Periprosthetic Fracture of the Femur Clinical Trial
Official title:
Periprosthetic Fractures of the Femur Treated by Osteosynthesis
| Verified date | July 2022 |
| Source | Brugmann University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | November 23, 2020 |
| Est. primary completion date | November 23, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Consecutive patients having had surgery between 2010 and 2015 within the CHU Brugmann hospital for a periprosthetic fracture of the femur (osteosynthesis). Exclusion Criteria: - Death during surgery. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU Brugmann | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Brugmann University Hospital |
Belgium,
Baba 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. — View Citation
Capello 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. — View Citation
Choo 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. — View Citation
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Laurer 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. — View Citation
Learmonth ID. The management of periprosthetic fractures around the femoral stem. J Bone Joint Surg Br. 2004 Jan;86(1):13-9. Review. — View Citation
Lindahl H, Malchau H, Odén 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. — View Citation
Moloney 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. — View Citation
Müller FJ, Galler M, Füchtmeier 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. — View Citation
Niikura 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Age | Demographic data | Up to 2-3 days before surgery (pre-surgery radiography) | |
| Primary | Sex | Demographic data | Up to 2-3 days before surgery (pre-surgery radiography) | |
| Primary | Body Mass Index | Demographic data | Up to 2-3 days before surgery (pre-surgery radiography) | |
| Primary | Prosthesis type | PTH (total hip prosthesis) or BHP (bipolar hip prosthesis) | Up to 2-3 days before surgery (pre-surgery radiography) | |
| Primary | Type of fracture | Type of fracture according to the Vancouver International Classification | Up to 2-3 days before surgery (pre-surgery radiography) | |
| Primary | Femoral component | Need for cement within the femur or not | Up to 2-3 days before surgery (pre-surgery radiography) | |
| Primary | Time between 1st surgery and fracture | Time between 1st surgery and fracture | Up to 2-3 days before surgery (pre-surgery radiography) | |
| Primary | Fracture healing | Healing status of the fracture (healed/not healed) | 10 months after surgery | |
| Primary | Mortality rate | Mortality rate (any causes) | 10 months after surgery | |
| Primary | Complications rate | Total complications rate (local + systemic + implant) | 10 months after surgery | |
| Primary | ASA score | ASA score | During surgery (up to 2 hours) | |
| Primary | Blood loss | Blood loss during surgery | During surgery (up to 2 hours) | |
| Secondary | Laterality | Prosthesis on the right or on the left side | Up to 2-3 days before surgery (pre-surgery radiography) |