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Identification of Microcirculation and Inflammation After Minimal-invasive Osteosynthesis of the Proximal Femur

Identification of the Cutaneous and Muscular Microcirculation and Inflammatory Response After Minimal-invasive Osteosynthesis of the Proximal Femur

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01264172
Acronym
MicroProxFem
Enrollment
50
Registered
2010-12-21
Start date
2010-12-31
Completion date
2012-11-30
Last updated
2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Level of Pain

Keywords

Functional outcome, Microcirculation, Inflammatory response

Brief summary

This project investigate any difference in inflammatory response,wound heeling rate, functional outcome and level of pain in patience with different surgical treatment (PCCT vs. DHS vs. Osteosynthesis with nails) after a fracture of the proximal femur.

Detailed description

This project investigates microcirculation in skin and muscle after different surgical treatment of pertrochanteric fractures of the femur for detecting the less damaging method. Three different systems are compared: the PCCT and the osteosynthesis with nails ( two minimal-invasive methods) and the conventional dynamic hip screw ( DHS). All three are long established and show no difference in results in any clinical trials. The method for every patient is chosen randomly. The microcirculation is measured as parameter for tissue damage and wound heeling. It is registered by O2c, which works with measuring reflected lightwaves. It is strictly noninvasive and causes absolutely no pain for the patient. The measurement device consists of two small probes, which simply stick to the patient´s skin. There are eleven measurements on this study: one directly before and one shortly after and one 6 h after the surgery, followed by three measuring appointments after 12, 24, 48 hours. Afterwards there are appointments planed after 4, 7 and 12 days. After 7 days a CT controls the leg-rotation. In addition it detects any dislocation of the fracture or fixing item.The next appointments are planed after 6 week. In the last two sessions the patients are questioned according to established questionnaires, e.g the Harris hip score to evaluate any loss of functionality of the operated leg. And a control of physical strength is planed on these appointments. It is known today that most patients can not reach the same level of physical strength after the treatment as before the fracture. Additionally an EMG records muscle damage. And the level of pain is evaluated with the Visual Analogue Scale simultaneity with the O2c-measurements. The last measurement is planed after 6 month. Then the fracture is controlled by an X-ray. Clinical parameters like operation time, blood loss, ASA score (for pre-existing condition) are included to create comparable patient profiles. Therefore the AO classification of the fracture and the grade of osteoporosis according to the Singh-Classification is recorded, too. Also on every measuring appointment blood samples are tested on parameters of systemic inflammatory response and muscle cell destruction. Furthermore this project is meant to establish limits of microcirculation measured with O2c. So in the future is will be possible to predict any wound heeling difficulties with this no-invasive measuring technic. Therefore this study will research on the one hand if these three operation methods differ in wound heeling, functionality or level of pain and on the other hand establish a possibility to detect wound heeling complications early and easily. Both results are extremely relevant to be able to choose the treatment most suited to the individual patient. So the pertrochanteric fracture of the femur, which is common in older and multimorbid population, will no longer result in risky re-operations due to wound heeling complications or limited functionality and quality of life.

Interventions

PROCEDUREPCCP

PCCP: an minimal-invasive surgery technique, in wich a special plate is pushed in position and fixed through 2 small approaches only (about 2 cm long)

PROCEDUREDHS

Conventional surgical treatment of proximal femur fracture including one longer approach from lateral

PROCEDUREOsteosynthesis with nails

Osteosynthesis with nails is a minimal-invasive surgery technique for proximal femur fractures.

Sponsors

RWTH Aachen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Above 60 years of age * Letter of approval firmed * Proximal femur fracture

Exclusion criteria

* Pathologic fracture * History of metabolic bone disease * Earlier surgery s of the hip or femur on the same leg * Fractures with osteosynthesis material of earlier treatment still in place * Soft tissue damage * Delay of surgery for more than 3 days * Immune default * Polytrauma * Fracture ends more than 5 cm distal of trochanter minor

Design outcomes

Primary

MeasureTime frameDescription
Microcirculationwithin 12 daysThe microcirculation is measured on different times by O2c to observe the trauma of surgery on skin and tissue and any wound healing difficulties.

Secondary

MeasureTime frameDescription
Systemic inflammatory responsewithin 12 daysThe systemic inflammatory response is monitored by different inflammatory parameters in blood samples, which are taken on several occasions post-op

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026