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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01264172
First received: December 19, 2010
Last updated: November 26, 2012
Last verified: November 2012

December 19, 2010
November 26, 2012
December 2010
November 2012   (final data collection date for primary outcome measure)
Microcirculation [ Time Frame: within 12 days ] [ Designated as safety issue: No ]
The microcirculation is measured on different times by O2c to observe the trauma of surgery on skin and tissue and any wound healing difficulties.
Same as current
Complete list of historical versions of study NCT01264172 on ClinicalTrials.gov Archive Site
Systemic inflammatory response [ Time Frame: within 12 days ] [ Designated as safety issue: No ]
The systemic inflammatory response is monitored by different inflammatory parameters in blood samples, which are taken on several occasions post-op
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Level of Pain
  • Procedure: PCCP
    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)
    Other Name: percutaneous compression-plate
  • Procedure: DHS
    Conventional surgical treatment of proximal femur fracture including one longer approach from lateral
    Other Name: Dynamic hip screw
  • Procedure: Osteosynthesis with nails
    Osteosynthesis with nails is a minimal-invasive surgery technique for proximal femur fractures.
  • Active Comparator: PCCP, Proximal femur fracture
    Patients, who received a minimal-invasive surgical treatment with the PCCP-plate
    Intervention: Procedure: PCCP
  • Active Comparator: Osteosythesis with nails, prox. femur frac.
    Patients, who received a minimal-invasive surgical treatment including a osteosynthesis with nails
    Intervention: Procedure: Osteosynthesis with nails
  • Active Comparator: DHS, proximal femur fracture
    Patients, who received a conventional surgical treatment with the dynamic hip screw (DHS)
    Intervention: Procedure: DHS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01264172
CTC-A10-28
No
RWTH Aachen University
RWTH Aachen University
Not Provided
Study Chair: Hans-Christoph Pape, Univ-prof.MD Chief of medicine
RWTH Aachen University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP