NCT04744350

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

December 10, 2020

Last Update Submit

October 2, 2023

Conditions

Pelvic Fracture

Outcome Measures

Primary Outcomes (1)

  • Mobility level

    DEMMI (0-100, 100 is maximal mobility)

    1 year

Secondary Outcomes (17)

  • Pain levels

    1 year

  • Clinical characteristics

    Baseline

  • Clinical characteristics

    Baseline

  • Clinical characteristics

    Baseline

  • Clinical characteristics

    Baseline, 1 year

  • +12 more secondary outcomes

Study Arms (2)

Surgical

ACTIVE COMPARATOR

Surgical treatment using a minimal invasive surgical method. At our hospital we perform a percutaneous sacroiliac osteosynthesis using cannulated, perforated and fenestrated screws. This procedure is preferably performed in our hybrid operation theatre, which allows for correct placement using an intraoperative CT-scan.

Procedure: Treatment of FFP type IIb and IIc

Conservative

ACTIVE COMPARATOR

Patients will receive individually tailored physiotherapy and analgesics if necessary.

Procedure: Treatment of FFP type IIb and IIc

Interventions

Treatment of FFP type IIb and IIcPROCEDURE

Patients will either be randomized in the surgical or conservative group.

ConservativeSurgical

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent as documented by signature
  • The fracture must be a fragility fracture. This means absence of high energy trauma.

You may not qualify if:

  • Able to walk 4 meters before fracture
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

RECRUITING

Related Publications (18)

  • 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.

    PMID: 29439771BACKGROUND

  • 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.

    PMID: 21800137BACKGROUND

  • 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.

    PMID: 22723074BACKGROUND

  • 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.

    PMID: 23871193BACKGROUND

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

    PMID: 2706863BACKGROUND

  • 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.

    PMID: 29088552BACKGROUND

  • 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.

    PMID: 26708797BACKGROUND

  • 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.

    PMID: 23553117BACKGROUND

  • 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.

    PMID: 9415865BACKGROUND

  • 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.

    PMID: 27167237BACKGROUND

  • 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.

    PMID: 26038048BACKGROUND

  • 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.

    PMID: 26052052BACKGROUND

  • 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.

    PMID: 31301810BACKGROUND

  • 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.

    PMID: 11459898BACKGROUND

  • 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.

    PMID: 18713451BACKGROUND

  • 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.

    PMID: 31931852BACKGROUND

  • 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.

    PMID: 28283937BACKGROUND

  • Haveman RA, van de Wall BJM, Rohner M, Beeres FJP, Haefeli PC, Baumgartner R, Babst R, Link BC. Conservative or operative therapy in patients with a fragility fracture of the pelvis: study protocol for a prospective, randomized controlled trial. Trials. 2024 Jul 30;25(1):513. doi: 10.1186/s13063-024-08350-z.

    PMID: 39080698DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Central Study Contacts

Roemalie Haveman

CONTACT

0041 79 618 9774Roemaliehaveman@gmail.com

B.C. Link, PD Dr. med.

CONTACT

0041 41 205 4820bjoern-christian.link@luks.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-director of the orthopaedics and traumatology department

Study Record Dates

First Submitted

December 10, 2020

First Posted

February 8, 2021

Study Start

November 1, 2022

Primary Completion

December 30, 2024

Study Completion

December 30, 2025

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)