Bone Cement Implantation SyndromeBCISNCT06952257
Relationship Between Anesthetic Regimen and Bone Cement Implantation Syndrome (BCIS)
A study testing Administration of general anaesthesia and Neuraxial Analgesia in people with Bone Cement Implantation Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial summary
The annual incidence of geriatric hip fractures in the United States is 325,000 and is projected to rise given the aging population.1 The mainstay of treatment is cemented hip hemiarthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Cement Implantation Syndrome
- What is being tested?
- Administration of general anaesthesia and Neuraxial Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2027to 1 May 2028
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 years old that are indicated for cemented hemiarthroplasty for hip fracture.
Who cannot join
- Patients with medical comorbidities that preclude randomization to an anesthetic regimen (e.g., severe aortic stenosis contraindicating general anesthesia or therapeutic anticoagulation contraindicating neuraxial anesthesia) or
- a severe cognitive impairment that precludes the ability to provide informed consent.
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
Dept of Orthopadic Surgery, Johns Hopkins Hospital, JHOC 5221, 601 N. Caroline St.
Baltimore, Maryland, 21287
About this study
Official title: Pilot Study: Relationship Between Anesthetic Regimen and Bone Cement Implantation Syndrome
The annual incidence of geriatric hip fractures in the United States is 325,000 and is projected to rise given the aging population.1 The mainstay of treatment is cemented hip hemiarthroplasty. Bone cement implantation syndrome (BCIS) is a serious perioperative complication unique to cemented arthroplasty characterized by hypoxia, hypotension, cardiac arrhythmias, and in severe cases, cardiac arrest. BCIS is associated with significantly higher rates of unplanned intubation, vasopressor use, prolonged hospitalization, and 30-day mortality.
Given the rising incidence of hip fractures, the identification of readily modifiable risk factors for BCIS such as anesthetic regimen is crucial to reduce morbidity and mortality. However, a prospective study comparing the rate of BCIS development between general and neuraxial anesthesia is currently lacking. Additionally, no studies have examined how the anesthetic regimen affects histamine and complement levels. Therefore, this pilot study aims to investigate the effect of anesthetic regimen on BCIS development as well as on histamine and complement levels in patients undergoing cemented hemiarthroplasty for hip fracture. The investigators hypothesize that neuraxial anesthesia will be associated with lower rates of BCIS as well as lower histamine and complement levels compared to general anesthesia.
Read more
The primary objective of this pilot study is to compare the effect of general and neuraxial anesthesia on the incidence and severity of BCIS in patients undergoing cemented hemiarthroplasty for hip fracture.
Secondary objectives include examining postoperative outcomes associated with BCIS, such as cardiac arrhythmias, unplanned intubation, hypoxia necessitating supplemental oxygen, altered mental status, and in-hospital mortality.
Additional objectives include comparing histamine and complement levels between anesthetic regimens as well as between patients with and without BCIS
Read the detailed description
This study will be a prospective, randomized pilot study involving adult patients undergoing cemented hemiarthroplasty for hip fracture within the Johns Hopkins healthcare system. In total, 20-24 participants will be randomly assigned to receive either general anesthesia or neuraxial anesthesia with sedation. The use of general or neuraxial anesthesia in this study is consistent with the current standard of care for hip hemiarthroplasty. Randomization will be performed via computer-generated sequences and allocation concealment will be maintained. Blinding patients, anesthesiologists, and orthopedic surgeons to the anesthetic regimen is not possible, but the investigator(s) conducting the statistical analyses will be blinded to the anesthesic regimen.
Patients presenting to the Johns Hopkins system with a hip fracture will be screened for possible participation. If eligible for inclusion, informed consent will be obtained from the patient preoperatively. Patients will subsequently undergo a cemented hip hemiarthroplasty with an orthopedic surgeon under either general or neuraxial anesthesia. Intraoperative vital signs will be monitored in standard fashion and used to detect development of BCIS based upon previously established criteria.
Histamine and complement levels will be measured via blood samples collected at three timepoints: pre-operation, post-induction of anesthesia, and post-cementation. The collection of these labs is for research purposes only and is not part of routine care. Postoperative complications within 30-days of the index surgery will be identified via chart review. Thus, the study duration is 30 days for each patient and requires one visit (hospitalization with index surgery).
Patients that are randomly assigned to neuraxial anesthesia but require conversion to general anesthesia due to unsuccessful spinal or epidural will be considered a treatment failure. These patients will be analyzed per protocol.
- Conditions
- Bone Cement Implantation Syndrome
- Being tested
- Administration of general anaesthesia, Neuraxial Analgesia
- Keywords
- Bone Cement Implantation Syndrome, Hip fracture, Anesthesia
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of general anaesthesiaProcedure or surgery
The anaesthesia will be administered intravenously
Neuraxial AnalgesiaProcedure or surgery
Will be administered as an epidural
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Active comparator | Patients undergoing cemented hemiarthroplasty under general anesthesia Receives: Procedure: Administration of general anaesthesia |
| Neuraxial Anesthesia | Active comparator | Patients undergoing cemented hemiarthroplasty under neuraxial anesthesia Receives: Procedure: Neuraxial Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Hypoxia
Grade 1 BCIS, defined as moderate intraoperative hypoxia (<94%) or drop in systolic blood pressure of >20%) intraoperatively.
Grade 2 BCIS, defined as severe hypoxia (<88%) or drop in systolic hypotension >40%.
Grade 3 BCIS, defined as cardiovascular collapse requiring cardiopulmonary resuscitation.
Measured: Intra-operatively, approximately 10 minutes
Secondary outcomes (2)
Systolic and Diastolic Blood Pressure (mmHg)
Blood pressure will be monitored at two independent time points: (1) immediately before cement injection and (2) Intraoperative nadir after cement injection.
Measured: Immediately before injection, int-operative up to 10 minutes
Oxygen Saturation
Oxygen saturation will be monitored at two independent time points: (1) immediately before cement injection and (2) Intraoperative nadir after cement injection.
Measured: Immediately before injection, intr-operative up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start10 Jan 2027 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone Cement Implantation SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam S. Levin, MD, Principal investigator, Johns Hopkins Hospital, Dept Orthopedic Surgery, Baltimore, MD 21287
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952257
- Sponsor's protocol ID
- IRB00462108
- Acronym
- BCIS
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zastrow RK, Rao SS, Morris CD, Levin AS. The Effect of Anesthetic Regimen on Bone Cement Implantation Syndrome in Cemented Hemiarthroplasty for Hip Fracture. J Am Acad Orthop Surg. 2025 Jan 1;33(1):e46-e57. doi: 10.5435/JAAOS-D-24-00239. Epub 2024 Aug 30.
PubMed 39231275Rao SS, Suresh KV, Margalit A, Morris CD, Levin AS. Regional or Neuraxial Anesthesia May Help Mitigate the Effects of Bone Cement Implantation Syndrome in Patients Undergoing Cemented Hip and Knee Arthroplasty for Oncologic Indications. J Am Acad Orthop Surg. 2022 Feb 1;30(3):e375-e383. doi: 10.5435/JAAOS-D-21-00553.
PubMed 34844261
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Relationship Between Anesthetic Regimen and Bone Cement Implantation Syndrome
- ClinicalTrials.gov ID
- NCT06952257
- Acronym / sponsor ID
- BCIS / IRB00462108
- Conditions
- Bone Cement Implantation Syndrome
- Keywords
- Bone Cement Implantation Syndrome, Hip fracture, Anesthesia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 10 Jan 2027 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 30 Apr 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.
The annual incidence of geriatric hip fractures in the United States is 325,000 and is projected to rise given the aging population.1 The mainstay of treatment is cemented hip hemiarthroplasty. Bone cement implantation syndrome (BCIS) is a serious perioperative complication unique to cemented arthroplasty characterized by hypoxia, hypotension, cardiac arrhythmias, and in severe cases, cardiac arrest. BCIS is associated with significantly higher rates of unplanned intubation, vasopressor use, prolonged hospitalization, and 30-day mortality.
Given the rising incidence of hip fractures, the identification of readily modifiable risk factors for BCIS such as anesthetic regimen is crucial to reduce morbidity and mortality. However, a prospective study comparing the rate of BCIS development between general and neuraxial anesthesia is currently lacking. Additionally, no studies have examined how the anesthetic regimen affects histamine and complement levels. Therefore, this pilot study aims to investigate the effect of anesthetic regimen on BCIS development as well as on histamine and complement levels in patients undergoing cemented hemiarthroplasty for hip fracture. The investigators hypothesize that neuraxial anesthesia will be associated with lower rates of BCIS as well as lower histamine and complement levels compared to general anesthesia.
The primary objective of this pilot study is to compare the effect of general and neuraxial anesthesia on the incidence and severity of BCIS in patients undergoing cemented hemiarthroplasty for hip fracture.
Secondary objectives include examining postoperative outcomes associated with BCIS, such as cardiac arrhythmias, unplanned intubation, hypoxia necessitating supplemental oxygen, altered mental status, and in-hospital mortality.
Additional objectives include comparing histamine and complement levels between anesthetic regimens as well as between patients with and without BCIS
Detailed description
This study will be a prospective, randomized pilot study involving adult patients undergoing cemented hemiarthroplasty for hip fracture within the Johns Hopkins healthcare system. In total, 20-24 participants will be randomly assigned to receive either general anesthesia or neuraxial anesthesia with sedation. The use of general or neuraxial anesthesia in this study is consistent with the current standard of care for hip hemiarthroplasty. Randomization will be performed via computer-generated sequences and allocation concealment will be maintained. Blinding patients, anesthesiologists, and orthopedic surgeons to the anesthetic regimen is not possible, but the investigator(s) conducting the statistical analyses will be blinded to the anesthesic regimen.
Patients presenting to the Johns Hopkins system with a hip fracture will be screened for possible participation. If eligible for inclusion, informed consent will be obtained from the patient preoperatively. Patients will subsequently undergo a cemented hip hemiarthroplasty with an orthopedic surgeon under either general or neuraxial anesthesia. Intraoperative vital signs will be monitored in standard fashion and used to detect development of BCIS based upon previously established criteria.
Histamine and complement levels will be measured via blood samples collected at three timepoints: pre-operation, post-induction of anesthesia, and post-cementation. The collection of these labs is for research purposes only and is not part of routine care. Postoperative complications within 30-days of the index surgery will be identified via chart review. Thus, the study duration is 30 days for each patient and requires one visit (hospitalization with index surgery).
Patients that are randomly assigned to neuraxial anesthesia but require conversion to general anesthesia due to unsuccessful spinal or epidural will be considered a treatment failure. These patients will be analyzed per protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Active comparator | Procedure: Administration of general anaesthesiaPatients undergoing cemented hemiarthroplasty under general anesthesia |
| Neuraxial Anesthesia | Active comparator | Procedure: Neuraxial AnalgesiaPatients undergoing cemented hemiarthroplasty under neuraxial anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >18 years old that are indicated for cemented hemiarthroplasty for hip fracture.
Key exclusion criteria (2 listed)
- Patients with medical comorbidities that preclude randomization to an anesthetic regimen (e.g., severe aortic stenosis contraindicating general anesthesia or therapeutic anticoagulation contraindicating neuraxial anesthesia) or
- a severe cognitive impairment that precludes the ability to provide informed consent.
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 |
|---|---|---|
| Administration of general anaesthesiaThe anaesthesia will be administered intravenously | Procedure or surgery | General Anesthesia |
| Neuraxial AnalgesiaWill be administered as an epidural | Procedure or surgery | Neuraxial Anesthesia |
Primary outcome
Number of Participants with Hypoxia
Time frame: Intra-operatively, approximately 10 minutes
Grade 1 BCIS, defined as moderate intraoperative hypoxia (<94%) or drop in systolic blood pressure of >20%) intraoperatively. Grade 2 BCIS, defined as severe hypoxia (<88%) or drop in systolic hypotension >40%. Grade 3 BCIS, defined as cardiovascular collapse requiring cardiopulmonary resuscitation.
2 secondary outcomes
Systolic and Diastolic Blood Pressure (mmHg)
Time frame: Immediately before injection, int-operative up to 10 minutes
Oxygen Saturation
Time frame: Immediately before injection, intr-operative up to 10 minutes
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 21 Jul 2026.
- Background: PubMed 39231275Zastrow RK, Rao SS, Morris CD, Levin AS. The Effect of Anesthetic Regimen on Bone Cement Implantation Syndrome in Cemented Hemiarthroplasty for Hip Fracture. J Am Acad Orthop Surg. 2025 Jan 1;33(1):e46-e57. doi: 10.5435/JAAOS-D-24-00239. Epub 2024 Aug 30.
- Background: PubMed 34844261Rao SS, Suresh KV, Margalit A, Morris CD, Levin AS. Regional or Neuraxial Anesthesia May Help Mitigate the Effects of Bone Cement Implantation Syndrome in Patients Undergoing Cemented Hip and Knee Arthroplasty for Oncologic Indications. J Am Acad Orthop Surg. 2022 Feb 1;30(3):e375-e383. doi: 10.5435/JAAOS-D-21-00553.
- 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.
Adam S. Levin, MD principal investigator
Johns Hopkins Hospital, Dept Orthopedic Surgery, Baltimore, MD 21287
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of general anaesthesia and Neuraxial Analgesia in people with Bone Cement Implantation Syndrome, run by Johns Hopkins University 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 2 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: enrolling by invitation, as of the sponsor's last update on 21 Jul 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.
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?
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?
Number of Participants with Hypoxia (time frame: Intra-operatively, approximately 10 minutes). 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 NCT06952257, which also lists 2 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 21 Jul 2026.