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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02591043
Other study ID # 2015-299
Secondary ID
Status Completed
Phase N/A
First received October 8, 2015
Last updated September 28, 2016
Start date October 2015
Est. completion date September 2016

Study information

Verified date September 2016
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


Description:

Functional outcome of elderly patients with surgical treatment of low energy pelvic ring fractures.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Procedure:
Outcome after surgery
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)

Locations

Country Name City State
Switzerland University Hospital Basel Basel Basel-Stadt

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary TUG-Test through study completion, an average of 1 year TUG test - according test description through study completion, an average of 1 year No
Secondary activity of daily living (ADL) through study completion, an average of 1 year ADL test - according test description through study completion, an average of 1 year No
Secondary Pain test through study completion, an average of 1 year Maximal pain (VAS 1-10) experienced during TUG-test and at rest at the day of follow up through study completion, an average of 1 year No
Secondary Living Situation through study completion, an average of 1 year Living situation before and after the injury (at home/institutional placement) according test procedure through study completion, an average of 1 year No
Secondary 1-year mortality one year after surgery No
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