Conservative or Operative Therapy in Patients With a Fragility Fracture of the Pelvis

Pelvic Fracture Clinical Trial

Official title:

Conservative or Operative Therapy in Patients With a Fragility Fracture of the Pelvis: a Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744350
• Other study ID #: FFP1
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Luzerner Kantonsspital
• Contact: Roemalie Haveman
• Phone: 0041 79 618 9774
• Email: Roemaliehaveman[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In our society the population consists of more elderly patients. Medical treatment needs to be adjusted to this patient group. This research project focusses on patients with a fragility fracture of the pelvis. This results from a minor trauma and can cause a long immobilization period because of severe pain. For FFP type II b and II c there is no consensus on the best treatment option. Either a surgical minimal invasive sacroiliac osteosynthesis or conservative treatment is a possibility. Of course, both treatment options have pros and cons. This research project will randomize all patients with a FFP IIb or IIc fracture in either surgical or conservative treatment. These treatments will be evaluated at the follow-ups, 4 weeks, 4 months and 1 year after trauma. This will be evaluated with the DEMMI, Accelerometer, EQ-5D (EuroQol Quality of Live Questionnaire), radiological results, range of motion, pain-levels and reporting any postoperative complications or adverse events. Patient will be included over a period of 18 months and will be followed for at least a year. This research project aim to answer the question which treatment option for FFP type IIb and IIc is the most adequate.

Description:

Background. Fragility fractures of the pelvis are increasing in incidence. These are osteoporotic fractures, who result from a minor trauma. Typically, the weak osteoporotic bone is fractured, an the ligaments remain intact resulting in an undisplaced or minimally displaced pelvic ring. Fragility fractures of the pelvis can be divided in type I, II, III and IV. For type I the treatment method of choice is conservative. For type III and IV a surgical treatment is necessary. Only the ideal treatment for type II remains unclear. There is no consensus in whether conservative treatment or surgical treatment will have the best outcomes. Surgical treatment mostly means a minimal invasive osteosynthesis. In our hospital we use percutaneous sacroiliac screw fixation with augmentation. The screws used are perforated and fenestrated, allowing for a correct placement an cement augmentation. Preferably, this procedure is performed in our hybrid operation theatre. An intraoperative CT-scan can be performed. This treatment method has proven to be a safe method in literature. On the other hand, surgical treatment, can have complications and risks, especially in the elderly. Conservative treatment consist of mobilisation and physiotherapy. But conservative treatment can be limited because of uncontrolled pain, resulting in a long immobilisation period. Immobilisation in the elderly leads to several complications. This research project will focus on early operative intervention to reduce the immobilisation period and its negative consequences.

Study design. Recruitment of patients will find place in our emergency department and our outpatient clinic. A lot of patients with a FFP type IIb and IIc present themselves at our emergency department due to immobilising pain. All the elderly patient who complain about sacroiliac pain will receive an CT-scan. Literature showed that an conventional x-ray is not sufficient to detect sacroiliac fractures. On the other hand a lot of patient are referred to our outpatient clinic by other hospitals in our region or even general practioners. All these patients, who meet our inclusion criteria, will be asked for informed consent. After informed consent has been collected, patients will be randomised to on of the groups. The first group will receive surgical treatment and the second group will receive conservative treatment. Randomisation is performed with a vending machine. Depending on which soda can comes out, patients are assigned to the groups.

Study intervention. As stated before the are two groups in this research project. Both treatment are standard treatments. Both groups will receive a standard set of co-interventions, such as adequate analgesics and intensive physiotherapy. At our hospital a geriatric trauma centre is established. After discharge or 4 weeks after trauma a first follow-up is planned. This is primary for the treatment evaluation. Then after 4 months are second follow-up is planned with a traumatologist, physiotherapist and a geriatric specialist. At this follow-up several benchmark test are performed, such as the DEMMI, EQ 5D and an accelerometer is explained and given out. Especially this accelerometer will tell us more about the amount of mobilisation or immobilisation at home. The last follow-up will be 1 year after trauma. At all follow-ups radiological controls are performed. These will be conventional x-rays. Only in specific cases, for example prolonged pain, an CT-scan will be performed.

Data and data management. The sample size was based on the expected difference between treatment groups in improvement on the DEMMI score between baseline and 4 months follow-up. Previous studies show that the minimal clinical important difference of the DEMMI score is 10 points. This results in a sample size of 68 patients, accounted for 10% loss to follow-up.

The statistical planned analyses are primary a pearson chi-squared or fishers exact test for categorical variables or a students t or mann-whitney test. However the primary outcome will be analysed using mixed linear models with random effects. The models will be compared usin Akaike information criterium. Missing data will be imputed using multiple imputation. All analyses will be performed using SPSS version 19 or higher. A p value <0.05 is regarded as being statistically significant.

Data is stored on the protected server systems of Hospital of Lucerne. Files containing anonymous data can also be stored on the personal computers of the investigators. Data is recorded on paper and digitally. Questionnaires are on paper, but all the measurements, as the DEMMI score of range of motion will be digitally. Participants can not be identified in the CRF (Case report form). Appropriate corresponding codes are only known and accessible for the investigators.

Upon simple request by the patient, he or she will immediately be withdrawn from the study and no further date will be recorded in the study. It is guaranteed that further treatment will be equal to standard care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Informed Consent as documented by signature

• The fracture must be a fragility fracture. This means absence of high energy trauma.

• Fragility fracture of the sacrum (FFP II b + c). Involvement of the ventral pelvic ring is not an exclusion criteria.

• Able to walk 4 meters before fracture

Exclusion Criteria:

• Patients who had a high energy trauma.

• FFP I or FFP III+IV were operative therapy is recommended

• Patient who are not operable according to the anaesthesiologist on call.

• Open fractures.

• Revision surgeries.

• Absent contact information

• Living abroad and cannot participate in follow-up visits.

• Withdrawal from the study.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Pelvic Fracture

Intervention

Procedure:
• Treatment of FFP type IIb and IIc
Patients will either be randomized in the surgical or conservative group.

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Björn-Christian Link

Country where clinical trial is conducted

Switzerland, 

References & Publications (17)

de Morton NA, Davidson M, Keating JL. The de Morton Mobility Index (DEMMI): an essential health index for an ageing world. Health Qual Life Outcomes. 2008 Aug 19;6:63. doi: 10.1186/1477-7525-6-63. — View Citation

Fuchs T, Rottbeck U, Hofbauer V, Raschke M, Stange R. [Pelvic ring fractures in the elderly. Underestimated osteoporotic fracture]. Unfallchirurg. 2011 Aug;114(8):663-70. doi: 10.1007/s00113-011-2020-z. German. — View Citation

Hobart JC, Thompson AJ. The five item Barthel index. J Neurol Neurosurg Psychiatry. 2001 Aug;71(2):225-30. doi: 10.1136/jnnp.71.2.225. — View Citation

Hopf JC, Krieglstein CF, Muller LP, Koslowsky TC. Percutaneous iliosacral screw fixation after osteoporotic posterior ring fractures of the pelvis reduces pain significantly in elderly patients. Injury. 2015 Aug;46(8):1631-6. doi: 10.1016/j.injury.2015.04.036. Epub 2015 May 14. — View Citation

Konig A, Oberkircher L, Beeres FJP, Babst R, Ruchholtz S, Link BC. Cement augmentation of sacroiliac screws in fragility fractures of the pelvic ring-A synopsis and systematic review of the current literature. Injury. 2019 Aug;50(8):1411-1417. doi: 10.1016/j.injury.2019.06.025. Epub 2019 Jun 28. — View Citation

Konig MA, Hediger S, Schmitt JW, Jentzsch T, Sprengel K, Werner CML. In-screw cement augmentation for iliosacral screw fixation in posterior ring pathologies with insufficient bone stock. Eur J Trauma Emerg Surg. 2018 Apr;44(2):203-210. doi: 10.1007/s00068-016-0681-6. Epub 2016 May 11. — View Citation

Matta JM, Saucedo T. Internal fixation of pelvic ring fractures. Clin Orthop Relat Res. 1989 May;(242):83-97. — View Citation

Oberkircher L, Ruchholtz S, Rommens PM, Hofmann A, Bucking B, Kruger A. Osteoporotic Pelvic Fractures. Dtsch Arztebl Int. 2018 Feb 2;115(5):70-80. doi: 10.3238/arztebl.2018.0070. — View Citation

Richter PH, Gebhard F, Dehner C, Scola A. Accuracy of computer-assisted iliosacral screw placement using a hybrid operating room. Injury. 2016 Feb;47(2):402-7. doi: 10.1016/j.injury.2015.11.023. Epub 2015 Dec 12. — View Citation

Rommens PM, Hofmann A. Comprehensive classification of fragility fractures of the pelvic ring: Recommendations for surgical treatment. Injury. 2013 Dec;44(12):1733-44. doi: 10.1016/j.injury.2013.06.023. Epub 2013 Jul 18. — View Citation

Rommens PM, Wagner D, Hofmann A. [Osteoporotic fractures of the pelvic ring]. Z Orthop Unfall. 2012 Jun;150(3):e107-18; quiz e119-20. doi: 10.1055/s-0032-1314948. Epub 2012 Jun 21. German. — View Citation

Rommens PM, Wagner D, Hofmann A. Minimal Invasive Surgical Treatment of Fragility Fractures of the Pelvis. Chirurgia (Bucur). 2017 Sept-Oct;112(5):524-537. doi: 10.21614/chirurgia.112.5.524. — View Citation

Routt ML Jr, Simonian PT, Mills WJ. Iliosacral screw fixation: early complications of the percutaneous technique. J Orthop Trauma. 1997 Nov;11(8):584-9. doi: 10.1097/00005131-199711000-00007. — View Citation

Ruhle A, Oehme F, Link BC, Metzger J, Fischer H, Stickel M, Delagrammaticas DE, Babst R, Beeres FJP. Swiss chocolate and free beverages to increase the motivation for scientific work amongst residents: a prospective interventional study in a non-academic teaching hospital in Switzerland. Trials. 2020 Jan 13;21(1):74. doi: 10.1186/s13063-019-3956-5. — View Citation

Unnanuntana A, Laohaprasitiporn P, Jarusriwanna A. Effect of bisphosphonate initiation at week 2 versus week 12 on short-term functional recovery after femoral neck fracture: a randomized controlled trial. Arch Osteoporos. 2017 Dec;12(1):27. doi: 10.1007/s11657-017-0321-8. Epub 2017 Mar 10. — View Citation

Wagner D, Ossendorf C, Gruszka D, Hofmann A, Rommens PM. Fragility fractures of the sacrum: how to identify and when to treat surgically? Eur J Trauma Emerg Surg. 2015 Aug;41(4):349-62. doi: 10.1007/s00068-015-0530-z. Epub 2015 Apr 18. — View Citation

Wahnert D, Raschke MJ, Fuchs T. Cement augmentation of the navigated iliosacral screw in the treatment of insufficiency fractures of the sacrum: a new method using modified implants. Int Orthop. 2013 Jun;37(6):1147-50. doi: 10.1007/s00264-013-1875-8. Epub 2013 Apr 4. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility level	DEMMI (0-100, 100 is maximal mobility)	1 year
Secondary	Pain levels	VAS (visual analogue scale, 0-10, 0 means no pain)	1 year
Secondary	Clinical characteristics	Age	Baseline
Secondary	Clinical characteristics	Gender	Baseline
Secondary	Clinical characteristics	ASA-Score (1-6, 1 is a healthy patient)	Baseline
Secondary	Clinical characteristics	BMI	Baseline, 1 year
Secondary	Clinical characteristics	Osteoporosis treatment (yes or no)	Baseline
Secondary	Medication	Reporting what kind of medications all patients take (including steroids, anticoagulation, pain killers, et cetera)	Baseline, 1 year
Secondary	Clinical characteristics	Surgical related complications	Through study completion, an average of 1 year
Secondary	Clinical characteristics	Length of hospital stay after first admission	after discharge
Secondary	Clinical characteristics	Fracture classification (FFP I - IV)	Baseline
Secondary	Clinical characteristics	FES-1 (falls efficacy scale, 16-64, 16 means no fear of falling, 64 is the maximum)	1 year
Secondary	Clinical characteristics	EQ-5D (0-100, 100 is the best possible health status)	1 year
Secondary	Clinical characteristics	SPPB (short physical performance battery, 0-12, 12 is the best function)	1 year
Secondary	Mobility level	Barthel Index (0-100, 100 is completely independent)	1 year
Secondary	Mobility level	Accelerometer (this is a device that continously measures the activity level of an patient. It comes in the form of a bracelet)	During 1 week after 4 Months
Secondary	Mobility level	TUG (time up and go test)	1 year
Secondary	Mobility level	5 Chair rise	1 year