Bone MarrowNCT07808294
Bone Marrow Injection in Fracture of Femoral Neck
A study testing Anatomical reduction and fixation with bone marrow injection and Anatomical reduction with Fixation in people with Bone Marrow and Femoral Neck Fractures, run by Yaser Alkanash at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bone Marrow, Femoral Neck Fractures
- What is being tested?
- Anatomical reduction and fixation with bone marrow injection and Anatomical reduction with Fixation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSyria
- Study dates
- 12 May 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Syria1 site, 1 recruiting
- Recruiting
Idlib university Faculty of medicine
Idlib
Yaser alkanash, +963 996 091 279, dr.yaseralkanash76@gmail.com
Ali Faraj, Phd
About this study
Official title: Outcome of Bone Marrow Injection at Fracture Site in Intracapsular Fracture of Femoral Neck Treated by Head Preserving Surgery
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:
Read more
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.
Read the detailed description
Femoral neck fractures are serious injuries associated with a high risk of complications and represent an important challenge in orthopedic practice. Treatment decisions depend on several factors, including the patient's age, physiological status, activity level, associated comorbidities, and fracture displacement. In younger patients and in those with nondisplaced or minimally displaced fractures, internal fixation is generally preferred because preservation of the native femoral head and hip joint is an important treatment goal.
Femoral neck fractures in young patients are usually caused by severe trauma and, although relatively uncommon, are associated with a high incidence of complications. Avascular necrosis (AVN) and late segmental collapse have been reported as major complications following these injuries, with particularly high complication rates described in young patients. Patients with subcapital fractures appear to be more susceptible to these complications. The high risk of AVN is related to the vulnerable blood supply of the femoral head, making preservation of femoral head vascularity a major concern in the treatment of femoral neck fractures.
For younger and active patients with displaced femoral neck fractures, anatomic reduction followed by stable internal fixation is considered essential, while internal fixation is also recommended for ambulatory patients with nondisplaced fractures to prevent secondary displacement. However, despite appropriate internal fixation, complications such as osteonecrosis and nonunion may still occur. The reported rate of osteonecrosis is approximately 10-30%, while nonunion has been reported in 8.9-30% of cases. These complications can lead to prolonged disability and may ultimately require additional surgical treatment.
Autologous bone grafting has traditionally been used to augment bone regeneration in cases of osteonecrosis and nonunion, but its use may be associated with donor-site complications, including pain, bleeding, and infection. Consequently, biological approaches that can enhance fracture healing without the morbidity associated with bone graft harvesting have attracted increasing interest.
Bone marrow(BM) represent a potential alternative biological approach because they contain cell populations with osteogenic and angiogenic potential. Autologous BM transplantation offers several potential advantages, including relatively rapid isolation, avoidance of prolonged cell expansion, preservation of early progenitor characteristics, and the ability to use the cells without a prolonged delay between harvesting and treatment. Previous studies have also suggested beneficial effects of autologous BM in the treatment of femoral head osteonecrosis.
Because prevention of osteonecrosis and nonunion is preferable to treating these complications after they have developed, biological augmentation at the time of fracture fixation may represent a promising strategy. Therefore, combining stable internal fixation with an autologous biological treatment may provide a potential approach to improving fracture healing and reducing the risk of complications in patients with femoral neck fractures.
- Conditions
- Bone Marrow, Femoral Neck Fractures
- Being tested
- Anatomical reduction and fixation with bone marrow injection, Anatomical reduction with Fixation
- Keywords
- bone marrow, femoral neck, intracapsular fracture, avascular necrosis
- Medical subject headings
- Femoral Neck Fractures, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical reduction and fixation with bone marrow injectionProcedure or 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 FixationProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Anatomical reduction and fixation with bone marrow injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: [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.
Measured: 3 months and 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start12 May 2025
- Primary completion12 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone MarrowStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaser Alkanash
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yaser Alkanash, Idlib University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808294
- Sponsor's protocol ID
- IU-REC-101-2026
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: site of injection and radiologic images
Publications
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.
PubMed 23553771Sadat-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.
PubMed 1644460Shah 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.
PubMed 12011691
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Bone Marrow Injection at Fracture Site in Intracapsular Fracture of Femoral Neck Treated by Head Preserving Surgery
- ClinicalTrials.gov ID
- NCT07808294
- Acronym / sponsor ID
- IU-REC-101-2026
- Conditions
- Bone Marrow, Femoral Neck Fractures
- Keywords
- bone marrow, femoral neck, intracapsular fracture, avascular necrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Yaser AlkanashUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 12 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 Sep 2026 (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.
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.
Detailed description
Femoral neck fractures are serious injuries associated with a high risk of complications and represent an important challenge in orthopedic practice. Treatment decisions depend on several factors, including the patient's age, physiological status, activity level, associated comorbidities, and fracture displacement. In younger patients and in those with nondisplaced or minimally displaced fractures, internal fixation is generally preferred because preservation of the native femoral head and hip joint is an important treatment goal.
Femoral neck fractures in young patients are usually caused by severe trauma and, although relatively uncommon, are associated with a high incidence of complications. Avascular necrosis (AVN) and late segmental collapse have been reported as major complications following these injuries, with particularly high complication rates described in young patients. Patients with subcapital fractures appear to be more susceptible to these complications. The high risk of AVN is related to the vulnerable blood supply of the femoral head, making preservation of femoral head vascularity a major concern in the treatment of femoral neck fractures.
For younger and active patients with displaced femoral neck fractures, anatomic reduction followed by stable internal fixation is considered essential, while internal fixation is also recommended for ambulatory patients with nondisplaced fractures to prevent secondary displacement. However, despite appropriate internal fixation, complications such as osteonecrosis and nonunion may still occur. The reported rate of osteonecrosis is approximately 10-30%, while nonunion has been reported in 8.9-30% of cases. These complications can lead to prolonged disability and may ultimately require additional surgical treatment.
Autologous bone grafting has traditionally been used to augment bone regeneration in cases of osteonecrosis and nonunion, but its use may be associated with donor-site complications, including pain, bleeding, and infection. Consequently, biological approaches that can enhance fracture healing without the morbidity associated with bone graft harvesting have attracted increasing interest.
Bone marrow(BM) represent a potential alternative biological approach because they contain cell populations with osteogenic and angiogenic potential. Autologous BM transplantation offers several potential advantages, including relatively rapid isolation, avoidance of prolonged cell expansion, preservation of early progenitor characteristics, and the ability to use the cells without a prolonged delay between harvesting and treatment. Previous studies have also suggested beneficial effects of autologous BM in the treatment of femoral head osteonecrosis.
Because prevention of osteonecrosis and nonunion is preferable to treating these complications after they have developed, biological augmentation at the time of fracture fixation may represent a promising strategy. Therefore, combining stable internal fixation with an autologous biological treatment may provide a potential approach to improving fracture healing and reducing the risk of complications in patients with femoral neck fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A:fixation using three fully threaded cancellous | Active comparator | Procedure: Anatomical reduction with FixationPatients 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. |
| Group B: Fixation using three fully cancellous screws with injection of autologous bone marrow | Experimental | Procedure: Anatomical reduction and fixation with bone marrow injectionPatients 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Anatomical reduction and fixation with bone marrow injectionAnatomical 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 | Procedure or surgery | Group B: Fixation using three fully cancellous screws with injection of autologous bone marrow |
| Anatomical reduction with FixationAnatomical 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 or surgery | Group A:fixation using three fully threaded cancellous |
Primary outcome
Fracture Union
Time frame: 6 months postoperatively.
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 to Fracture Union
Time frame: Time Frame: Up to 6 months ]
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
. Avascular Necrosis of the Femoral Head
Time frame: [Time Frame: 6 months postoperatively.]
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)
1 secondary outcome
Harris Hip Score (HHS)
Time frame: 3 months and 6 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 23553771Licheng 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.
- Background: PubMed 1644460Sadat-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.
- Background: PubMed 12011691Shah 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.
- Individual participant dataSharing planned: Yes. site of injection and radiologic images
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomical reduction and fixation with bone marrow injection and Anatomical reduction with Fixation in people with Bone Marrow and Femoral Neck Fractures, run by Yaser Alkanash at 1 site in Syria.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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 Syria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamad M ISSA, MD (0954233150, mohamadalessa888@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture Union (time frame: 6 months postoperatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808294, which also lists 3 linked publications.
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 8 Sep 2026.