NCT02591043

Brief Summary

Since May 2010 the Department of Trauma, Basel University Hospital has performed surgical stabilisation of the posterior pelvic ring on 55 patients. These patients have not received a structured follow up examination or evaluation of outcome after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

October 8, 2015

Last Update Submit

September 28, 2016

Conditions

Fracture

Keywords

PelvicTreatment Outcome

Outcome Measures

Primary Outcomes (1)

  • TUG-Test through study completion, an average of 1 year

    TUG test - according test description

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • activity of daily living (ADL) through study completion, an average of 1 year

    through study completion, an average of 1 year

  • Pain test through study completion, an average of 1 year

    through study completion, an average of 1 year

  • Living Situation through study completion, an average of 1 year

    through study completion, an average of 1 year

  • 1-year mortality

    one year after surgery

Study Arms (1)

Follow-up

OTHER

Patients have not received a structured follow up examination or evaluation of outcome after surgery. Therefore this study aims at conducting a follow up examination regarding functional outcome, pain and radiologic healing in these patients.

Procedure: Outcome after surgery

Interventions

Outcome after surgeryPROCEDURE

Functional outcome after surgical treatment of pelvic ring fractures Measurements: TUG-test score, ADLs index, maximal pain (VAS 1-10) at rest and experienced during TUG-test. One-year mortality, signs of healing, dislocation or other complications on anterior-posterior radiographs of the pelvis, living situation before and after the injury (at home/institutional placement)

Follow-up

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly patients (age ≥55y ears) of any ethnic / sociodemographic background
  • Pelvic ring fracture after low energy trauma affecting the posterior ring or both (posterior and anterior ring)
  • Surgical stabilisation of the pelvic ring at Basel University Hospital between May 2010 and December 2014
  • Ambulatory before surgery
  • Informed consent for study participation by the patient or legal representatives

You may not qualify if:

  • Refusal of consent by the patient or legal representatives to participate in the study
  • Fractures within the last 3 months before follow-up
  • Suspicion of a pathological fracture in the context of known or unknown malignancy
  • Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc.
  • Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient in a wheel chair)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Rebecca Hasler, Dr

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 29, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

CH(1)