Weight-bearing of Patients After Pelvic Ring FractureRECFAPNCT06481865
Weight-bearing of Patients After Pelvic Ring Fracture
An observational study of Weight-bearing of Patients After Pelvic Ring Fracture, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Pelvic ring fractures are fractures associated with high morbidity and mortality. When the fracture is displaced, surgical management to achieve reduction and fixation of the anterior and posterior annulus is the current reference. The optimal technique that gives the best results is controversial. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Weight-bearing of Patients After Pelvic Ring Fracture
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2024to 1 Jun 2025
- How long will I take part?
- 1 Year
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated in the orthopedics and traumatology department at CHU de Grenoble Alpes between 01/01/2020 and 31/12/2022 for a pelvic ring fracture are selected for the monocentric observational study. Epidemiological data, preoperative management, fracture patterns according to classification (Tile and AO/OTA), operative data, and radiological criteria (X-rays and CT scans) are collected and analyzed retrospectively
Who may be able to join
- Adult patient at the time of injury
- Pelvic ring fracture
- Pre-operative X-rays
- Pre-operative CT scan
- Post-operative X-rays
- Postoperative CT scan
- Willingness and ability to participate in the study.
Who cannot join
- Ipsi-lateral fracture of the femoral and/or associated acetabulum (Floating Hip C or B)
- Pregnant and breastfeeding women
- People under guardianship, protected adults
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble Alpes university Hospital,La tronche
Grenoble
Sarah KASSAR-UNEISI, Pharm D, 0033476767524, SUneisi@chu-grenoble.fr
Mehdi BOUDISSA, Pr
About this study
Official title: Weight-bearing of Patients After Pelvic Ring Fracture: A Monocentric Observational Study
Pelvic ring fractures are fractures associated with high morbidity and mortality. When the fracture is displaced, surgical management to achieve reduction and fixation of the anterior and posterior annulus is the current reference. The optimal technique that gives the best results is controversial. Open reductions and internal fixations (ORIFs) are associated with more blood loss and a higher rate of infection, while closed reductions and percutaneous fixations (CRPF) are associated with more screw misplacements and thus vascular or nerve damage. The results appear to be similar in the literature between the two approaches
Surgery for pelvic ring fractures has become increasingly common over the past three decades Recovery is often delayed for weeks post-surgery, depending on the center. Modern management emphasizes early rehabilitation, including early mobility and weight-bearing, when possible. Increasing the number of screws, their diameter and length, and systematically fixing both anterior and posterior lesions add safety for early reloading
Read more
The aim of the study is The main objective of the study is to evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture in a large cohort of patients at Grenoble University Hospital, compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing.
The investigator hypothesize that early weight-bearing of pelvic ring fractures with biomechanically stable fixation does not result in significant differences in clinical outcomes at a minimum of one year compared to patients with delayed weight-bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early weight-bearing of patients operated on for a pelvic ring fracture | Clinical outcomes and complications will be compared between the two groups | |
| Delayed weight -bearing of patients operated on for a pelvic ring fracture | Clinical outcomes and complications will be compared between the two groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing
Clinical outcomes according to functional assessment ( Majeed score)
Measured: 1 year
Secondary outcomes (5)
Define the prognostic factors associated with poor clinical outcomes and Pseudoarthrosis or vicious callus.
Prognostic factors from operative data (Ilio-inguinale,Ilio-stoppa,stoppa,stoppa + external window,kocher-Langenbeck, anterior + posterior, operating time (min), blood loss (ml),intraoperative re-transfusion (ml))
Measured: 1 year
Compare clinical outcomes and radiological results with the literature
Clinical outcomes according to functional assessment (MAJEED score)
Measured: 1 year
Compare clinical outcomes and radiological results with the literature
Clinical outcomes according to Numerical Pain Scale (from 0 to 10) 0 no pain 10 worst possible pain
Measured: 1 year
Compare clinical outcomes and radiological results with the literature
Clinical outcomes according to radiological results
Measured: 1 year
Evaluation of the outcomes and complications of immediate weight-bearing in elderly patients.
Intraoperative and postoperative complications (including complications of immediate weight-bearing)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Weight-bearing of Patients After Pelvic Ring FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Other
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehdi PI BOUDISSA, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481865
- Sponsor's protocol ID
- 2024-A00479-38
- Acronym
- RECFAP
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pennal GF, Tile M, Waddell JP, Garside H. Pelvic disruption: assessment and classification. Clin Orthop Relat Res. 1980 Sep;(151):12-21.
PubMed 7418295Ruatti S, Guillot S, Brun J, Thony F, Bouzat P, Payen JF, Tonetti J. Which pelvic ring fractures are potentially lethal? Injury. 2015;46(6):1059-63. doi: 10.1016/j.injury.2015.01.041. Epub 2015 Mar 2.
PubMed 25769199Papakostidis C, Kanakaris NK, Kontakis G, Giannoudis PV. Pelvic ring disruptions: treatment modalities and analysis of outcomes. Int Orthop. 2009 Apr;33(2):329-38. doi: 10.1007/s00264-008-0555-6. Epub 2008 May 7.
PubMed 18461325Routt ML Jr, Kregor PJ, Simonian PT, Mayo KA. Early results of percutaneous iliosacral screws placed with the patient in the supine position. J Orthop Trauma. 1995 Jun;9(3):207-14. doi: 10.1097/00005131-199506000-00005.
PubMed 7623172Goldstein A, Phillips T, Sclafani SJ, Scalea T, Duncan A, Goldstein J, Panetta T, Shaftan G. Early open reduction and internal fixation of the disrupted pelvic ring. J Trauma. 1986 Apr;26(4):325-33. doi: 10.1097/00005373-198604000-00004.
PubMed 3959137Lindsay A, Tornetta P 3rd, Diwan A, Templeman D. Is Closed Reduction and Percutaneous Fixation of Unstable Posterior Ring Injuries as Accurate as Open Reduction and Internal Fixation? J Orthop Trauma. 2016 Jan;30(1):29-33. doi: 10.1097/BOT.0000000000000418.
PubMed 26270459Melhem E, Riouallon G, Habboubi K, Gabbas M, Jouffroy P. Epidemiology of pelvic and acetabular fractures in France. Orthop Traumatol Surg Res. 2020 Sep;106(5):831-839. doi: 10.1016/j.otsr.2019.11.019. Epub 2020 Feb 1.
PubMed 32019733Herteleer M, Dejaeger M, Nijs S, Hoekstra H, Laurent MR. Epidemiology and secular trends of pelvic fractures in Belgium: A retrospective, population-based, nationwide observational study. Bone. 2021 Dec;153:116141. doi: 10.1016/j.bone.2021.116141. Epub 2021 Aug 5.
PubMed 34365026Rickman M, Link BC, Solomon LB. Patient Weight-bearing after Pelvic Fracture Surgery-A Systematic Review of the Literature: What is the Modern Evidence Base? Strategies Trauma Limb Reconstr. 2019 Jan-Apr;14(1):45-52. doi: 10.5005/jp-journals-10080-1414.
PubMed 32559267Tonetti J, Carrat L, Lavallee S, Pittet L, Merloz P, Chirossel JP. Percutaneous iliosacral screw placement using image guided techniques. Clin Orthop Relat Res. 1998 Sep;(354):103-10. doi: 10.1097/00003086-199809000-00013.
PubMed 9755769Tonetti J. Management of recent unstable fractures of the pelvic ring. An update conference supported by the Club Bassin Cotyle. (Pelvis-Acetabulum Club). Orthop Traumatol Surg Res. 2013 Feb;99(1 Suppl):S77-86. doi: 10.1016/j.otsr.2012.11.013. Epub 2013 Feb 4.
PubMed 23380433Lichte P, Alabdulrhaman H, Pishnamaz M, Hofman M, Hildebrand F, Kobbe P. [Percutaneous screw techniques for the pelvic ring and acetabulum]. Unfallchirurg. 2019 May;122(5):387-403. doi: 10.1007/s00113-019-0648-2. German.
PubMed 31025047Boudissa M, Roudet A, Fumat V, Ruatti S, Kerschbaumer G, Milaire M, Merloz P, Tonetti J. Part 1: Outcome of Posterior Pelvic Ring Injuries and Associated Prognostic Factors - A Five-Year Retrospective Study of One Hundred and Sixty Five Operated Cases with Closed Reduction and Percutaneous Fixation. Int Orthop. 2020 Jun;44(6):1209-1215. doi: 10.1007/s00264-020-04574-1. Epub 2020 Apr 23.
PubMed 32328739Boudissa M, Carmagnac D, Kerschbaumer G, Ruatti S, Tonetti J. Screw misplacement in percutaneous posterior pelvic iliosacral screwing with and without navigation: A prospective clinical study of 174 screws in 127 patients. Orthop Traumatol Surg Res. 2022 Apr;108(2):103213. doi: 10.1016/j.otsr.2022.103213. Epub 2022 Jan 23.
PubMed 35081456Rommens PM. Is there a role for percutaneous pelvic and acetabular reconstruction? Injury. 2007 Apr;38(4):463-77. doi: 10.1016/j.injury.2007.01.025. Epub 2007 Mar 29.
PubMed 17397846
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight-bearing of Patients After Pelvic Ring Fracture: A Monocentric Observational Study
- ClinicalTrials.gov ID
- NCT06481865
- Acronym / sponsor ID
- RECFAP / 2024-A00479-38
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 1 Jul 2024 (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.
Pelvic ring fractures are fractures associated with high morbidity and mortality. When the fracture is displaced, surgical management to achieve reduction and fixation of the anterior and posterior annulus is the current reference. The optimal technique that gives the best results is controversial. Open reductions and internal fixations (ORIFs) are associated with more blood loss and a higher rate of infection, while closed reductions and percutaneous fixations (CRPF) are associated with more screw misplacements and thus vascular or nerve damage. The results appear to be similar in the literature between the two approaches
Surgery for pelvic ring fractures has become increasingly common over the past three decades Recovery is often delayed for weeks post-surgery, depending on the center. Modern management emphasizes early rehabilitation, including early mobility and weight-bearing, when possible. Increasing the number of screws, their diameter and length, and systematically fixing both anterior and posterior lesions add safety for early reloading
The aim of the study is The main objective of the study is to evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture in a large cohort of patients at Grenoble University Hospital, compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing.
The investigator hypothesize that early weight-bearing of pelvic ring fractures with biomechanically stable fixation does not result in significant differences in clinical outcomes at a minimum of one year compared to patients with delayed weight-bearing
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early weight-bearing of patients operated on for a pelvic ring fracture | – | –Clinical outcomes and complications will be compared between the two groups |
| Delayed weight -bearing of patients operated on for a pelvic ring fracture | – | –Clinical outcomes and complications will be compared between the two groups |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated in the orthopedics and traumatology department at CHU de Grenoble Alpes between 01/01/2020 and 31/12/2022 for a pelvic ring fracture are selected for the monocentric observational study. Epidemiological data, preoperative management, fracture patterns according to classification (Tile and AO/OTA), operative data, and radiological criteria (X-rays and CT scans) are collected and analyzed retrospectively
Key inclusion criteria (7 listed)
- Adult patient at the time of injury
- Pelvic ring fracture
- Pre-operative X-rays
- Pre-operative CT scan
- Post-operative X-rays
Key exclusion criteria (3 listed)
- Ipsi-lateral fracture of the femoral and/or associated acetabulum (Floating Hip C or B)
- Pregnant and breastfeeding women
- People under guardianship, protected adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing
Time frame: 1 year
Clinical outcomes according to functional assessment ( Majeed score)
5 secondary outcomes
Define the prognostic factors associated with poor clinical outcomes and Pseudoarthrosis or vicious callus.
Time frame: 1 year
Compare clinical outcomes and radiological results with the literature
Time frame: 1 year
Compare clinical outcomes and radiological results with the literature
Time frame: 1 year
Compare clinical outcomes and radiological results with the literature
Time frame: 1 year
Evaluation of the outcomes and complications of immediate weight-bearing in elderly patients.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Background: PubMed 7418295Pennal GF, Tile M, Waddell JP, Garside H. Pelvic disruption: assessment and classification. Clin Orthop Relat Res. 1980 Sep;(151):12-21.
- Background: PubMed 25769199Ruatti S, Guillot S, Brun J, Thony F, Bouzat P, Payen JF, Tonetti J. Which pelvic ring fractures are potentially lethal? Injury. 2015;46(6):1059-63. doi: 10.1016/j.injury.2015.01.041. Epub 2015 Mar 2.
- Background: PubMed 18461325Papakostidis C, Kanakaris NK, Kontakis G, Giannoudis PV. Pelvic ring disruptions: treatment modalities and analysis of outcomes. Int Orthop. 2009 Apr;33(2):329-38. doi: 10.1007/s00264-008-0555-6. Epub 2008 May 7.
- Background: PubMed 7623172Routt ML Jr, Kregor PJ, Simonian PT, Mayo KA. Early results of percutaneous iliosacral screws placed with the patient in the supine position. J Orthop Trauma. 1995 Jun;9(3):207-14. doi: 10.1097/00005131-199506000-00005.
- Background: PubMed 3959137Goldstein A, Phillips T, Sclafani SJ, Scalea T, Duncan A, Goldstein J, Panetta T, Shaftan G. Early open reduction and internal fixation of the disrupted pelvic ring. J Trauma. 1986 Apr;26(4):325-33. doi: 10.1097/00005373-198604000-00004.
- Background: PubMed 26270459Lindsay A, Tornetta P 3rd, Diwan A, Templeman D. Is Closed Reduction and Percutaneous Fixation of Unstable Posterior Ring Injuries as Accurate as Open Reduction and Internal Fixation? J Orthop Trauma. 2016 Jan;30(1):29-33. doi: 10.1097/BOT.0000000000000418.
- Background: PubMed 32019733Melhem E, Riouallon G, Habboubi K, Gabbas M, Jouffroy P. Epidemiology of pelvic and acetabular fractures in France. Orthop Traumatol Surg Res. 2020 Sep;106(5):831-839. doi: 10.1016/j.otsr.2019.11.019. Epub 2020 Feb 1.
- Background: PubMed 34365026Herteleer M, Dejaeger M, Nijs S, Hoekstra H, Laurent MR. Epidemiology and secular trends of pelvic fractures in Belgium: A retrospective, population-based, nationwide observational study. Bone. 2021 Dec;153:116141. doi: 10.1016/j.bone.2021.116141. Epub 2021 Aug 5.
- Background: PubMed 32559267Rickman M, Link BC, Solomon LB. Patient Weight-bearing after Pelvic Fracture Surgery-A Systematic Review of the Literature: What is the Modern Evidence Base? Strategies Trauma Limb Reconstr. 2019 Jan-Apr;14(1):45-52. doi: 10.5005/jp-journals-10080-1414.
- Background: PubMed 9755769Tonetti J, Carrat L, Lavallee S, Pittet L, Merloz P, Chirossel JP. Percutaneous iliosacral screw placement using image guided techniques. Clin Orthop Relat Res. 1998 Sep;(354):103-10. doi: 10.1097/00003086-199809000-00013.
- Background: PubMed 23380433Tonetti J. Management of recent unstable fractures of the pelvic ring. An update conference supported by the Club Bassin Cotyle. (Pelvis-Acetabulum Club). Orthop Traumatol Surg Res. 2013 Feb;99(1 Suppl):S77-86. doi: 10.1016/j.otsr.2012.11.013. Epub 2013 Feb 4.
- Background: PubMed 31025047Lichte P, Alabdulrhaman H, Pishnamaz M, Hofman M, Hildebrand F, Kobbe P. [Percutaneous screw techniques for the pelvic ring and acetabulum]. Unfallchirurg. 2019 May;122(5):387-403. doi: 10.1007/s00113-019-0648-2. German.
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.
Mehdi PI BOUDISSA principal investigator
Grenoble Alpes University Hospital
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 Weight-bearing of Patients After Pelvic Ring Fracture, run by University Hospital, Grenoble at 1 site in France.
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 7 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehdi PI BOUDISSA, Pr (0476769693, MBoudissa@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing (time frame: 1 year). 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 NCT06481865, which also lists 24 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 1 Jul 2024.