Clinical trial NCT01264172: Identification of Microcirculation and Inflammation After Minimal-invasive Osteosynthesis of the Proximal Femur
Official title: Identification of the Cutaneous and Muscular Microcirculation and Inflammatory Response After Minimal-invasive Osteosynthesis of the Proximal Femur
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Level of Pain
Keywords: Functional outcome
Microcirculation
Inflammatory response
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microcirculation
timeFrame: within 12 days
Secondary outcomes:
measure: Systemic inflammatory response
timeFrame: within 12 days
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universal Hospital of the RWTH Aachen University
state: NRW
Study officials:
affiliation: Chief of medicine
name: Hans-Christoph Pape, Univ-prof.MD
role: STUDY_CHAIR
References: