Evaluation of BDSF in FNFPhase 2RCTNCT07896031
BDSF Vs DHS With Anterotational Screw in Vertical FNF
A Phase 2 study testing Dynamic Hip Screw with Anterotation Screw Fixation and Biplane Double-Supported Screw Fixation in people with Evaluation of BDSF in FNF, run by Ain Shams University at 1 site in Egypt.
Trial summary
Pauwels type III femoral neck fractures in young adults commonly result from high-energy trauma and are characterized by a vertical fracture orientation with substantial shear and rotational forces. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Evaluation of BDSF in FNF
- What is being tested?
- Dynamic Hip Screw with Anterotation Screw Fixation and Biplane Double-Supported Screw Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 May 2027
- Phase
- Phase 2
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pauwels type III vertical femoral neck fracture
- Isolated femoral neck fracture
- Age between 18 and 50 years, inclusive
Who cannot join
- Pauwels type I or type II femoral neck fracture
- Associated pelvic ring or acetabular fracture requiring intervention
- Associated lower-extremity fracture requiring intervention
- Femoral neck fracture more than 14 days old
- Pathological fracture
- Age younger than 18 years or older than 50 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biplane Double Support Screw Fixation Versus Sliding Hip Screw With Antirotation Screw in Management of Pauwels Type III Neck of Femur Fractures in Young Adults: A Randomized Controlled Trial
Pauwels type III femoral neck fractures in young adults commonly result from high-energy trauma and are characterized by a vertical fracture orientation with substantial shear and rotational forces. These fractures are associated with an increased risk of mechanical instability, nonunion, varus collapse, fixation failure, and osteonecrosis of the femoral head. Successful treatment therefore requires anatomical reduction and stable internal fixation capable of resisting both vertical shear and rotational forces.
A Sliding Hip Screw combined with an antirotation screw provides controlled fracture compression and additional rotational stability. Biplane Double Support Screw Fixation is an alternative technique in which cannulated screws are inserted in two planes to provide double cortical support. The distal screw entry points and calcar-supported configuration are intended to distribute axial loading toward the femoral diaphysis, improve mechanical stability, facilitate fracture impaction, and reduce the risk of varus collapse.
Read more
This prospective randomized controlled study will compare Biplane Double Support Screw Fixation with Sliding Hip Screw fixation combined with an antirotation screw in young adults with Pauwels type III femoral neck fractures. Participants will be randomly allocated in a 1:1 ratio to receive one of the two fixation techniques.
The study will compare fracture healing, functional recovery, radiological outcomes, and postoperative complications between the two groups. Particular attention will be given to nonunion, osteonecrosis of the femoral head, varus collapse, implant failure, and the need for additional surgery. The study hypothesis is that Biplane Double Support Screw Fixation may provide stable fixation with clinical and radiological outcomes comparable or superior to those achieved using a Sliding Hip Screw with an antirotation screw.
Read the detailed description
This prospective, randomized, controlled clinical study will be conducted at Ain Shams University Hospitals. Participants with acute Pauwels type III femoral neck fractures will be allocated in a 1:1 ratio using a computer-generated randomization table to undergo fixation using either Biplane Double Support Screw Fixation or a Sliding Hip Screw with an additional antirotation screw.
A minimum of 30 participants will be recruited, with 15 participants assigned to each treatment group. The sample size was calculated using a sample-size calculation program, with a two-sided alpha level of 0.05, statistical power exceeding 99%, and an anticipated dropout rate of 10%. The calculation was based on detecting a clinically meaningful difference in operative time between the two fixation techniques.
Preoperative assessment will include detailed history-taking, clinical examination, neurovascular evaluation of both lower limbs, and trauma assessment when clinically indicated. Radiographic evaluation will include an anteroposterior pelvic radiograph with both hips, a lateral radiograph of the affected hip, and radiographs of the entire femur and knee. Preoperative computed tomography of the pelvis will be performed when required to define the fracture configuration and assist surgical planning.
All procedures will be performed under anesthesia on a radiolucent operating table. Closed reduction will initially be attempted under fluoroscopic guidance. If satisfactory closed reduction cannot be achieved, open reduction will be performed through the Watson-Jones approach. A lateral approach will be used when adequate closed reduction is achieved.
Participants assigned to the first group will undergo Biplane Double Support Screw Fixation. Screws will be inserted in two supporting planes to provide fixation of the femoral neck fracture and resist vertical shear forces. Participants assigned to the second group will undergo fixation using a Sliding Hip Screw combined with an additional antirotation screw. Fluoroscopic anteroposterior and lateral views will be used intraoperatively to assess fracture reduction and implant position.
Postoperative management will be standardized for both groups. Antibiotic prophylaxis, thromboprophylaxis, analgesia, and neurovascular monitoring will be provided according to institutional protocols. Toe-touch weight bearing will be recommended during the first six postoperative weeks. Progressive partial weight bearing and physiotherapy will subsequently be initiated according to radiographic progression and fixation stability. Full weight bearing will generally be permitted after evidence of satisfactory fracture healing.
Clinical and radiographic follow-up will be performed at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. Sutures will be removed at the 2-week visit, and passive and assisted active hip range-of-motion exercises will be initiated. Progressive weight bearing and strengthening exercises will begin during subsequent visits according to clinical and radiographic findings.
Data will be analyzed using the Statistical Package for the Social Sciences. Quantitative variables with a normal distribution will be summarized using means and standard deviations, while non-normally distributed variables will be presented using medians and interquartile ranges. Categorical variables will be summarized using frequencies and percentages. Appropriate statistical tests will be selected according to the type and distribution of the data. All statistical tests will be two-sided, and a P value of less than 0.05 will be considered statistically significant.
Written informed consent will be obtained from all participants before enrollment. The study will be conducted in accordance with applicable institutional ethical standards and will receive approval from the Faculty of Medicine, Ain Shams University Research Ethics Committee.
- Conditions
- Evaluation of BDSF in FNF
- Being tested
- Dynamic Hip Screw with Anterotation Screw Fixation, Biplane Double-Supported Screw Fixation
- Keywords
- Biplane double support, femoral neck fractures, Dynamic hip Screw, Pauwel angle, vertical fractures
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Hip Screw with Anterotation Screw FixationProcedure or surgery
nternal fixation of the femoral neck fracture using a dynamic hip screw with a side plate, supplemented with a parallel antirotation screw to improve rotational stability of the femoral head and neck fragment.
Biplane Double-Supported Screw FixationProcedure or surgery
Internal fixation of the femoral neck fracture using three cannulated screws inserted according to the biplane double-supported screw fixation technique. The screws will be positioned in two oblique planes to obtain cortical support at the femoral neck and improve the biomechanical stability of the fracture fixation.
| Study group | Role | What they receive |
|---|---|---|
| Fixation of Pauwel III femoral neck fractures via DHS and Anterotational Screw | Active comparator | DHS with anterotational screw for management of vertical femoral neck fractures as the standard of use Receives: Procedure: Dynamic Hip Screw with Anterotation Screw Fixation |
| Fixation of Pauwel III femoral neck fractures via BDSF | Experimental | We used biplanar double support screw fixation for management of vertical femoral neck fractures Receives: Procedure: Biplane Double-Supported Screw Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of nonunion
Nonunion will be assessed using serial anteroposterior and lateral hip radiographs. It will be defined as failure of fracture healing with a persistent fracture line and absence of progressive trabecular or cortical bridging across the fracture site, with or without persistent pain during weight bearing, at 9 months after fixation. Cases requiring revision surgery for failure of fracture healing before the 9-month assessment will also be classified as nonunion. Radiographs will be independently evaluated by two orthopedic surgeons, with disagreements resolved by consensus. The nonunion rate will be calculated as the number of patients meeting the nonunion criteria divided by the total number of evaluable patients, multiplied by 100.
Measured: up to 1 year postoperative
Functional outcome assessed using the Harris Hip Score was evaluated and calculated at each follow-up visit, with the mean value presented
Hip function will be evaluated using the Harris Hip Score (HHS), which assesses pain, function, absence of deformity, and hip range of motion. The total score ranges from 0 to 100 points, with higher scores indicating better hip function. Results will be classified as excellent (90-100), good (80-89), fair (70-79), or poor (<70). The mean HHS and the proportion of patients within each functional category will be reported.
Measured: At 3, 6, and 12 months after surgery.
Rate of osteonecrosis of the femoral head
Osteonecrosis of the femoral head will be assessed using serial anteroposterior and lateral hip radiographs. Diagnosis will be based on the development of characteristic radiographic changes, including femoral head sclerosis, cystic changes, subchondral collapse, crescent sign, or loss of femoral head sphericity. Magnetic resonance imaging will be performed when osteonecrosis is clinically suspected but not confirmed on plain radiographs. Osteonecrosis will be classified according to the Association Research Circulation Osseous (ARCO) classification. Patients who undergo revision surgery or conversion to hip arthroplasty because of osteonecrosis will be considered to have reached the outcome. The osteonecrosis rate will be calculated as the number of patients diagnosed with osteonecrosis divided by the total number of evaluable patients, multiplied by 100.
Measured: Up to 12 months after surgery.
Secondary outcomes (3)
Mean Operative Time
The mean operation time was calculated and compared between the two study groups
Measured: It was calculated intra-operative
Mean Intraoperative Blood Loss
The mean blood loss was calculated and compared between the two study groups; it was measured intraoperatively and postoperative from suction drains
Measured: Up to 4 days postoperative
Need For Another Operations' Rate
The need for another operation was observed and compared between the two study groups
Measured: Through study completion, an average of 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Sep 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of BDSF in FNFStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An independent doctor created the randomization sequence using Excel 2016 (computerized random numbers) with a 1:1 allocation via random block sizes of 2, 4, and 6; he assigned the sample numbers equally to each group and assigned the block. Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. We prospectively carried out this study on 30 patients with Pauwel III femoral neck fractures between september 2024 and july 2026 that met our inclusion criteria. The independent doctor allocated the 30 cases to two groups: Group A (15 cases): Biplane Double Support Screw fixation (BDSF fixation group) , group B (15 cases): Dynamic Hip Screw (DHS with Anterotational screw group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Moussa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896031
- Sponsor's protocol ID
- FMASU R191/2024
- Acronym
- RCT
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biplane Double Support Screw Fixation Versus Sliding Hip Screw With Antirotation Screw in Management of Pauwels Type III Neck of Femur Fractures in Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07896031
- Acronym / sponsor ID
- RCT / FMASU R191/2024
- Conditions
- Evaluation of BDSF in FNF
- Keywords
- Biplane double support, femoral neck fractures, Dynamic hip Screw, Pauwel angle, vertical fractures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 26 Oct 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.
Pauwels type III femoral neck fractures in young adults commonly result from high-energy trauma and are characterized by a vertical fracture orientation with substantial shear and rotational forces. These fractures are associated with an increased risk of mechanical instability, nonunion, varus collapse, fixation failure, and osteonecrosis of the femoral head. Successful treatment therefore requires anatomical reduction and stable internal fixation capable of resisting both vertical shear and rotational forces.
A Sliding Hip Screw combined with an antirotation screw provides controlled fracture compression and additional rotational stability. Biplane Double Support Screw Fixation is an alternative technique in which cannulated screws are inserted in two planes to provide double cortical support. The distal screw entry points and calcar-supported configuration are intended to distribute axial loading toward the femoral diaphysis, improve mechanical stability, facilitate fracture impaction, and reduce the risk of varus collapse.
This prospective randomized controlled study will compare Biplane Double Support Screw Fixation with Sliding Hip Screw fixation combined with an antirotation screw in young adults with Pauwels type III femoral neck fractures. Participants will be randomly allocated in a 1:1 ratio to receive one of the two fixation techniques.
The study will compare fracture healing, functional recovery, radiological outcomes, and postoperative complications between the two groups. Particular attention will be given to nonunion, osteonecrosis of the femoral head, varus collapse, implant failure, and the need for additional surgery. The study hypothesis is that Biplane Double Support Screw Fixation may provide stable fixation with clinical and radiological outcomes comparable or superior to those achieved using a Sliding Hip Screw with an antirotation screw.
Detailed description
This prospective, randomized, controlled clinical study will be conducted at Ain Shams University Hospitals. Participants with acute Pauwels type III femoral neck fractures will be allocated in a 1:1 ratio using a computer-generated randomization table to undergo fixation using either Biplane Double Support Screw Fixation or a Sliding Hip Screw with an additional antirotation screw.
A minimum of 30 participants will be recruited, with 15 participants assigned to each treatment group. The sample size was calculated using a sample-size calculation program, with a two-sided alpha level of 0.05, statistical power exceeding 99%, and an anticipated dropout rate of 10%. The calculation was based on detecting a clinically meaningful difference in operative time between the two fixation techniques.
Preoperative assessment will include detailed history-taking, clinical examination, neurovascular evaluation of both lower limbs, and trauma assessment when clinically indicated. Radiographic evaluation will include an anteroposterior pelvic radiograph with both hips, a lateral radiograph of the affected hip, and radiographs of the entire femur and knee. Preoperative computed tomography of the pelvis will be performed when required to define the fracture configuration and assist surgical planning.
All procedures will be performed under anesthesia on a radiolucent operating table. Closed reduction will initially be attempted under fluoroscopic guidance. If satisfactory closed reduction cannot be achieved, open reduction will be performed through the Watson-Jones approach. A lateral approach will be used when adequate closed reduction is achieved.
Participants assigned to the first group will undergo Biplane Double Support Screw Fixation. Screws will be inserted in two supporting planes to provide fixation of the femoral neck fracture and resist vertical shear forces. Participants assigned to the second group will undergo fixation using a Sliding Hip Screw combined with an additional antirotation screw. Fluoroscopic anteroposterior and lateral views will be used intraoperatively to assess fracture reduction and implant position.
Postoperative management will be standardized for both groups. Antibiotic prophylaxis, thromboprophylaxis, analgesia, and neurovascular monitoring will be provided according to institutional protocols. Toe-touch weight bearing will be recommended during the first six postoperative weeks. Progressive partial weight bearing and physiotherapy will subsequently be initiated according to radiographic progression and fixation stability. Full weight bearing will generally be permitted after evidence of satisfactory fracture healing.
Clinical and radiographic follow-up will be performed at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. Sutures will be removed at the 2-week visit, and passive and assisted active hip range-of-motion exercises will be initiated. Progressive weight bearing and strengthening exercises will begin during subsequent visits according to clinical and radiographic findings.
Data will be analyzed using the Statistical Package for the Social Sciences. Quantitative variables with a normal distribution will be summarized using means and standard deviations, while non-normally distributed variables will be presented using medians and interquartile ranges. Categorical variables will be summarized using frequencies and percentages. Appropriate statistical tests will be selected according to the type and distribution of the data. All statistical tests will be two-sided, and a P value of less than 0.05 will be considered statistically significant.
Written informed consent will be obtained from all participants before enrollment. The study will be conducted in accordance with applicable institutional ethical standards and will receive approval from the Faculty of Medicine, Ain Shams University Research Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- An independent doctor created the randomization sequence using Excel 2016 (computerized random numbers) with a 1:1 allocation via random block sizes of 2, 4, and 6; he assigned the sample numbers equally to each group and assigned the block. Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. We prospectively carried out this study on 30 patients with Pauwel III femoral neck fractures between september 2024 and july 2026 that met our inclusion criteria. The independent doctor allocated the 30 cases to two groups: Group A (15 cases): Biplane Double Support Screw fixation (BDSF fixation group) , group B (15 cases): Dynamic Hip Screw (DHS with Anterotational screw group).
| Arm | Type | Receives |
|---|---|---|
| Fixation of Pauwel III femoral neck fractures via DHS and Anterotational Screw | Active comparator | Procedure: Dynamic Hip Screw with Anterotation Screw FixationDHS with anterotational screw for management of vertical femoral neck fractures as the standard of use |
| Fixation of Pauwel III femoral neck fractures via BDSF | Experimental | Procedure: Biplane Double-Supported Screw FixationWe used biplanar double support screw fixation for management of vertical femoral neck fractures |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pauwels type III vertical femoral neck fracture
- Isolated femoral neck fracture
- Age between 18 and 50 years, inclusive
Key exclusion criteria (6 listed)
- Pauwels type I or type II femoral neck fracture
- Associated pelvic ring or acetabular fracture requiring intervention
- Associated lower-extremity fracture requiring intervention
- Femoral neck fracture more than 14 days old
- Pathological fracture
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 |
|---|---|---|
| Dynamic Hip Screw with Anterotation Screw Fixationnternal fixation of the femoral neck fracture using a dynamic hip screw with a side plate, supplemented with a parallel antirotation screw to improve rotational stability of the femoral head and neck fragment. | Procedure or surgery | Fixation of Pauwel III femoral neck fractures via DHS and Anterotational Screw |
| Biplane Double-Supported Screw FixationInternal fixation of the femoral neck fracture using three cannulated screws inserted according to the biplane double-supported screw fixation technique. The screws will be positioned in two oblique planes to obtain cortical support at the femoral neck and improve the biomechanical stability of the fracture fixation. | Procedure or surgery | Fixation of Pauwel III femoral neck fractures via BDSF |
Primary outcome
Rates of nonunion
Time frame: up to 1 year postoperative
Nonunion will be assessed using serial anteroposterior and lateral hip radiographs. It will be defined as failure of fracture healing with a persistent fracture line and absence of progressive trabecular or cortical bridging across the fracture site, with or without persistent pain during weight bearing, at 9 months after fixation. Cases requiring revision surgery for failure of fracture healing before the 9-month assessment will also be classified as nonunion. Radiographs will be independently evaluated by two orthopedic surgeons, with disagreements resolved by consensus. The nonunion rate will be calculated as the number of patients meeting the nonunion criteria divided by the total number of evaluable patients, multiplied by 100.
Functional outcome assessed using the Harris Hip Score was evaluated and calculated at each follow-up visit, with the mean value presented
Time frame: At 3, 6, and 12 months after surgery.
Hip function will be evaluated using the Harris Hip Score (HHS), which assesses pain, function, absence of deformity, and hip range of motion. The total score ranges from 0 to 100 points, with higher scores indicating better hip function. Results will be classified as excellent (90-100), good (80-89), fair (70-79), or poor (<70). The mean HHS and the proportion of patients within each functional category will be reported.
Rate of osteonecrosis of the femoral head
Time frame: Up to 12 months after surgery.
Osteonecrosis of the femoral head will be assessed using serial anteroposterior and lateral hip radiographs. Diagnosis will be based on the development of characteristic radiographic changes, including femoral head sclerosis, cystic changes, subchondral collapse, crescent sign, or loss of femoral head sphericity. Magnetic resonance imaging will be performed when osteonecrosis is clinically suspected but not confirmed on plain radiographs. Osteonecrosis will be classified according to the Association Research Circulation Osseous (ARCO) classification. Patients who undergo revision surgery or conversion to hip arthroplasty because of osteonecrosis will be considered to have reached the outcome. The osteonecrosis rate will be calculated as the number of patients diagnosed with osteonecrosis divided by the total number of evaluable patients, multiplied by 100.
3 secondary outcomes
Mean Operative Time
Time frame: It was calculated intra-operative
Mean Intraoperative Blood Loss
Time frame: Up to 4 days postoperative
Need For Another Operations' Rate
Time frame: Through study completion, an average of 1 year postoperative
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 26 Oct 2026.
- De Franco S, Ipponi E, Ruinato AD, Parchi PD, Andreani L, Scaglione M, Capanna R. Femoral neck fractures treated with cannulated screws: can surgeons predict functional outcomes and minimize the risk of necrosis? Acta Biomed. 2023 Feb 13;94(1):e20230Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dynamic Hip Screw with Anterotation Screw Fixation and Biplane Double-Supported Screw Fixation in people with Evaluation of BDSF in FNF, run by Ain Shams 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of nonunion (time frame: up to 1 year postoperative). 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?
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 26 Oct 2026.