Bone Marrow Injection in Fracture of Femoral Neck

NCT07808294 | Recruiting DMC

• 1 other identifier: IU-REC-101-2026
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Marrow; Femoral Neck Fractures

Keywords

bone marrow; femoral neck; intracapsular fracture; avascular necrosis

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months postoperatively.

• 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: Up to 6 months ]

• . 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: 6 months postoperatively.]

Secondary Outcomes (1)

• Harris Hip Score (HHS)

  3 months and 6 months postoperatively.

Study Arms (2)

Group A:fixation using three fully threaded cancellous

ACTIVE COMPARATOR

Patients will undergo surgical intervention on the fractured hip under appropriate anesthesia. 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.

Procedure: Anatomical reduction with Fixation

Group B: Fixation using three fully cancellous screws with injection of autologous bone marrow

EXPERIMENTAL

Patients will undergo the same surgical procedure under appropriate anesthesia, with anatomical reduction of the fracture achieved under fluoroscopic guidance. The fracture will then be fixed through a lateral surgical approach using three fully threaded cancellous screws, in addition to the following procedure After drilling through the lateral femoral cortex toward the fracture line and advancing to the femoral head up to the subchondral bone, approximately 1-1.5 cm below the articular surface of the femoral head, 15 mL of autologous bone marrow will be aspirated from the iliac crest, approximately 1 cm posterior to the anterior superior iliac spine (ASIS), after ensuring that the site is included within the surgical field. The aspirate will be distributed into three heparin-prepared tubes. The harvested autologous bone marrow will then be injected through the prepared screw channels to ensure delivery of the graft to the fracture site. The screws will subsequently be inserted.

Procedure: Anatomical reduction and fixation with bone marrow injection

Interventions

Anatomical reduction with Fixation PROCEDURE

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.

Group A:fixation using three fully threaded cancellous

Anatomical reduction and fixation with bone marrow injection PROCEDURE

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

Group B: Fixation using three fully cancellous screws with injection of autologous bone marrow

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yaser Alkanash: lead

Study Sites (1)

Idlib university Faculty of medicine

Idlib, Syria

RECRUITING

Related Publications (3)

• Licheng Z, Lihai Z, Meng X, Qi Y, Peifu T. Autologous uncultured bone marrow-derived mononuclear cells and modified cannulated screw in repair of femoral neck fracture. J Orthop Res. 2013 Aug;31(8):1302-7. doi: 10.1002/jor.22346. Epub 2013 Mar 28.

  PMID: 23553771 BACKGROUND

• Sadat-Ali M, Ahlberg A. Fractured neck of the femur in young adults. Injury. 1992;23(5):311-3. doi: 10.1016/0020-1383(92)90176-s.

  PMID: 1644460 BACKGROUND

• Shah AK, Eissler J, Radomisli T. Algorithms for the treatment of femoral neck fractures. Clin Orthop Relat Res. 2002 Jun;(399):28-34. doi: 10.1097/00003086-200206000-00005.

  PMID: 12011691 BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures; Osteonecrosis

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamad M ISSA, MD

CONTACT

0954233150; mohamadalessa888@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dean of Scientific Affairs - Idlib University

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 8, 2026
• Study Start: May 12, 2025
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Individual participant data will become available after publication of the primary study results.
• Access Criteria: Anonymized individual participant data will be shared with qualified researchers upon reasonable request and approval by the study sponsor/institutional review committee. Data access will be subject to appropriate data-use and confidentiality agreements. De-identified individual participant data underlying the reported results may be shared with qualified researchers for scientifically appropriate research purposes, subject to ethical and institutional requirements.

Locations

SY (1)