Trial document
This trial has been registered retrospectively.
DRKS00013703
Trial Description
Title
Prospective Evaluation of Sacrum fractures in the Elderly
Trial Acronym
PRESS
URL of the Trial
Brief Summary in Lay Language
Patients over 60 years or under 60 years of age with osteopenia or osteoporosis and posterior pelvic ring fracture (sacrum) that is not grossly displaced are randomly divided into an operative and a conservative group after a low-energy trauma and the therapy success is compared. In total, the patients are followed for two years. The results are objectified by scientific questionnaires after 6 weeks, 6, 12 and 24 months regarding quality of life, pain, need for care and the ability to walk. The aim of the study is to determine the superiority of a therapeutic regime in terms of better quality of life, faster pain relief and/or less need for care.
Brief Summary in Scientific Language
Prospective randomized evaluation of the therapy (surgical versus conservative) of os sacrum insufficiency fractures in elderly patients (>60 or known osteoporosis/osteopenia). 65 patients per arm are planned, randomized 1-3 days after admission, the conservative group receives an opiod-supported analgesia and is immediately mobilized with pain-adapted full load. The operative arm receives a treatment of the fracture by transiliosacral screw osteosynthesis and external fixator from ventral or plate osteosynthesis of the pubic rami, also here a pain-adapted full load is allowed. Follow up: 2 years.
Organizational Data
- DRKS00013703
- 2018/12/10
- [---]*
- yes
- Approved
- PV5550, Ethik-Kommission der Ärztekammer Hamburg
Secondary IDs
- [---]*
Health Condition or Problem studied
- S32.1 - Fracture of sacrum
- S32.89 - [generalization S32.8: Fracture of other and unspecified parts of lumbar spine and pelvis]
Interventions/Observational Groups
-
Operative therapy within 1-3 days - Transiliosacral screw fixation with one or two cannulated 7.3mm screw(s) through the os ilium and the vertebral bodies of S1 and possibly of S2.
Simultaneous application of an external anterior pelvis fixateur externe for 6 weeks or an ORIF (open reduction and internal fixation) with an angle-stable plate of the pubic ossis.
Applies only to the operative arm:
Change from conservative to operative, if adequate mobilisation cannot be achieved after 5 days due to pain, the patient is transferred from conservative to surgical group. - Conservative therapy: analgesia with opioids (oxycodone 10mg 2x daily) and an NSAID or paracetamol. Immediate mobilization under full load of the affected side with the help of physiotherapists.
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Open (masking not used)
- [---]*
- Active control (effective treament of control group)
- Treatment
- Parallel
- N/A
- N/A
Primary Outcome
Mortality, pain intensity.
Scores of EQ5D, Tinetti-Gait and Barthel-Index after 6 weeks, after 6, 12 and 24 months.
Secondary Outcome
Morbidity and Quality of life.
Scores of VAS, EQ5D, Tinetti-Gait and Barthel-Index after 6 weeks, after 6, 12 and 24 months.
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2018/01/18
- 130
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 60 Years
- no maximum age
Additional Inclusion Criteria
All patients who have a B2.1 posterior pelvic ring fracture after low-energy trauma AND are 60 years and older OR younger than 60 years and also suffering from osteporosis/osteopenia.
Exclusion Criteria
Younger than 60 and no osteoporosis.
Unclear whether fresh or old injury.
Accident longer than 2 weeks ago.
High energy Trauma.
Addresses
-
start of 1:1-Block address primary-sponsor
- UKE Hamburg EppendorfUnfall-, Hand- und Wiederherstellungschirurgie
- Mr. Dr. med. Darius Thiesen
- Martinistr. 52
- 20246 Hamburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +4940741018014
- [---]*
- d.thiesen at uke.de
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- UKE Hamburg EppendorfUnfall-, Hand- und Wiederherstellungschirurgie
- Mr. Dr. med. Darius Thiesen
- Martinistr. 52
- 20246 Hamburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +4940741018014
- [---]*
- d.thiesen at uke.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- UKE Hamburg EppendorfUnfall-, Hand- und Wiederherstellungschirurgie
- Mr. Dr. med. Darius Thiesen
- Martinistr. 52
- 20246 Hamburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +4940741018014
- [---]*
- d.thiesen at uke.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- ZOM, Unfall-, Hand- und Rekonstruktive Chirurgie
- UKE Uniklinikum Hamburg Eppendorf
- Martinistraße 52
- 20246 Hamburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 040 74100
- 040 74100
- d.thiesen at uke.de
- http://www.uke.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
Trial Publications, Results and other Documents
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