Treatment of Pelvic Ring Fractures in the Elderly

NCT02590783 | Terminated

• 1 other identifier: 2015-188
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Pain

Keywords

treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Activities of Daily Living (ADL) at baseline

  baseline

• Activities of Daily Living (ADL) at 4-7 days after diagnosis

  4-7 days after diagnosis

• Activities of Daily Living (ADL) at 3 weeks

  3 weeks

• Activities of Daily Living (ADL) at 3 months

  3 months

• Activities of Daily Living (ADL) at 12 months

  12 months

Study Arms (2)

experimental intervention surgery

EXPERIMENTAL

screw osteosynthesis of the sacrum and in certain cases additional plate osteosynthesis of dislocated pubic rami fractures, postoperative analgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary

Procedure: experimental intervention surgery

control intervention conservative

ACTIVE COMPARATOR

analgesia, physiotherapy, work-up for osteoporosis, geriatric rehabilitation if necessary

Procedure: control intervention

Interventions

experimental intervention surgery PROCEDURE

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 Over the Kirschner-wires 7.0 mm cannulated screws are introduced and the Kirschner-wires withdrawn.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).

experimental intervention surgery

control intervention PROCEDURE

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.

control intervention conservative

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4021, 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: 23871193 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcel Jakob, Prof

  University Hospital, Basel, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 29, 2015
• Study Start: October 17, 2017
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CH (1)