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Gait Analysis after Internal Fixation for a Femoral Neck Fracture.


- candidate number8275
- NTR NumberNTR2437
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jul-2010
- Secondary IDsNL32419.078.10  METC Rotterdam
- Public TitleGait Analysis after Internal Fixation for a Femoral Neck Fracture.
- Scientific TitleGait Analysis after Internal Fixation for a Femoral Neck Fracture.
- ACRONYM
- hypothesisPatients treated with Cancellous Screws (CS) for a femoral neck fracture will have a more asymmetrical gait pattern with more use of compensatory mechanisms than patients treated with a Sliding Hip Screw (SHS) >1 year after treatment.
- Healt Condition(s) or Problem(s) studiedFemoral fracture, Internal fixation
- Inclusion criteria1. Active participation in the FAITH trial (NL13205.078.06; NTR1151);
2. Obtained informed consent;
3. Patients are >1 year after initial surgical treatment for femoral neck fracture.
- Exclusion criteria1. 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);
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 (e.g. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2010
- planned closingdate1-sep-2011
- Target number of participants100
- InterventionsNone (patients were randomized in a previous trial between treatment with Cancellous Screws (CS) or a Sliding Hip screw (SHS) ).
- Primary outcomeAn analysis of the gait pattern, reflected by various parameters.
The parameters reflecting characteristics of the gait pattern that will be measured are:
In stance:
1. Static pressure distribution under the patientís feet (percentage of body weight);
2. Pronation and supination of the patientís feet (pressure distribution between medial vs. lateral foot regions).
During walking:
1. Walking velocity (cm/s);
2. Cadence (steps/min);
3. Step length and stride length (cm);
4. Stance time and ambulation time (ms);
5. Active propulsion time and passive propulsion time (ms);
6. Total contact area (cm2);
7. Vertical ground reaction forces vector (kg);
8. Rate of loading (kg/ms).
- Secondary outcome1. Femoral neck shortening (clinical assessment and radiologic assessment);
2. Incidence of applied correcting heel-lifts;
3. Height of applied correcting heel-lifts;
4. SF-12;
5. EQ-5D;
6. WOMAC;
7. Visual Analogue Scale for patient satisfaction.
- TimepointsOnce, >1 year after initial surgical treatment.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. S.M. Zielinski
- CONTACT for SCIENTIFIC QUERIESMD. S.M. Zielinski
- Sponsor/Initiator Erasmus MC, Trauma Research Unit department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Stichting Coolsingel
- PublicationsZielinski SM, Keijsers NL, Praet NFE, Heetveld MJ, Bhandari M, Wilssens JP, Patka P, Van Lieshout EMM, on behalf of the FAITH trial investigators. Femoral Neck Shortening After Internal Fixation of a Femoral Neck Fracture. Orthopedics 2013 Jul 1;36(7):e849-e858.

Zielinski SM, Keijsers NL, Praet SFE, Heetveld MJ, Bhandari M, Wilssens JP, Patka P, Van Lieshout EMM, on behalf of the FAITH trial investigators. Functional Outcome After Successful Internal Fixation Versus Salvage Arthroplasty of Patients With a Femoral Neck Fracture. J Orthop Trauma 2014 Dec;28(12):e273-e28.
- Brief summaryBackground:
The treatment of femoral neck fractures with internal fixation can lead to femoral neck shortening due to impaction at the fracture site upon axial loading during weight bearing. Femoral neck shortening may lead to significant physical function disorders, pain and an asymmetrical gait pattern. Reduced femoral neck shortening could therefore lead to better patient outcome post-surgery. The choice of implant, due to its characteristics, may have an effect on the amount of femoral neck shortening. The use of a sliding hip screw (SHS) may reduce the amount of femoral neck shortening when compared with cancellous screws (CS) from a biomechanical perspective. Incidence numbers of femoral neck shortening in recent studies support this suggestion. However, current evidence is inadequate.

Objectives:
Primary objective:
To assess the effect of implant choice (CS vs SHS) on gait pattern in patients that are >1 year after surgical treatment for a femoral neck fracture.
Secondary objectives:
1. To assess the effect of implant choice (CS vs SHS) on:
A. The incidence and extent of femoral neck shortening, and;
B. The rate of use of heel-lifts, in patients that are >1 year after surgical treatment for a femoral neck fracture.
2. To assess the effect of:
A. Femoral neck shortening (with or without use of compensatory heel-lift), and;
B. Implant removal on gait pattern, quality of life and patient satisfaction, in patients that are > 1 year after surgical treatment with internal fixation for a femoral neck fracture.

Study design:
Single-center comparative study in addition to a previous randomised controlled trial (with participation from patients from multiple hospitals).

Population:
Patients 50 years and older who were treated for a femoral neck fracture with internal fixation >1 year ago, and participated in the FAITH trial.

Primary outcome:
An analysis of the gait pattern, reflected by various parameters. The parameters reflecting characteristics of the gait pattern that will be measured are:
In stance:
1. Static pressure distribution under the patientís feet (percentage of body weight);
2. Pronation and supination of the patientís feet (pressure distribution between medial vs. lateral foot regions).
During walking:
1. Walking velocity (cm/s);
2. Cadence (steps/min);
3. Step length and stride length (cm);
4. Stance time and ambulation time (ms);
5. Active propulsion time and passive propulsion time (ms);
6. Total contact area (cm2);
7. Vertical ground reaction forces vector (kg);
8. Rate of loading (kg/ms).

Secondary outcome:
1. Femoral neck shortening (clinical assessment and radiologic assessment);
2. Incidence of applied correcting heel-lifts;
3. Height of applied correcting heel-lifts;
4. SF-12, EQ-5D and WOMAC;
5. Visual Analogue Scale for patient satisfaction (NB: X-rays, SF-12, EQ-5D and WOMAC are already available for all patients from their participation in the FAITH trial).

Patients will visit the hospital once for:
1. Measurement of limb length;
2. Completion of a short questionnaire (7 questions);
3. Measurement of maximum force of the hip joint;
4. Gait analysis.
- Main changes (audit trail)
- RECORD30-jul-2010 - 28-jan-2015


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