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Completed

NCT Number: NCT01264172

Identification of Microcirculation and Inflammation 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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universal Hospital of the RWTH Aachen University

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCCP

Procedure

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 names: percutaneous compression-plate

DHS

Procedure

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

Other names: Dynamic hip screw

Osteosynthesis with nails

Procedure

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

Primary outcomes

  1. Microcirculation

    Time frame: within 12 days

    The microcirculation is measured on different times by O2c to observe the trauma of surgery on skin and tissue and any wound healing difficulties.

Secondary outcomes

  1. Systemic inflammatory response

    Time frame: within 12 days

    The systemic inflammatory response is monitored by different inflammatory parameters in blood samples, which are taken on several occasions post-op

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Acronym: MicroProxFem

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 21, 2010
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.