Hip FracturesNCT04311892
Hip Abductor Muscle Dysfunction After Nailing of Proximal Femoral Fractures, Incidence and Contributing Factors.
An observational study of Hip Fractures, run by South Valley University at 1 site in Egypt.
Trial summary
Proximal femoral fractures(PFFs) are common with advancing age. Proximal femoral nail (PFN) is now increasingly used to fix unstable fractures. Studies have demonstrated that muscle strength deficit is significantly large after PFFs. N. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures
- What is being tested?
- EMG of the hip abductor muscles
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2019to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all patients (male or females) treated in our hospital for fracture of the proximal femur with or without obvious abductor lurch
Who may be able to join
- patients treated with this type of implant for proximal femoral fracture with or without abductor lurch, follow up more than 6 months, fracture full union
Who cannot join
- patients suffering from neurological disorder affecting the same side of surgery (polio- hemiplegia), less than 6 months follow up, fracture non- or delayed union, polytraumatized patients, pathological fractures
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Qena university hospital, South Valley University
Qina, Qena Governorate, 83523
Ahmed A Khalifa, 00201224466151
About this study
Proximal femoral fractures(PFFs) are common with advancing age. Proximal femoral nail (PFN) is now increasingly used to fix unstable fractures. Studies have demonstrated that muscle strength deficit is significantly large after PFFs. N. Ivanova et al found that hip muscle isometric strength for the fractured leg was significantly decreased 1 week and 6 months postoperatively. Besides, a recent study done by Nitin Wale et al concluded that abductor weakness and trendeleburg gait are fairly common in patients treated with PFN and this complaint is often overlooked. Despite significant improvement in muscle function after at least 6 months of physiotherapy as demonstrated by previous studies, we didn't come over a study explaining the main causes of remaining abductor lurch in patients with united fracture of the proximal femur treated using proximal femoral nail (short type).
Read the detailed description
In a group of patients treated at our hospital for fracture of the proximal femur using different generations of the proximal femoral nail and after full fracture union, although they had an excellent hip function we noticed that the majority of the patients still suffering from limping and abductor lurch with a Trendelenburg gait.
Purpose: to detect hip abductor muscle dysfunction after treating proximal femoral fracture using a proximal femoral nail (short type)
Research Questions: what is the reason(s) for remaining abductor lurch in patients with proximal femoral fracture treated with PFN?
Study Design: an observational retrospective
Study Group number: 20 patients (to be modified according to the number of patients registered at the study setting)
Assessment: (will be measured on both operated and non-operated sides)
- Clinical:
- Harris hip score.
- Leg length discrepancy: measured as the true length from the ASIS to the medial malleolus.
- The bulk of the abductor musculature: measured as the distance between the ASIS anteriorly and the ischial tuberosity posteriorly.
- Trendelenburg gait: assessed using modified McKay criteria2. These criteria measure pain symptoms, gait pattern, Trendelenburg sign status, and the range of hip joint movement
- Radiological:
- Fracture union: assessed using Apley and Solomon's criteria6. Complete bone union according to these criteria is defined as the time at which there is no pain upon local palpation, no swelling in the limb, ability to walk without support and pain-free, and evidence of a radiographic bridging callus or trabecula between fragments.
- Neck shaft angle: as the angle between the neck axis and the anatomical axis of the proximal femur.
- Leg length discrepancy: as the distance between a fixed reference point on the lesser trochanter on both sides and the trans-ischial line.
- Amount of nail prominent from the greater trochanter.
- Hip horizontal offset: the length of a line drawn from the centre of the femoral head and perpendicular to the anatomical axis of the femur.
- Neurophysiological:
EMG will be carried out to examine the (superior gluteal nerve) SGN for all patients. The EMGs will be performed by the same neurophysiologist. The muscles will be evaluated according to the criteria of the American Academy of Electrophysiological Medicine for needle EMG. In order to exclude patients with polyneuropathy, radiculopathy, or plexopathy, nerve conduction studies of both lower extremities will be performed. Then, gluteus medius muscles will be assessed bilaterally to evaluate the SGN, the vastus medialis muscle for L4 root, tibialis anterior muscle for L5 root, and gastrocnemius muscle for S1 root. First, resting activities will be assessed for the signs of acute denervation (fibrillation and positive sharp waves), followed by observation of the recruitment pattern examination of the motor unit action potential (MUAP) amplitudes, and time characteristics. Finally, motor patterns of interferences will be investigated during muscle contractions to obtain information about denervation and reinnervation of examined muscles
Outcomes to be measured:
- Primary outcome: Neurophysiological status of Hip abductors function (EMG)
- Secondary outcome: HHS, altered radiological hip biomechanics
- Conditions
- Hip Fractures
- Being tested
- EMG of the hip abductor muscles
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG of the hip abductor musclesDiagnostic test
EMG will be carried out to examine the (superior gluteal nerve) SGN for all patients. The muscles will be evaluated according to the criteria of the American Academy of Electrophysiological Medicine for needle EMG. In order to exclude patients with polyneuropathy, radiculopathy, or plexopathy, nerve conduction studies of both lower extremities will be performed. Then, gluteus medius muscles will be assessed bilaterally to evaluate the SGN, the vastus medialis muscle for L4 root, tibialis anterior muscle for L5 root, and gastrocnemius muscle for S1 root.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip abductor muscles neuro-physiological state
the state of the hip abductor muscles regarding it innervation and the state of the muscle fibers itself
Measured: 4 months
Secondary outcomes (1)
proximal femoral shortening
shortening of the treated side measured on the AP radiograph
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start18 Jan 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Adel Khalifa, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311892
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2020
- First submitted
- 14 Jan 2019
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Abductor Muscle Dysfunction After Nailing of Proximal Femoral Fractures, Incidence and Contributing Factors.
- ClinicalTrials.gov ID
- NCT04311892
- Acronym / sponsor ID
- 1
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proximal femoral fractures(PFFs) are common with advancing age. Proximal femoral nail (PFN) is now increasingly used to fix unstable fractures. Studies have demonstrated that muscle strength deficit is significantly large after PFFs. N. Ivanova et al found that hip muscle isometric strength for the fractured leg was significantly decreased 1 week and 6 months postoperatively. Besides, a recent study done by Nitin Wale et al concluded that abductor weakness and trendeleburg gait are fairly common in patients treated with PFN and this complaint is often overlooked. Despite significant improvement in muscle function after at least 6 months of physiotherapy as demonstrated by previous studies, we didn't come over a study explaining the main causes of remaining abductor lurch in patients with united fracture of the proximal femur treated using proximal femoral nail (short type).
Detailed description
In a group of patients treated at our hospital for fracture of the proximal femur using different generations of the proximal femoral nail and after full fracture union, although they had an excellent hip function we noticed that the majority of the patients still suffering from limping and abductor lurch with a Trendelenburg gait.
Purpose: to detect hip abductor muscle dysfunction after treating proximal femoral fracture using a proximal femoral nail (short type)
Research Questions: what is the reason(s) for remaining abductor lurch in patients with proximal femoral fracture treated with PFN?
Study Design: an observational retrospective
Study Group number: 20 patients (to be modified according to the number of patients registered at the study setting)
Assessment: (will be measured on both operated and non-operated sides)
- Clinical:
- Harris hip score.
- Leg length discrepancy: measured as the true length from the ASIS to the medial malleolus.
- The bulk of the abductor musculature: measured as the distance between the ASIS anteriorly and the ischial tuberosity posteriorly.
- Trendelenburg gait: assessed using modified McKay criteria2. These criteria measure pain symptoms, gait pattern, Trendelenburg sign status, and the range of hip joint movement
- Radiological:
- Fracture union: assessed using Apley and Solomon's criteria6. Complete bone union according to these criteria is defined as the time at which there is no pain upon local palpation, no swelling in the limb, ability to walk without support and pain-free, and evidence of a radiographic bridging callus or trabecula between fragments.
- Neck shaft angle: as the angle between the neck axis and the anatomical axis of the proximal femur.
- Leg length discrepancy: as the distance between a fixed reference point on the lesser trochanter on both sides and the trans-ischial line.
- Amount of nail prominent from the greater trochanter.
- Hip horizontal offset: the length of a line drawn from the centre of the femoral head and perpendicular to the anatomical axis of the femur.
- Neurophysiological:
EMG will be carried out to examine the (superior gluteal nerve) SGN for all patients. The EMGs will be performed by the same neurophysiologist. The muscles will be evaluated according to the criteria of the American Academy of Electrophysiological Medicine for needle EMG. In order to exclude patients with polyneuropathy, radiculopathy, or plexopathy, nerve conduction studies of both lower extremities will be performed. Then, gluteus medius muscles will be assessed bilaterally to evaluate the SGN, the vastus medialis muscle for L4 root, tibialis anterior muscle for L5 root, and gastrocnemius muscle for S1 root. First, resting activities will be assessed for the signs of acute denervation (fibrillation and positive sharp waves), followed by observation of the recruitment pattern examination of the motor unit action potential (MUAP) amplitudes, and time characteristics. Finally, motor patterns of interferences will be investigated during muscle contractions to obtain information about denervation and reinnervation of examined muscles
Outcomes to be measured:
- Primary outcome: Neurophysiological status of Hip abductors function (EMG)
- Secondary outcome: HHS, altered radiological hip biomechanics
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients (male or females) treated in our hospital for fracture of the proximal femur with or without obvious abductor lurch
Key inclusion criteria (1 listed)
- patients treated with this type of implant for proximal femoral fracture with or without abductor lurch, follow up more than 6 months, fracture full union
Key exclusion criteria (1 listed)
- patients suffering from neurological disorder affecting the same side of surgery (polio- hemiplegia), less than 6 months follow up, fracture non- or delayed union, polytraumatized patients, pathological fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG of the hip abductor musclesEMG will be carried out to examine the (superior gluteal nerve) SGN for all patients. The muscles will be evaluated according to the criteria of the American Academy of Electrophysiological Medicine for needle EMG. In order to exclude patients with polyneuropathy, radiculopathy, or plexopathy, nerve conduction studies of both lower extremities will be performed. Then, gluteus medius muscles will be assessed bilaterally to evaluate the SGN, the vastus medialis muscle for L4 root, tibialis anterior muscle for L5 root, and gastrocnemius muscle for S1 root. | Diagnostic test | – |
Primary outcome
Hip abductor muscles neuro-physiological state
Time frame: 4 months
the state of the hip abductor muscles regarding it innervation and the state of the muscle fibers itself
1 secondary outcome
proximal femoral shortening
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Khalifa, MD, FRCS (00201224466151, ahmed_adel0391@med.svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip abductor muscles neuro-physiological state (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.