Periprosthetic Fracture Around Prosthetic Joint ImplantNCT06952738
Investigating Periprosthetic Fracture Cultures in Arthroplasty
An observational study of Periprosthetic Fracture Around Prosthetic Joint Implant, run by University of Chicago at 1 site in United States.
Trial summary
This study aims to improve how doctors diagnose infections in patients with broken bones around joint replacements. Currently, there are no clear guidelines to help determine when an infection is present, making treatment decisions difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Fracture Around Prosthetic Joint Implant
- What is being tested?
- Not applicable- observational study
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Oct 2027
- Phase
- Observational
- 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
Study population: This population would include all consenting patients older than 18 years who present to the University of Chicago Medical Center with periprosthetic hip or knee fractures and will require operative management of the fracture or infection.
Who may be able to join
- Adult patients (>18 years old) with periprosthetic fractures around primary or revision hip or knee arthroplasty
- Patients requiring operative management for these fractures (fixation or revision arthroplasty)
- Patients presenting to the University of Chicago Medical Center during two (2) year period (October 2025 to October 2027)
Who cannot join
- Patients undergoing non-operative management for periprosthetic fractures
- Any documented or reported history of past prosthetic joint infection of the involved joint
- Sinus tract at the time of presentation at the involved joint
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vincent Buckman, BS contact
United States1 site, 1 recruiting
- Recruiting
The University of Chicago Medical Center
Chicago, Illinois, 60637
Sara Wallace, Doctor of Medicine, 773-834-3531, swallace2@bsd.uchicago.edu
About this study
Official title: Investigating Periprosthetic Fracture Culture Positivity in Patients With Hip and Knee Arthroplasties
This study aims to improve how doctors diagnose infections in patients with broken bones around joint replacements. Currently, there are no clear guidelines to help determine when an infection is present, making treatment decisions difficult. By studying how often infections are found through lab tests and identifying factors that predict infection, the investigators hope to create better ways to diagnose and care for these patients.
Read the detailed description
All steps in the protocol will be completed under the standard of care for our hospital's orthopedic joints and trauma surgeons. All patients identified under the inclusion criteria will undergo preoperative imaging. In accordance with current standards of care, patients with periprosthetic fractures (PPFs) around the hip will receive three views of X-rays of the hip and femur as well as the anterior-posterior view of the pelvis. Likewise, patients with PPFs around the knee will undergo X-rays that include the knee and femur. No advanced imaging (Computed Tomography, Magnetic Resonance Imaging, etc.) will be obtained for the purpose of this study.
Preoperative laboratory analysis will include C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) as inflammatory markers. Intraoperative synovial fluid analysis will be performed using synovial white blood cell (WBC) count and polymorphonuclear (PMN) percentage. Three cultures will be obtained from the involved joint fluid and tissue, and incubated for 14 days for analysis of aerobic, anaerobic bacterial cultures, fungal and acid-fast bacilli (AFB) analysis. The cultures will be collected from synovial fluid, peri-implant femoral synovium/periosteum, peri-implant tibial or acetabular synovium/periosteum. These laboratory tests and cultures are part of the standard protocol our surgeons have determined for their patient care.
Based on the Musculoskeletal Infection Society (MSIS) criteria for positive histology intraoperative histology will be performed utilizing frozen section analysis. These slides will be isolated from synovium, peri-implant femoral synovium/periosteum, and peri-implant tibial or acetabular synovium/periosteum. Additional cultures may be sent at discretion of surgeon but would not be included in analysis.
Per institutional protocol, preoperative cefazolin and vancomycin will be administered intravenously and continued for 24 hours perioperatively. Patients who are allergic to vancomycin will receive daptomycin, and those who are allergic to beta-lactam drugs including cephalosporins will be given gentamicin. No intra-articular antibiotics will be routinely administered.
All cultures will be followed until final. If cultures become positive, our institutional infectious disease (ID) department will be consulted for further recommendations and consideration for treatment.
- Being tested
- Not applicable- observational study
- Keywords
- Periprosthetic fractures, synovial fluid, prosthetic joint infections
- Medical subject headings
- Periprosthetic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
The investigators are only looking to see the rate of positivity of the cultures as well as what the organisms that are found in the cultures are.
| Study group | Role | What they receive |
|---|---|---|
| Periprosthetic Fractures | This group will be all patients enrolled in the study: they will all have periprosthetic hip or knee fractures. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture Positivity Rates
This outcome measure is the percentage of cultures that grow organisms among the population
Measured: From enrollment to the end of treatment at 14 days.
Secondary outcomes (3)
Rate of Complications
Number of participants with surgery-related complications within one year after their surgeries.
Measured: From date of surgery to one year after the specific participant's surgery.
Culture Organisms
The names, number, and frequency of organisms being found in the cultures.
Measured: From surgery date to 14 days after surgery.
Treatments Used
The list of antibiotics used for treating organisms found to be positive in the cultures.
Measured: From enrollment to one year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Oct 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic Fracture Around Prosthetic Joint ImplantStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Wallace, MD, Principal investigator, The University of Chicago Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952738
- Sponsor's protocol ID
- IRB25-0498
- Status last verified
- Dec 2025
- First submitted
- 23 Apr 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parvizi J, Tan TL, Goswami K, Higuera C, Della Valle C, Chen AF, Shohat N. The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria. J Arthroplasty. 2018 May;33(5):1309-1314.e2. doi: 10.1016/j.arth.2018.02.078. Epub 2018 Feb 26.
PubMed 29551303McArthur BA, Abdel MP, Taunton MJ, Osmon DR, Hanssen AD. Seronegative infections in hip and knee arthroplasty: periprosthetic infections with normal erythrocyte sedimentation rate and C-reactive protein level. Bone Joint J. 2015 Jul;97-B(7):939-44. doi: 10.1302/0301-620X.97B7.35500.
PubMed 26130349Schinsky MF, Della Valle CJ, Sporer SM, Paprosky WG. Perioperative testing for joint infection in patients undergoing revision total hip arthroplasty. J Bone Joint Surg Am. 2008 Sep;90(9):1869-75. doi: 10.2106/JBJS.G.01255.
PubMed 18762646Shah RP, Plummer DR, Moric M, Sporer SM, Levine BR, Della Valle CJ. Diagnosing Infection in the Setting of Periprosthetic Fractures. J Arthroplasty. 2016 Sep;31(9 Suppl):140-3. doi: 10.1016/j.arth.2015.08.045. Epub 2016 Mar 17.
PubMed 27067465Preston S, Somerville L, Lanting B, Howard J. Are Nucleated Cell Counts Useful in the Diagnosis of Infection in Periprosthetic Fracture? Clin Orthop Relat Res. 2015 Jul;473(7):2238-43. doi: 10.1007/s11999-015-4162-8.
PubMed 25631172Chevillotte CJ, Ali MH, Trousdale RT, Larson DR, Gullerud RE, Berry DJ. Inflammatory laboratory markers in periprosthetic hip fractures. J Arthroplasty. 2009 Aug;24(5):722-7. doi: 10.1016/j.arth.2008.05.026. Epub 2008 Sep 11.
PubMed 18789633Austin MS, Ghanem E, Joshi A, Lindsay A, Parvizi J. A simple, cost-effective screening protocol to rule out periprosthetic infection. J Arthroplasty. 2008 Jan;23(1):65-8. doi: 10.1016/j.arth.2007.09.005.
PubMed 18165031van den Kieboom J, Tirumala V, Xiong L, Klemt C, Kwon YM. Concomitant Hip and Knee Periprosthetic Joint Infection in Periprosthetic Fracture: Diagnostic Utility of Serum and Synovial Fluid Markers. J Arthroplasty. 2021 Feb;36(2):722-727. doi: 10.1016/j.arth.2020.08.029. Epub 2020 Aug 18.
PubMed 32893059Barberis L, Abdelrahman T, Driscoll DA, Dasci MF, Gehrke T, Citak M. Unexpected Positive Cultures in Hip and Knee Periprosthetic Fractures. J Arthroplasty. 2024 Jul;39(7):1834-1839. doi: 10.1016/j.arth.2024.01.030. Epub 2024 Jan 18.
PubMed 38244640Shichman I, Roof M, Askew N, Nherera L, Rozell JC, Seyler TM, Schwarzkopf R. Projections and Epidemiology of Primary Hip and Knee Arthroplasty in Medicare Patients to 2040-2060. JB JS Open Access. 2023 Feb 28;8(1):e22.00112. doi: 10.2106/JBJS.OA.22.00112. eCollection 2023 Jan-Mar.
PubMed 36864906Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.
PubMed 30180053
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Periprosthetic Fracture Culture Positivity in Patients With Hip and Knee Arthroplasties
- ClinicalTrials.gov ID
- NCT06952738
- Acronym / sponsor ID
- IRB25-0498
- Keywords
- Periprosthetic fractures, synovial fluid, prosthetic joint infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 1 May 2025 (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 aims to improve how doctors diagnose infections in patients with broken bones around joint replacements. Currently, there are no clear guidelines to help determine when an infection is present, making treatment decisions difficult. By studying how often infections are found through lab tests and identifying factors that predict infection, the investigators hope to create better ways to diagnose and care for these patients.
Detailed description
All steps in the protocol will be completed under the standard of care for our hospital's orthopedic joints and trauma surgeons. All patients identified under the inclusion criteria will undergo preoperative imaging. In accordance with current standards of care, patients with periprosthetic fractures (PPFs) around the hip will receive three views of X-rays of the hip and femur as well as the anterior-posterior view of the pelvis. Likewise, patients with PPFs around the knee will undergo X-rays that include the knee and femur. No advanced imaging (Computed Tomography, Magnetic Resonance Imaging, etc.) will be obtained for the purpose of this study.
Preoperative laboratory analysis will include C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) as inflammatory markers. Intraoperative synovial fluid analysis will be performed using synovial white blood cell (WBC) count and polymorphonuclear (PMN) percentage. Three cultures will be obtained from the involved joint fluid and tissue, and incubated for 14 days for analysis of aerobic, anaerobic bacterial cultures, fungal and acid-fast bacilli (AFB) analysis. The cultures will be collected from synovial fluid, peri-implant femoral synovium/periosteum, peri-implant tibial or acetabular synovium/periosteum. These laboratory tests and cultures are part of the standard protocol our surgeons have determined for their patient care.
Based on the Musculoskeletal Infection Society (MSIS) criteria for positive histology intraoperative histology will be performed utilizing frozen section analysis. These slides will be isolated from synovium, peri-implant femoral synovium/periosteum, and peri-implant tibial or acetabular synovium/periosteum. Additional cultures may be sent at discretion of surgeon but would not be included in analysis.
Per institutional protocol, preoperative cefazolin and vancomycin will be administered intravenously and continued for 24 hours perioperatively. Patients who are allergic to vancomycin will receive daptomycin, and those who are allergic to beta-lactam drugs including cephalosporins will be given gentamicin. No intra-articular antibiotics will be routinely administered.
All cultures will be followed until final. If cultures become positive, our institutional infectious disease (ID) department will be consulted for further recommendations and consideration for treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periprosthetic Fractures | – | Other: Not applicable- observational studyThis group will be all patients enrolled in the study: they will all have periprosthetic hip or knee fractures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This population would include all consenting patients older than 18 years who present to the University of Chicago Medical Center with periprosthetic hip or knee fractures and will require operative management of the fracture or infection.
Key inclusion criteria (3 listed)
- Adult patients (>18 years old) with periprosthetic fractures around primary or revision hip or knee arthroplasty
- Patients requiring operative management for these fractures (fixation or revision arthroplasty)
- Patients presenting to the University of Chicago Medical Center during two (2) year period (October 2025 to October 2027)
Key exclusion criteria (3 listed)
- Patients undergoing non-operative management for periprosthetic fractures
- Any documented or reported history of past prosthetic joint infection of the involved joint
- Sinus tract at the time of presentation at the involved joint
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 |
|---|---|---|
| Not applicable- observational studyThe investigators are only looking to see the rate of positivity of the cultures as well as what the organisms that are found in the cultures are. | Other | Periprosthetic Fractures |
Primary outcome
Culture Positivity Rates
Time frame: From enrollment to the end of treatment at 14 days.
This outcome measure is the percentage of cultures that grow organisms among the population
3 secondary outcomes
Rate of Complications
Time frame: From date of surgery to one year after the specific participant's surgery.
Culture Organisms
Time frame: From surgery date to 14 days after surgery.
Treatments Used
Time frame: From enrollment to one year after surgery.
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 22 Dec 2025.
- Background: PubMed 29551303Parvizi J, Tan TL, Goswami K, Higuera C, Della Valle C, Chen AF, Shohat N. The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria. J Arthroplasty. 2018 May;33(5):1309-1314.e2. doi: 10.1016/j.arth.2018.02.078. Epub 2018 Feb 26.
- Background: PubMed 26130349McArthur BA, Abdel MP, Taunton MJ, Osmon DR, Hanssen AD. Seronegative infections in hip and knee arthroplasty: periprosthetic infections with normal erythrocyte sedimentation rate and C-reactive protein level. Bone Joint J. 2015 Jul;97-B(7):939-44. doi: 10.1302/0301-620X.97B7.35500.
- Background: PubMed 18762646Schinsky MF, Della Valle CJ, Sporer SM, Paprosky WG. Perioperative testing for joint infection in patients undergoing revision total hip arthroplasty. J Bone Joint Surg Am. 2008 Sep;90(9):1869-75. doi: 10.2106/JBJS.G.01255.
- Background: PubMed 27067465Shah RP, Plummer DR, Moric M, Sporer SM, Levine BR, Della Valle CJ. Diagnosing Infection in the Setting of Periprosthetic Fractures. J Arthroplasty. 2016 Sep;31(9 Suppl):140-3. doi: 10.1016/j.arth.2015.08.045. Epub 2016 Mar 17.
- Background: PubMed 25631172Preston S, Somerville L, Lanting B, Howard J. Are Nucleated Cell Counts Useful in the Diagnosis of Infection in Periprosthetic Fracture? Clin Orthop Relat Res. 2015 Jul;473(7):2238-43. doi: 10.1007/s11999-015-4162-8.
- Background: PubMed 18789633Chevillotte CJ, Ali MH, Trousdale RT, Larson DR, Gullerud RE, Berry DJ. Inflammatory laboratory markers in periprosthetic hip fractures. J Arthroplasty. 2009 Aug;24(5):722-7. doi: 10.1016/j.arth.2008.05.026. Epub 2008 Sep 11.
- Background: PubMed 18165031Austin MS, Ghanem E, Joshi A, Lindsay A, Parvizi J. A simple, cost-effective screening protocol to rule out periprosthetic infection. J Arthroplasty. 2008 Jan;23(1):65-8. doi: 10.1016/j.arth.2007.09.005.
- Background: PubMed 32893059van den Kieboom J, Tirumala V, Xiong L, Klemt C, Kwon YM. Concomitant Hip and Knee Periprosthetic Joint Infection in Periprosthetic Fracture: Diagnostic Utility of Serum and Synovial Fluid Markers. J Arthroplasty. 2021 Feb;36(2):722-727. doi: 10.1016/j.arth.2020.08.029. Epub 2020 Aug 18.
- Background: PubMed 38244640Barberis L, Abdelrahman T, Driscoll DA, Dasci MF, Gehrke T, Citak M. Unexpected Positive Cultures in Hip and Knee Periprosthetic Fractures. J Arthroplasty. 2024 Jul;39(7):1834-1839. doi: 10.1016/j.arth.2024.01.030. Epub 2024 Jan 18.
- Background: PubMed 36864906Shichman I, Roof M, Askew N, Nherera L, Rozell JC, Seyler TM, Schwarzkopf R. Projections and Epidemiology of Primary Hip and Knee Arthroplasty in Medicare Patients to 2040-2060. JB JS Open Access. 2023 Feb 28;8(1):e22.00112. doi: 10.2106/JBJS.OA.22.00112. eCollection 2023 Jan-Mar.
- Background: PubMed 30180053Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.
- Individual participant dataSharing planned: No
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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.
Vincent Buckman, BS contact
Sara Wallace, MD principal investigator
The University of Chicago Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periprosthetic Fracture Around Prosthetic Joint Implant, run by University of Chicago 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 3 inclusion and 3 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 22 Dec 2025. 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.
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 Malik J Scott, BA (773-834-0822, mjscott1@uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Culture Positivity Rates (time frame: From enrollment to the end of treatment at 14 days.). 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 NCT06952738, which also lists 11 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 22 Dec 2025.