Trial Group. Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. N Engl J Med. 2010 Sep 9;363(11):1038-49. doi: 10.1056/NEJMoa1000837. Epub 2010 Aug 4.
PubMed 20825316Birgand G, Radu C, Alkhoder S, Al Attar N, Raffoul R, Dilly MP, Nataf P, Lucet JC. Does a gentamicin-impregnated collagen sponge reduce sternal wound infections in high-risk cardiac surgery patients? Interact Cardiovasc Thorac Surg. 2013 Feb;16(2):134-41. doi: 10.1093/icvts/ivs449. Epub 2012 Oct 31.
PubMed 23115102KOVACEVIC B. [Problem of hematogenous osteomyelitis]. Langenbecks Arch Klin Chir Ver Dtsch Z Chir. 1953;276:432-43. No abstract available. Undetermined Language.
PubMed 13143827Fischer G, Seidler W. [Results in the treatment of osteomyelitic bone cavities using antibiotic gypsum medullary plombage]. Dtsch Gesundheitsw. 1971 Nov 4;26(45):2105-7. No abstract available. German.
PubMed 5145654Mackey D, Varlet A, Debeaumont D. Antibiotic loaded plaster of Paris pellets: an in vitro study of a possible method of local antibiotic therapy in bone infection. Clin Orthop Relat Res. 1982 Jul;(167):263-8.
PubMed 7094471
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Antibiotic Loaded Calcium Sulfate as Prophylaxis for Patients With Non Modifiable Risk Factors for Periprosthetic Joint Infections
- ClinicalTrials.gov ID
- NCT03976466
- Acronym / sponsor ID
- Stimulan / 01
- Conditions
- Infection
- Keywords
- Periprosthetic Joint Infection, Prophylaxis, Joint Replacement, Calcium Sulfate Beads
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Hospital Regional TlalnepantlaOther government
- Study start
- 22 May 2019 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in patients with non-modifiable risk factors that will undergo a hip or knee joint replacement, comparing with a control group.
To know the economic cost generated in antibiotic prophylaxis with calcium sulfate beads in patients undergoing hip or knee joint replacement with non-modifiable risk factors.
Detailed description
Since joint replacement procedures have been successful in recent decades, every year the number of implanted prostheses is increasing, however, at the same time, orthopaedic surgeons also find complications inherent to this surgery, where peri-prosthetic infection results to be the most devastating. In order to find a solution to this terrible complication, prophylactic and therapeutic measures have been implemented, emerging techniques where the application of local antibiotics in the surgical site has turned out to be a promising concept. It has been shown that the non-modifiable risk factors of patients undergoing joint replacement surgery increase the risk of infection rate. Therefore, the identification of risk factors, decolonization and the prophylactic administration of antibiotics allow an effective reduction of periprosthetic infection. In order to reduce and, as far as posible, avoid periprosthetic infections in participants undergo knee or hip joint replacement with non-modifiable risk factors, the prophylactic use of calcium sulphate loaded with antibiotic for local application is proposed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised controlled trial. Study participants are randomly assigned to one of two groups: the experimental group receiving the Calcium sulfate beds with antibiotics and a comparison group (control) which receives a conventional prophylactic therapy.
| Arm | Type | Receives |
|---|---|---|
| Calcium sulfate Group | Experimental | Device: Antibiotic local prophylaxis with medicated calcium sulfate beadsGroup of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement |
| Control Group | Active comparator | Procedure: Classical parenteral antibiotic prophylaxisGroup of members that will be submitted to classic prophylaxis for hip or knee joint replacement |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with fracture or osteoarthrosis of the hip or knee that require treatment by joint replacement.
- patients who have any of the Non-Modifiable Risk Factors prior to surgery or during transoperative period.
- Patients entitled to the ISSEMyM (Instituto de Seguridad Social del Estado de Mexico y Municipios)
Key exclusion criteria (4 listed)
- Patients that lose their validity of institutional rights and do not follow up
- Patients who die during the study due to other causes not related to the orthopedic procedure.
- Patients who do not have any of the risk factors for periprosthetic infection
- Patients allergic to vancomycin or ceftriaxone.
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 |
|---|---|---|
| Antibiotic local prophylaxis with medicated calcium sulfate beadsAlso: Hip or Knee Joint ReplacementAntibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection | Device | Calcium sulfate Group |
| Classical parenteral antibiotic prophylaxisAlso: Hip pr Knee Joint ReplacementAntibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection | Procedure or surgery | Control Group |
Primary outcome
Partipants Achieving a Lower Hip or Knee Periprosthetic Joint Infection Rate With Local Versus Conventional Intravenous Antibiotic Prophilaxys, Measured With CRP, ERS in Serum and Sinovial Fluid Leukocytes , Over the 12-week Observation Period.
Time frame: Day 5, Weeks 4, 8, and 12
Acute periprosthetic knee or hip infection was determined using CRP and ESR serum biomarkers, which are the most commonly published serum biomarkers in periprosthetic joint infection literature. The cut off point for CRP was considered 93mg/L and 44mm/hr for ESR. The serum biomarker sample was taken and evaluated on day 5 and weeks 4, 8 and 12. Leukocytes in synovial fluid are among the criteria for definition of periprosthetic joint infection with a cut off point above 12,800 cells/µL and were only included if serum biomarkers were elevated.
1 secondary outcome
Length of Stay as an Indicator of the Hospital Economic Burden
Time frame: Surgical procedure day to hospital discharge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19493644Ong KL, Kurtz SM, Lau E, Bozic KJ, Berry DJ, Parvizi J. Prosthetic joint infection risk after total hip arthroplasty in the Medicare population. J Arthroplasty. 2009 Sep;24(6 Suppl):105-9. doi: 10.1016/j.arth.2009.04.027. Epub 2009 Jun 2.
- Background: PubMed 18421542Pulido L, Ghanem E, Joshi A, Purtill JJ, Parvizi J. Periprosthetic joint infection: the incidence, timing, and predisposing factors. Clin Orthop Relat Res. 2008 Jul;466(7):1710-5. doi: 10.1007/s11999-008-0209-4. Epub 2008 Apr 18.
- Background: PubMed 29092996Wahl P, Guidi M, Benninger E, Ronn K, Gautier E, Buclin T, Magnin JL, Livio F. The levels of vancomycin in the blood and the wound after the local treatment of bone and soft-tissue infection with antibiotic-loaded calcium sulphate as carrier material. Bone Joint J. 2017 Nov;99-B(11):1537-1544. doi: 10.1302/0301-620X.99B11.BJJ-2016-0298.R3.
- Background: PubMed 20938669Wahl P, Livio F, Jacobi M, Gautier E, Buclin T. Systemic exposure to tobramycin after local antibiotic treatment with calcium sulphate as carrier material. Arch Orthop Trauma Surg. 2011 May;131(5):657-62. doi: 10.1007/s00402-010-1192-2. Epub 2010 Oct 12.
- Background: PubMed 24823910Reed EE, Johnston J, Severing J, Stevenson KB, Deutscher M. Nephrotoxicity Risk Factors and Intravenous Vancomycin Dosing in the Immediate Postoperative Period Following Antibiotic-Impregnated Cement Spacer Placement. Ann Pharmacother. 2014 Aug;48(8):962-969. doi: 10.1177/1060028014535360. Epub 2014 May 13.
- Background: PubMed 29705336Horii C, Yamazaki T, Oka H, Azuma S, Ogihara S, Okazaki R, Kawamura N, Takano Y, Morii J, Takeshita Y, Maruyama T, Yamakawa K, Murakami M, Oshima Y, Tanaka S. Does intrawound vancomycin powder reduce surgical site infection after posterior instrumented spinal surgery? A propensity score-matched analysis. Spine J. 2018 Dec;18(12):2205-2212. doi: 10.1016/j.spinee.2018.04.015. Epub 2018 Apr 26.
- Background: PubMed 21304438Sweet FA, Roh M, Sliva C. Intrawound application of vancomycin for prophylaxis in instrumented thoracolumbar fusions: efficacy, drug levels, and patient outcomes. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2084-8. doi: 10.1097/BRS.0b013e3181ff2cb1.
- Background: PubMed 24382724Zebala LP, Chuntarapas T, Kelly MP, Talcott M, Greco S, Riew KD. Intrawound vancomycin powder eradicates surgical wound contamination: an in vivo rabbit study. J Bone Joint Surg Am. 2014 Jan 1;96(1):46-51. doi: 10.2106/JBJS.L.01257.
- Background: PubMed 20390472Whiteside LA, Peppers M, Nayfeh TA, Roy ME. Methicillin-resistant Staphylococcus aureus in TKA treated with revision and direct intra-articular antibiotic infusion. Clin Orthop Relat Res. 2011 Jan;469(1):26-33. doi: 10.1007/s11999-010-1313-9.
- Background: PubMed 5487941Buchholz HW, Engelbrecht H. [Depot effects of various antibiotics mixed with Palacos resins]. Chirurg. 1970 Nov;41(11):511-5. No abstract available. German.
- Background: PubMed 20825316Bennett-Guerrero E, Pappas TN, Koltun WA, Fleshman JW, Lin M, Garg J, Mark DB, Marcet JE, Remzi FH, George VV, Newland K, Corey GR; SWIPE 2 Trial Group. Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. N Engl J Med. 2010 Sep 9;363(11):1038-49. doi: 10.1056/NEJMoa1000837. Epub 2010 Aug 4.
- Background: PubMed 23115102Birgand G, Radu C, Alkhoder S, Al Attar N, Raffoul R, Dilly MP, Nataf P, Lucet JC. Does a gentamicin-impregnated collagen sponge reduce sternal wound infections in high-risk cardiac surgery patients? Interact Cardiovasc Thorac Surg. 2013 Feb;16(2):134-41. doi: 10.1093/icvts/ivs449. Epub 2012 Oct 31.
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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?
A Phase 4 study testing Antibiotic local prophylaxis with medicated calcium sulfate beads and Classical parenteral antibiotic prophylaxis in people with Infection, run by Hospital Regional Tlalnepantla at 1 site in Mexico.
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 3 inclusion and 4 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 20 Aug 2020. 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 Mexico. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Partipants Achieving a Lower Hip or Knee Periprosthetic Joint Infection Rate With Local Versus Conventional Intravenous Antibiotic Prophilaxys, Measured With CRP, ERS in Serum and Sinovial Fluid Leukocytes , Over the 12-week Observation Period. (time frame: Day 5, Weeks 4, 8, and 12). 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 NCT03976466, which also lists 64 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 2020.