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
  Purpose

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.


Condition Intervention
Level of Pain
Procedure: PCCP
Procedure: DHS
Procedure: Osteosynthesis with nails

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Identification of the Cutaneous and Muscular Microcirculation and Inflammatory Response After Minimal-invasive Osteosynthesis of the Proximal Femur

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 50
Study Start Date: December 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PCCP, Proximal femur fracture
Patients, who received a minimal-invasive surgical treatment with the PCCP-plate
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
Active Comparator: Osteosythesis with nails, prox. femur frac.
Patients, who received a minimal-invasive surgical treatment including a osteosynthesis with nails
Procedure: Osteosynthesis with nails
Osteosynthesis with nails is a minimal-invasive surgery technique for proximal femur fractures.
Active Comparator: DHS, proximal femur fracture
Patients, who received a conventional surgical treatment with the dynamic hip screw (DHS)
Procedure: DHS
Conventional surgical treatment of proximal femur fracture including one longer approach from lateral
Other Name: Dynamic hip screw

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264172

Locations
Germany
Universal Hospital of the RWTH Aachen University
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Study Chair: Hans-Christoph Pape, Univ-prof.MD Chief of medicine
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01264172     History of Changes
Other Study ID Numbers: CTC-A10-28
Study First Received: December 19, 2010
Last Updated: November 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
Functional outcome
Microcirculation
Inflammatory response

ClinicalTrials.gov processed this record on April 15, 2014