Health TrialsbyHealthPanel

Bone Marrow Injection in Fracture of Femoral Neck

ConditionsBone MarrowFemoral Neck Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorYaser Alkanash

About this trial

Objectives:

* Primary objective : * To investigate the predisposing factors for femoral neck fractures, including age, sex, and associated comorbidities. * To investigate the complications associated with intracapsular femoral neck fractures, particularly in young patients. * To evaluate the effectiveness of autologous bone marrow injection at the femoral neck fracture site and its effect on: * Achieving complete fracture union. * Reducing the time required for fracture healing. * Reducing the incidence of avascular necrosis of the femoral head. * Secondary objective:

The study addresses the challenge of performing total hip arthroplasty in young patients. Complications following intracapsular femoral neck fractures, particularly avascular necrosis and nonunion, may ultimately necessitate this treatment option. However, total hip arthroplasty is generally less desirable in young patients because of:

* Early prosthetic loosening. * The potential need for revision arthroplasty later in life due to wear and deterioration of prosthetic components over time. * Higher complication rates and lower long-term success rates. In this study, we will focus on the use of fully threaded cannulated screws combined with bone marrow injection into the fracture site, and evaluate their effect on the healing and union of intracapsular femoral neck fractures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 55 years.

Intracapsular femoral neck fracture classified as Garden type III or IV.

The time elapsed since the fracture occurred must not exceed 24 hours

Disqualifiers

Age under 18 years or over 55 years.

Open femoral neck fracture.

Neglected femoral neck fractures or fractures that occurred more than 24 hours prior to presentation.

Polytrauma patients who are in shock or admitted to the intensive care unit (ICU).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anatomical reduction and fixation with bone marrow injection

    Procedure/Surgery

    Anatomical reduction of the fracture will be achieved under fluoroscopic guidance, followed by fixation through a lateral surgical approach to the hip using three fully threaded cancellous screws with using bone marrow injection

  • Anatomical reduction with Fixation

    Procedure/Surgery

    Anatomical reduction of the fracture will be achieved under fluoroscopic guidance, followed by fixation through a lateral surgical approach to the hip using three fully threaded cancellous screws.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Group A:fixation using three fully threaded cancellousActive comparator 1 intervention
Group B: Group B: Fixation using three fully cancellous screws with injection of autologous bone marrowExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Fracture Union

Fracture union will be assessed using clinical and radiological criteria. Radiological healing will be evaluated on plain radiographs based on the formation of bridging callus across the fracture site and progressive disappearance of the fracture line. Clinical healing will be assessed based on the patient's clinical progress and ability to move the affected limb. Fracture status will be recorded as union or nonunion.

Time frame
6 months postoperatively.
2

Time to Fracture Union

The time required to achieve fracture union will be recorded from the date of surgery until the first clinical and radiological evidence of complete fracture union. Unit of Measure: Months

Time frame
Time Frame: Up to 6 months ]
3

. Avascular Necrosis of the Femoral Head

The incidence of avascular necrosis of the femoral head will be assessed by plain radiographs during follow-up. The presence or absence of radiographic evidence of avascular necrosis will be recorded. Unit of Measure: Participants with avascular necrosis (number and percentage)

Time frame
[Time Frame: 6 months postoperatively.]

Secondary outcomes

1

Harris Hip Score (HHS)

Clinical and functional outcomes will be assessed using the Harris Hip Score (HHS), a standardized numerical scoring system used to evaluate hip function following surgical intervention. The HHS includes assessment of pain, gait abnormalities (limp), functional activities, and range of motion of the hip joint. Pain and functional status will therefore be evaluated as components of the overall HHS rather than as separate outcome measures. Unit of Measure: Points on the Harris Hip Score, ranging from 0 to 100, with higher scores indicating better hip function.

Time frame
3 months and 6 months postoperatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yaser Alkanash

Lead sponsor

Idlib University

Sponsor institution

Source ClinicalTrials.gov
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