Treatment of Pelvic Ring Fractures in the Elderly

Pelvic Pain Clinical Trial

Official title:

Treatment of Pelvic Ring Fractures in the Elderly: A Randomized Controlled Trial Comparing Surgical vs. Conservative Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02590783
• Other study ID #: 2015-188
• Status: Terminated
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: July 11, 2022

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pelvic ring fractures in the elderly are associated with high morbidity during standard conservative treatment due to immobility. Furthermore the risk of long term dependence even after the fracture has united is high. In analogy to the treatment of hip fractures in a similar patient population, patients might benefit from surgical treatment due to a reduction in pain and early mobilization.

Description:

Comparison of surgical vs conservative treatment with respect to mobility, pain, morbidity and mortality.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: July 11, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• CTI/MRI verified fracture of the sacrum affecting the posterior ring or both posterior and anterior ring

• age>65 years, ambulatory with/without walking aids before Trauma

• ambulatory with/without walking aids before trauma

• postmenopausal status in women

• informed consent for study participation and surgery

Exclusion Criteria:

• Refusal of consent by the patient or legal representatives to participate in the study

• Other fractures or

• Unstable pelvic fracture (type B or C according to classification of 'Arbeitsgemeinschaft für Osteosynthesefragen' (AO)/OTA) requiring surgical stabilisation after high- or low-energy trauma

• Suspicion of a pathological fracture in the context of known or unknown malignancy

• Previous surgery of the pelvis with metal obstructing the planned paths of the ilio-sacral screws

• Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc.

• Comorbidity that precludes undergoing general or spinal anaesthesia

• 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 being in a wheel chair)

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

Procedure:
• experimental intervention surgery
Patients are placed supine on the carbon table. Screw paths are planned on a spiral CT scan from the sacrum on transversal slices, two Kirschner-wires 2.5 mm in diameter are introduced into the iliac bone through a stab incision and advanced into the ilio-sacral joint, through the lateral part of sacrum into the first and second sacral body, through the contralateral lateral part of the sacrum and exiting the contralateral iliac bone through the sacra-iliac joint with aid of CT-guidance. Over the Kirschner-wires 7.0 mm cannulated screws are introduced and the Kirschner-wires withdrawn. Several low-dose computer tomography scans are performed to secure the correct position. Total radiation dose is 300 mille gray square centimetres (mGycm).
• control intervention
Mobilization guided by our physiotherapists. Full weight bearing is allowed. Analgetic treatment with metamizol, ibuprofen or paracetamol to the attending physicians discretion under regular surveillance laboratory values and/ or morphine or methadone. Patients will be treated with an individually based approach, if necessary involving our anesthesiologic pain service. Thrombo-embolic prophylaxis with a low molecular weight heparin or rivaroxaban for 6 weeks unless there is an indication for oral anticoagulation. All patients will be followed up by the Geriatric Fracture Center considering osteoporosis, fall prophylaxis, malnutrition and delirium. For the duration of the study the patients will not receive Parathyroid Hormone Substitution or Phosphonates.

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	Mobility at 3 weeks post-diagnosis	Quality of mobilization will be compared using the TUG test. The primary endpoint is TUG at 3 weeks following diagnosis (+/- 3 days) all TUG measurements are assessed by the study nurse.	3 weeks post-diagnosis
Secondary	Activities of Daily Living (ADL) at baseline	Functional recovery will be measured using the ADL score.	baseline
Secondary	Activities of Daily Living (ADL) at 4-7 days after diagnosis	Functional recovery will be measured using the ADL score.	4-7 days after diagnosis
Secondary	Activities of Daily Living (ADL) at 3 weeks	Functional recovery will be measured using the ADL score.	3 weeks
Secondary	Activities of Daily Living (ADL) at 3 months	Functional recovery will be measured using the ADL score.	3 months
Secondary	Activities of Daily Living (ADL) at 12 months	Functional recovery will be measured using the ADL score.	12 months
Secondary	Pain (VAS 10) at baseline	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).	baseline
Secondary	Pain (VAS 10) at 4-7 days after diagnosis	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).	4-7 days after diagnosis
Secondary	Pain (VAS 10) at 3 weeks	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).	3 weeks
Secondary	Pain (VAS 10) at 3 months	Pain will be assessed using the 10 point Visual Analogue Scale (VAS10).	3 months
Secondary	Number of patients that are able to return to their pre-injury living situation at 3 months	Number of patients that are able to return to their pre-injury living Situation. The outcome to compare the "return to the pre-injury living situation".	3 months
Secondary	Number of patients that are able to return to their pre-injury living situation at 12 months	Number of patients that are able to return to their pre-injury living Situation. The outcome to compare the "return to the pre-injury living situation".	12 months