Periprosthetic Fracture of the FemurNCT02854566
Periprosthetic Fractures of the Femur Treated by Osteosynthesis
An observational study of Periprosthetic Fracture of the Femur, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Observational retrospective study on 36 consecutive patients having had surgery for a periprosthetic fracture of the femur between 2010 and 2015. The goal of the study is to test whether osteosynthesis was a secure choice at a certain age and with any type of Vancouver fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Fracture of the Femur
- What is being tested?
- osteosynthesis
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to 23 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Periprosthetic fractures of the femur treated by osteosynthesis
Who may be able to join
- Consecutive patients having had surgery between 2010 and 2015 within the CHU Brugmann hospital for a periprosthetic fracture of the femur (osteosynthesis).
Who cannot join
- Death during surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Observational retrospective study on 36 consecutive patients having had surgery for a periprosthetic fracture of the femur between 2010 and 2015.
The goal of the study is to test whether osteosynthesis was a secure choice at a certain age and with any type of Vancouver fracture.
- Conditions
- Periprosthetic Fracture of the Femur
- Being tested
- osteosynthesis
- Keywords
- periprosthetic fracture of the femur, hip prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteosynthesisDevice
Fracture reduction and fixation with screws/plates/cables (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| periprosthetic fractures of the femur | periprosthetic fractures of the femur treated by osteosynthesis Receives: Device: osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Demographic data
Measured: Up to 2-3 days before surgery (pre-surgery radiography)
Sex
Demographic data
Measured: Up to 2-3 days before surgery (pre-surgery radiography)
Body Mass Index
Demographic data
Measured: Up to 2-3 days before surgery (pre-surgery radiography)
Prosthesis type
PTH (total hip prosthesis) or BHP (bipolar hip prosthesis)
Measured: Up to 2-3 days before surgery (pre-surgery radiography)
Type of fracture
Type of fracture according to the Vancouver International Classification
Measured: Up to 2-3 days before surgery (pre-surgery radiography)
Femoral component
Need for cement within the femur or not
Measured: Up to 2-3 days before surgery (pre-surgery radiography)
Time between 1st surgery and fracture
Time between 1st surgery and fracture
Measured: Up to 2-3 days before surgery (pre-surgery radiography)
Fracture healing
Healing status of the fracture (healed/not healed)
Measured: 10 months after surgery
Mortality rate
Mortality rate (any causes)
Measured: 10 months after surgery
Complications rate
Total complications rate (local + systemic + implant)
Measured: 10 months after surgery
ASA score
ASA score
Measured: During surgery (up to 2 hours)
Blood loss
Blood loss during surgery
Measured: During surgery (up to 2 hours)
Secondary outcomes (1)
Laterality
Prosthesis on the right or on the left side
Measured: Up to 2-3 days before surgery (pre-surgery radiography)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJun 2016
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic Fracture of the FemurStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamas Illes, Brugmann University Hospital
- Investigators
- Dragos Schiopu, MD, Principal investigator, CHU BrugmannTamas Illes, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854566
- Sponsor's protocol ID
- CHUB-Periprosthetic fractures
- Status last verified
- Jul 2022
- First submitted
- 1 Aug 2016
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaski GE, Scully SP. In brief: classifications in brief: Vancouver classification of postoperative periprosthetic femur fractures. Clin Orthop Relat Res. 2011 May;469(5):1507-10. doi: 10.1007/s11999-010-1532-0. No abstract available.
PubMed 20809166Duncan CP, Haddad FS. The Unified Classification System (UCS): improving our understanding of periprosthetic fractures. Bone Joint J. 2014 Jun;96-B(6):713-6. doi: 10.1302/0301-620X.96B6.34040.
PubMed 24891568Lindahl H, Malchau H, Oden A, Garellick G. Risk factors for failure after treatment of a periprosthetic fracture of the femur. J Bone Joint Surg Br. 2006 Jan;88(1):26-30. doi: 10.1302/0301-620X.88B1.17029.
PubMed 16365115Laurer HL, Wutzler S, Possner S, Geiger EV, El Saman A, Marzi I, Frank J. Outcome after operative treatment of Vancouver type B1 and C periprosthetic femoral fractures: open reduction and internal fixation versus revision arthroplasty. Arch Orthop Trauma Surg. 2011 Jul;131(7):983-9. doi: 10.1007/s00402-011-1272-y. Epub 2011 Feb 18.
PubMed 21331551Learmonth ID. The management of periprosthetic fractures around the femoral stem. J Bone Joint Surg Br. 2004 Jan;86(1):13-9. No abstract available.
PubMed 14765858Corten K, Vanrykel F, Bellemans J, Frederix PR, Simon JP, Broos PL. An algorithm for the surgical treatment of periprosthetic fractures of the femur around a well-fixed femoral component. J Bone Joint Surg Br. 2009 Nov;91(11):1424-30. doi: 10.1302/0301-620X.91B11.22292.
PubMed 19880884Capello WN, D'Antonio JA, Naughton M. Periprosthetic fractures around a cementless hydroxyapatite-coated implant: a new fracture pattern is described. Clin Orthop Relat Res. 2014 Feb;472(2):604-10. doi: 10.1007/s11999-013-3137-x.
PubMed 23836241Niikura T, Sakurai A, Oe K, Shibanuma N, Tsunoda M, Maruo A, Shoda E, Lee SY, Sakai Y, Kurosaka M. Clinical and radiological results of locking plate fixation for periprosthetic femoral fractures around hip arthroplasties: a retrospective multi-center study. J Orthop Sci. 2014 Nov;19(6):984-90. doi: 10.1007/s00776-014-0622-3. Epub 2014 Aug 22.
PubMed 25145998Choo SK, Kim Y, Shin MJ, Oh HK. Conservative treatment after failure of internal fixation for periprosthetic femoral fractures: a report of two cases. Arch Orthop Trauma Surg. 2015 Jun;135(6):773-9. doi: 10.1007/s00402-015-2210-1. Epub 2015 Apr 18.
PubMed 25894000Baba T, Kaneko K, Shitoto K, Futamura K, Maruyama Y. Comparison of therapeutic outcomes of periprosthetic femoral fracture between treatments employing locking and conventional plates. Eur J Orthop Surg Traumatol. 2013 May;23(4):437-41. doi: 10.1007/s00590-012-1005-0. Epub 2012 May 17.
PubMed 23412148Muller FJ, Galler M, Fuchtmeier B. Clinical and radiological results of patients treated with orthogonal double plating for periprosthetic femoral fractures. Int Orthop. 2014 Dec;38(12):2469-72. doi: 10.1007/s00264-014-2464-1. Epub 2014 Aug 12.
PubMed 25109478Moloney GB, Westrick ER, Siska PA, Tarkin IS. Treatment of periprosthetic femur fractures around a well-fixed hip arthroplasty implant: span the whole bone. Arch Orthop Trauma Surg. 2014 Jan;134(1):9-14. doi: 10.1007/s00402-013-1883-6. Epub 2013 Nov 20.
PubMed 24253261
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periprosthetic Fractures of the Femur Treated by Osteosynthesis
- ClinicalTrials.gov ID
- NCT02854566
- Acronym / sponsor ID
- CHUB-Periprosthetic fractures
- Conditions
- Periprosthetic Fracture of the Femur
- Keywords
- periprosthetic fracture of the femur, hip prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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.
Observational retrospective study on 36 consecutive patients having had surgery for a periprosthetic fracture of the femur between 2010 and 2015.
The goal of the study is to test whether osteosynthesis was a secure choice at a certain age and with any type of Vancouver fracture.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| periprosthetic fractures of the femur | – | Device: osteosynthesisperiprosthetic fractures of the femur treated by osteosynthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Periprosthetic fractures of the femur treated by osteosynthesis
Key inclusion criteria (1 listed)
- Consecutive patients having had surgery between 2010 and 2015 within the CHU Brugmann hospital for a periprosthetic fracture of the femur (osteosynthesis).
Key exclusion criteria (1 listed)
- Death during surgery.
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 |
|---|---|---|
| osteosynthesisFracture reduction and fixation with screws/plates/cables (standard of care) | Device | periprosthetic fractures of the femur |
Primary outcome
Age
Time frame: Up to 2-3 days before surgery (pre-surgery radiography)
Demographic data
Sex
Time frame: Up to 2-3 days before surgery (pre-surgery radiography)
Demographic data
Body Mass Index
Time frame: Up to 2-3 days before surgery (pre-surgery radiography)
Demographic data
Prosthesis type
Time frame: Up to 2-3 days before surgery (pre-surgery radiography)
PTH (total hip prosthesis) or BHP (bipolar hip prosthesis)
Type of fracture
Time frame: Up to 2-3 days before surgery (pre-surgery radiography)
Type of fracture according to the Vancouver International Classification
Femoral component
Time frame: Up to 2-3 days before surgery (pre-surgery radiography)
Need for cement within the femur or not
Time between 1st surgery and fracture
Time frame: Up to 2-3 days before surgery (pre-surgery radiography)
Time between 1st surgery and fracture
Fracture healing
Time frame: 10 months after surgery
Healing status of the fracture (healed/not healed)
Mortality rate
Time frame: 10 months after surgery
Mortality rate (any causes)
Complications rate
Time frame: 10 months after surgery
Total complications rate (local + systemic + implant)
ASA score
Time frame: During surgery (up to 2 hours)
ASA score
Blood loss
Time frame: During surgery (up to 2 hours)
Blood loss during surgery
1 secondary outcome
Laterality
Time frame: Up to 2-3 days before surgery (pre-surgery radiography)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 20809166Gaski GE, Scully SP. In brief: classifications in brief: Vancouver classification of postoperative periprosthetic femur fractures. Clin Orthop Relat Res. 2011 May;469(5):1507-10. doi: 10.1007/s11999-010-1532-0. No abstract available.
- Background: PubMed 24891568Duncan CP, Haddad FS. The Unified Classification System (UCS): improving our understanding of periprosthetic fractures. Bone Joint J. 2014 Jun;96-B(6):713-6. doi: 10.1302/0301-620X.96B6.34040.
- Background: PubMed 16365115Lindahl H, Malchau H, Oden A, Garellick G. Risk factors for failure after treatment of a periprosthetic fracture of the femur. J Bone Joint Surg Br. 2006 Jan;88(1):26-30. doi: 10.1302/0301-620X.88B1.17029.
- Background: PubMed 21331551Laurer HL, Wutzler S, Possner S, Geiger EV, El Saman A, Marzi I, Frank J. Outcome after operative treatment of Vancouver type B1 and C periprosthetic femoral fractures: open reduction and internal fixation versus revision arthroplasty. Arch Orthop Trauma Surg. 2011 Jul;131(7):983-9. doi: 10.1007/s00402-011-1272-y. Epub 2011 Feb 18.
- Background: PubMed 14765858Learmonth ID. The management of periprosthetic fractures around the femoral stem. J Bone Joint Surg Br. 2004 Jan;86(1):13-9. No abstract available.
- Background: PubMed 19880884Corten K, Vanrykel F, Bellemans J, Frederix PR, Simon JP, Broos PL. An algorithm for the surgical treatment of periprosthetic fractures of the femur around a well-fixed femoral component. J Bone Joint Surg Br. 2009 Nov;91(11):1424-30. doi: 10.1302/0301-620X.91B11.22292.
- Background: PubMed 23836241Capello WN, D'Antonio JA, Naughton M. Periprosthetic fractures around a cementless hydroxyapatite-coated implant: a new fracture pattern is described. Clin Orthop Relat Res. 2014 Feb;472(2):604-10. doi: 10.1007/s11999-013-3137-x.
- Background: PubMed 25145998Niikura T, Sakurai A, Oe K, Shibanuma N, Tsunoda M, Maruo A, Shoda E, Lee SY, Sakai Y, Kurosaka M. Clinical and radiological results of locking plate fixation for periprosthetic femoral fractures around hip arthroplasties: a retrospective multi-center study. J Orthop Sci. 2014 Nov;19(6):984-90. doi: 10.1007/s00776-014-0622-3. Epub 2014 Aug 22.
- Background: PubMed 25894000Choo SK, Kim Y, Shin MJ, Oh HK. Conservative treatment after failure of internal fixation for periprosthetic femoral fractures: a report of two cases. Arch Orthop Trauma Surg. 2015 Jun;135(6):773-9. doi: 10.1007/s00402-015-2210-1. Epub 2015 Apr 18.
- Background: PubMed 23412148Baba T, Kaneko K, Shitoto K, Futamura K, Maruyama Y. Comparison of therapeutic outcomes of periprosthetic femoral fracture between treatments employing locking and conventional plates. Eur J Orthop Surg Traumatol. 2013 May;23(4):437-41. doi: 10.1007/s00590-012-1005-0. Epub 2012 May 17.
- Background: PubMed 25109478Muller FJ, Galler M, Fuchtmeier B. Clinical and radiological results of patients treated with orthogonal double plating for periprosthetic femoral fractures. Int Orthop. 2014 Dec;38(12):2469-72. doi: 10.1007/s00264-014-2464-1. Epub 2014 Aug 12.
- Background: PubMed 24253261Moloney GB, Westrick ER, Siska PA, Tarkin IS. Treatment of periprosthetic femur fractures around a well-fixed hip arthroplasty implant: span the whole bone. Arch Orthop Trauma Surg. 2014 Jan;134(1):9-14. doi: 10.1007/s00402-013-1883-6. Epub 2013 Nov 20.
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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.
Dragos Schiopu, MD principal investigator
CHU Brugmann
Tamas Illes, MD principal investigator
CHU Brugmann
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 of the Femur, run by Brugmann University Hospital at 1 site in Belgium.
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 1 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 Jul 2022. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Age (time frame: Up to 2-3 days before surgery (pre-surgery radiography)). The study lists 12 primary outcomes in all. 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 NCT02854566, which also lists 12 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 Jul 2022.