Pelvic Ring FractureNCT05606042
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
An observational study of Pelvic Ring Fracture and Acetabular Fracture, run by CurvaFix, Inc. at 6 sites in United States.
Trial summary
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pelvic Ring Fracture, Acetabular Fracture, Pelvic Fracture
- What is being tested?
- IM Implant
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 Nov 2021to 9 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be selected from medical facility study sites that have agreed to participate in the study.
Who may be able to join
- Subject, or their Authorized Representative, is willing and able to provide written informed consent, including authorization to release health information
- Subject has undergone pelvic or acetabular fixation using the IM Implant and the IM Implant was placed according to the manufacturer's labeling.
- Subject's pelvic or acetabular fixation with the IM Implant occurred within the last 30 calendar days.
Who cannot join
- Subject is unwilling or unable to provide written informed consent and/or does not have an authorized representative who can provide consent on their behalf
- Subject presents with any condition or situation which, in the Investigator's opinion, puts the Subject at risk, could confound the study results, or may interfere with the Subject's participation in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Missouri Orthopaedic Institute
Columbia, Missouri, 65212
Prisma Health
Columbia, South Carolina, 29203
Mount Carmel Research Institute
Columbus, Ohio, 43219
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
UT Health San Antonio
San Antonio, Texas, 78229
Memorial Medical Center, Springfield
Springfield, Illinois, 62781
About this study
Official title: Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Performance Evaluation
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
Read the detailed description
This study will evaluate the use and performance of the Curvafix IM intramedullary system for pelvic fixation in a post-market setting. Study participants will undergo follow-up care per institutional practice and data will then be collected from participant medical records. There will be no active patient participation requirements outside of standard of care. Any follow up evaluations will be documented and reported through 6 months post-implantation. The study will evaluate secondary surgical interventions as a primary study endpoint. Data will also be collected and analyzed for pelvic reduction stability, fracture healing, participant mobility/ambulation, and general health economics.
- Being tested
- IM Implant
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM ImplantDevice
Patients that have had surgical interventions with one or more IM Implant as part of standard of care for a pelvic and/or acetabular fracture
| Study group | Role | What they receive |
|---|---|---|
| IM Implant | Male and female patients who present with a pelvic ring and/or acetabular fracture that has recently undergone surgery to be fixed with a CurvaFix IM Implant. Receives: Device: IM Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary Surgical Interventions (SSIs)
Performance will be evaluated based upon the number of Secondary Surgical Interventions (SSIs) that occur within the subject's participation as identified through a review of subject medical records.
Measured: 6 months post-implantation
Secondary outcomes (3)
Mobility
Mobility (ability to advance to weight bearing) assessed by medical record review
Measured: 6 months post-implantation
Pelvic Reduction Stability
Pelvic reduction stability (ability to maintain reduction over time) assessed by medical record review
Measured: 6 months post-implantation
Health Economics
General health economics (length of hospital stay) assessed by medical record review
Measured: 6 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start24 Nov 2021
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Ring FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- CurvaFix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Hebert, Study director, Clin-Assist, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606042
- Sponsor's protocol ID
- CLP-0002
- Other IDs
- ACTRN12622001125718
- Status last verified
- Jun 2023
- First submitted
- 31 Oct 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Performance Evaluation
- ClinicalTrials.gov ID
- NCT05606042
- Acronym / sponsor ID
- CLP-0002
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 53 participants (actual)
- Lead sponsor
- CurvaFix, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 4 Nov 2022 (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.
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
Detailed description
This study will evaluate the use and performance of the Curvafix IM intramedullary system for pelvic fixation in a post-market setting. Study participants will undergo follow-up care per institutional practice and data will then be collected from participant medical records. There will be no active patient participation requirements outside of standard of care. Any follow up evaluations will be documented and reported through 6 months post-implantation. The study will evaluate secondary surgical interventions as a primary study endpoint. Data will also be collected and analyzed for pelvic reduction stability, fracture healing, participant mobility/ambulation, and general health economics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IM Implant | – | Device: IM ImplantMale and female patients who present with a pelvic ring and/or acetabular fracture that has recently undergone surgery to be fixed with a CurvaFix IM Implant. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be selected from medical facility study sites that have agreed to participate in the study.
Key inclusion criteria (3 listed)
- Subject, or their Authorized Representative, is willing and able to provide written informed consent, including authorization to release health information
- Subject has undergone pelvic or acetabular fixation using the IM Implant and the IM Implant was placed according to the manufacturer's labeling.
- Subject's pelvic or acetabular fixation with the IM Implant occurred within the last 30 calendar days.
Key exclusion criteria (2 listed)
- Subject is unwilling or unable to provide written informed consent and/or does not have an authorized representative who can provide consent on their behalf
- Subject presents with any condition or situation which, in the Investigator's opinion, puts the Subject at risk, could confound the study results, or may interfere with the Subject's participation in the study
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 |
|---|---|---|
| IM ImplantPatients that have had surgical interventions with one or more IM Implant as part of standard of care for a pelvic and/or acetabular fracture | Device | IM Implant |
Primary outcome
Secondary Surgical Interventions (SSIs)
Time frame: 6 months post-implantation
Performance will be evaluated based upon the number of Secondary Surgical Interventions (SSIs) that occur within the subject's participation as identified through a review of subject medical records.
3 secondary outcomes
Mobility
Time frame: 6 months post-implantation
Pelvic Reduction Stability
Time frame: 6 months post-implantation
Health Economics
Time frame: 6 months post-implantation
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- 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. This study is not recruiting at the moment.
Jennifer Hebert study director
Clin-Assist, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Ring Fracture and Acetabular Fracture, run by CurvaFix, Inc. at 6 sites 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 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: stopped early, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
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?
Secondary Surgical Interventions (SSIs) (time frame: 6 months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2026.