Gait Analysis after Internal Fixation for a Femoral Neck Fracture

Completed

Conditions: broken hip
Femoral neck fracture
10005942
10005944

Registration Number: NL-OMON36816

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 152

Inclusion Criteria

1. Active participation in the FAITH trial
2. Obtained informed consent
3. Patients are >1 year after initial surgical treatment for femoral neck fracture
4. Patients who had revision surgery (arthroplasty) (only applies to revision surgery/arthroplasty patients)

Exclusion Criteria

1. Primary surgery converted to arthroplasty (due to unsuccessful fracture reduction)
2. Revision surgery to the affected hip for any reason other than removal of the osteosynthesis material (e.g. due to avascular necrosis, non-union, or implant break-out) (does not apply to revision surgery/arthroplasty patients)
3. Previous internal fixation or arthroplasty of the contralateral (i.e., control) hip
4. Other lower limb abnormalities present that can be expected to influence gait pattern (i.e. other fractures present at the time of the study or a history of lower limb amputation)
5. Patient is not capable to walk several meters across the force measurement plate independently (with or without ambulatory aid)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>An analysis of the gait pattern, reflected by various parameters. The<br /><br>parameters reflecting characteristics of the gait pattern that will be measured<br /><br>are:<br /><br>In stance:<br /><br>- Static pressure distribution under the patients feet (percentage of body<br /><br>weight)<br /><br>- Pronation and supination of the patients feet (pressure distribution between<br /><br>medial vs. lateral foot regions)<br /><br><br /><br>During walking:<br /><br>- Walking velocity (cm/s)<br /><br>- Cadence (steps/min)<br /><br>- Step length and stride length (cm)<br /><br>- Stance time and ambulation time (ms)<br /><br>- Active propulsion time and passive propulsion time (ms)<br /><br>- Total contact area (cm2)<br /><br>- Vertical ground reaction forces vector (kg)<br /><br>- Rate of loading (kg/ms)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Femoral neck shortening (clinical assessment and radiologic assessment; not<br /><br>applicable for the revision surgery/arthroplasty patients)<br /><br>- Incidence of applied correcting heel-lifts<br /><br>- Height of applied correcting heel-lifts<br /><br>- SF-12<br /><br>- EQ-5D<br /><br>- WOMAC<br /><br>- Visual Analogue Scale for patient satisfaction<br /><br><br /><br>(NB: X-rays, SF-12, EQ-5D and WOMAC are already available for all patients from<br /><br>their participation in the FAITH trial).</p><br>