Trial document
This trial has been registered retrospectively.
DRKS00013275
Trial Description
Title
Retrospective analysis for treatment of proximal tibial fractures with a complete metaphyseal component in two centers with different distinct strategies: Open reduction and internal fixation (ORIF) and Ilizarov frame (Odense, Denmark) versus ORIF and locking plates (Freiburg, Germany)
Trial Acronym
ProTibExPla
URL of the Trial
[---]*
Brief Summary in Lay Language
The concurrent presence of a joint and a metaphyseal component is a typical biomechanical characteristic of proximal tibial fractures. Whereas the articular surface requires anatomical reduction and internal fixation providing absolute stability, the metaphysis is usually fixed with implants offering relative stability considering the local biological requirements. This can be done using external or internal fixation. The study aimes to compare both methods.
Brief Summary in Scientific Language
The concurrent presence of a joint and a metaphyseal component is a typical biomechanical characteristic of proximal tibial fractures. Whereas the articular surface requires anatomical reduction and internal fixation providing absolute stability, the metaphysis is usually fixed with implants offering relative stability considering the local biological requirements. Locking plates, which were introduced in the 90ies [1], allow an effective treatment addressing both parts. A more traditional approach is the combination of lag screws for joint reconstruction with an Ilizarov frame stabilizing the metaphysis. Clinical results were reported for both treatment standards [2, 3], however, comparing studies are lacking. Recently, a systematic review evaluated both principals based on the published cohort studies [4]. Although the paper makes a differentiated analysis available, there are obvious difficulties e.g. report the included studies only case series and do not compare, and inclusion criteria or outcome parameter do not match each other. Overall, the current literature is limited to an expert opinion level. In conclusion, there is a need for comparative studies. A major problem in orthopedic surgery is that the procedure under investigation needs to be carried out with a specific competence. Therefore, multicenter study designs with a ‘one arm – one center’ - design experienced a growing popularity, because they allow that a specific operation is performed repeatedly and with high quality in one of the participating hospitals [5]. As a first step, a retrospective evaluation of patients treated differently in two large hospitals of comparable competence, spectrum and size facilitates a direct comparison of tibial metaphyseal stabilization methods. Efficacy of bony consolidation is a suitable primary endpoint, because it is both important and well documented. Our hypothesis is that the treatment of proximal tibial fractures with a complete metaphyseal component is equally efficient comparing stabilization using an Ilizarov frame with locking plates.
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00013275
- 2017/11/10
- [---]*
- yes
- Approved
- 582/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
- U1111-1204-6367
Health Condition or Problem studied
- S82.1 - Fracture of upper end of tibia
Interventions/Observational Groups
- retrospective registration of proximal tibia fractures with complete metaphyseal component (Schatzker types V/VI, OTA/AO A2/3, C1-3) treated with Ilizarov frame
- retrospective registration of proximal tibia fractures with complete metaphyseal component (Schatzker types V/VI, OTA/AO A2/3, C1-3) treated with locking plates
Characteristics
- Non-interventional
- Observational study
- Non-randomized controlled trial
- Open (masking not used)
- [---]*
- Active control (effective treament of control group)
- Treatment
- Other
- N/A
- N/A
Primary Outcome
bony consolidation after 6 months evaluated by X-rays and clinical weight bearing
Secondary Outcome
complications
Countries of Recruitment
- Germany
- Denmark
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2017/07/18
- 200
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- 15 Years
- no maximum age
Additional Inclusion Criteria
Inclusion criteria were: patients with an AO 41 A2, A3 or C1-C3 fracture, who were treated either with external fixation using the Ilizarov wire frame or open reduction and internal fixation using locking plates between the 1. January 2009 and the 31. December 2015.
Exclusion Criteria
Exclusion criteria were: patients younger than 15 years of age at the time of the fracture or with open growth plates; patients with definitive operative fixation of the fracture more than 3 weeks after trauma; patients with pathological fractures (including osteoporotic fractures).
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinik Freiburg, Klinik für Orthopädie und Unfallchirurgie
- Mr. PD Kaywan Izadpanah
- Hugstetter Str. 55
- 79106 Freiburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49 761 270 24010
- [---]*
- kaywan.izadpanah at uniklinik-freiburg.de
- https://www.uniklinik-freiburg.de/de.html
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- University Hospital Odense, Department of Orthopaedics and Traumatology
- Mr. Prof. Hagen Schmal
- Sdr. Boulevard 29
- 5000 Odense C
- Denmark
end of 1:1-Block address otherstart of 1:1-Block address contact other- ß45 29428705
- [---]*
- hagen.schmal at rsyd.dk
- http://www.ouh.dk/wm373898
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Universitätsklinik Freiburg, Klinik für Orthopädie und Unfallchirurgie
- Mr. PD Kaywan Izadpanah
- Hugstetter Str. 55
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 761 270 24010
- [---]*
- kaywan.izadpanah at uniklinik-freiburg.de
- https://www.uniklinik-freiburg.de/de.html
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinik Freiburg, Klinik für Orthopädie und Unfallchirurgie
- Mr. PD Kaywan Izadpanah
- Hugstetter Str. 55
- 79106 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 761 270 24010
- [---]*
- kaywan.izadpanah at uniklinik-freiburg.de
- https://www.uniklinik-freiburg.de/de.html
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universitätsklinikum Freiburg
- Hugstetter Strasse 49
- 79095 Freiburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2017/09/30