Intertrochanteric Femur FractureDistal LockingNCT07772271
Dynamic Versus Static Distal Interlocking In AO/OTA 31A2 Intertrochanteric Femur Fractures: A Prospective Randomized Controlled Trial
A study testing Dynamic Distal Interlocking Intramedullary Nailing and Static Distal Interlocking Intramedullary Nailing in people with Intertrochanteric Femur Fracture, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
AO/OTA 31A2 intertrochanteric femur fractures are unstable injuries commonly treated with cephalomedullary nailing. However, the optimal distal locking configuration for short proximal femoral nails remains uncertain. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intertrochanteric Femur Fracture
- What is being tested?
- Dynamic Distal Interlocking Intramedullary Nailing and Static Distal Interlocking Intramedullary Nailing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2020to 15 Dec 2024
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older.
- Radiographically confirmed AO/OTA 31A2 intertrochanteric femur fracture.
- Planned surgical treatment using the study proximal femoral nail system.
- Provision of written informed consent.
Who cannot join
- Fracture pattern other than AO/OTA 31A2.
- Pathological fracture.
- Polytrauma.
- Previous surgery involving the ipsilateral hip or femur.
- Incomplete baseline radiographic data.
- Declined participation or inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences İzmir Bozyaka Training and Research Hospital
Izmir, İzmir, 35170
About this study
AO/OTA 31A2 intertrochanteric femur fractures are unstable injuries commonly treated with cephalomedullary nailing. However, the optimal distal locking configuration for short proximal femoral nails remains uncertain. This prospective, single-center, parallel-group randomized trial compared dynamic and static distal interlocking of a single short proximal femoral nail design in patients aged 65 years or older with AO/OTA 31A2 fractures. A total of 111 participants were randomized in a 1:1 ratio to dynamic or static distal locking and were followed for a minimum of 24 months. The study evaluated hip function, fracture union and time to union, established non-union, cephalic lag-screw backout, distal cortical thickening, peri-implant fracture, and reoperation or revision surgery.
Read the detailed description
Participants undergoing surgical treatment for AO/OTA 31A2 intertrochanteric femur fractures were prospectively enrolled at a single center and randomly allocated to dynamic or static distal interlocking. Both groups were treated using the same short proximal femoral nail design; the distal locking configuration was the principal difference between the treatment groups. Participants were not informed of their allocated locking configuration, whereas the treating surgeons and outcome assessors were not blinded.
Clinical and radiographic follow-up was performed for a minimum of 24 months. Hip function was assessed using the Harris Hip Score. Radiographic assessment included fracture union, time to union, established non-union, cephalic lag-screw backout, and distal cortical thickening. Peri-implant fractures and unplanned reoperations or revision procedures were also recorded.
Fracture union was defined as bridging callus across at least three cortices on anteroposterior and lateral radiographs together with absence of fracture-site pain during weight bearing. Established non-union was defined as absence of progressive healing at or beyond 6 months, persistent fracture-line visibility and fracture-site pain during weight bearing, and failure to achieve bridging union on serial radiographs. Mechanical failure alone was not considered sufficient to establish non-union.
The ethics-approved study documentation described the study objective as a comparison of radiographic and functional outcomes and complications but did not establish a formal hierarchy among individual outcome measures or identify a single primary endpoint.
- Conditions
- Intertrochanteric Femur Fracture
- Being tested
- Dynamic Distal Interlocking Intramedullary Nailing, Static Distal Interlocking Intramedullary Nailing
- Keywords
- Intertrochanteric Femur Fracture, AO/OTA 31A2, Distal Interlocking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Distal Interlocking Intramedullary NailingProcedure or surgery
Cephalomedullary fixation was performed using the study short proximal femoral nail. Distal interlocking was performed through the dynamic locking slot to permit controlled axial movement at the distal locking interface.
Static Distal Interlocking Intramedullary NailingProcedure or surgery
Cephalomedullary fixation was performed using the same study short proximal femoral nail. Distal interlocking was performed through the static locking hole to restrict axial movement at the distal locking interface.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Distal Interlocking Group | Experimental | Participants underwent fixation of an AO/OTA 31A2 intertrochanteric femur fracture using the study short proximal femoral nail with the distal locking screw placed in the dynamic locking slot. Receives: Procedure: Dynamic Distal Interlocking Intramedullary Nailing |
| Static Distal Interlocking Group | Active comparator | Participants underwent fixation of an AO/OTA 31A2 intertrochanteric femur fracture using the same study short proximal femoral nail with the distal locking screw placed in the static locking hole. Receives: Procedure: Static Distal Interlocking Intramedullary Nailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (HHS)
Overall hip function assessed using the Harris Hip Score (range, 0-100 points), with higher scores indicating better function.
Measured: At final follow-up (minimum 24 months after surgery).
Fracture Union, Time to Union, and Established Non-union
Fracture union was defined as bridging callus across at least three cortices on anteroposterior and lateral radiographs together with absence of fracture-site pain during weight bearing. Time to union was the interval from surgery to the first follow-up visit at which these criteria were met. Established non-union was defined as absence of progressive healing at or beyond 6 months, persistent fracture-line visibility and fracture-site pain during weight bearing, and failure to achieve bridging union on serial radiographs. Mechanical failure alone was not sufficient to establish non-union.
Measured: From surgery through final follow-up (minimum 24 months); established non-union assessed at or beyond 6 months.
Distal Cortical Thickening
New or progressive focal cortical hypertrophy around the distal locking screw or nail tip compared with immediate postoperative radiographs, assessed qualitatively as present or absent.
Measured: From immediate postoperative assessment through final follow-up (minimum 24 months).
Cephalic Lag-screw Backout
Change in cephalic lag-screw position, measured in millimeters on calibrated serial anteroposterior and lateral radiographs relative to the immediate postoperative radiographs.
Measured: From immediate postoperative assessment through final follow-up (minimum 24 months).
Secondary outcomes (2)
Peri-implant Fracture
Occurrence of a new fracture around the proximal femoral nail or at the nail tip during follow-up. The mechanism, anatomical location, and treatment were recorded.
Measured: From surgery through final follow-up (minimum 24 months).
Reoperation and Revision Procedure
Occurrence of any unplanned reoperation related to the index fracture or implant. Revision procedures, including conversion hemiarthroplasty, total hip arthroplasty, or plate osteosynthesis, were recorded.
Measured: From surgery through final follow-up (minimum 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start20 Dec 2020
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertrochanteric Femur FractureStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melikşah Uzakgider, Bozyaka Training and Research Hospital
- Investigators
- Melikşah U Uzakgider, M.D., Study director, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772271
- Sponsor's protocol ID
- 11; 16/12/2020
- Acronym
- Distal Locking
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the associated publication may be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Versus Static Distal Interlocking In AO/OTA 31A2 Intertrochanteric Femur Fractures: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07772271
- Acronym / sponsor ID
- Distal Locking / 11; 16/12/2020
- Conditions
- Intertrochanteric Femur Fracture
- Keywords
- Intertrochanteric Femur Fracture, AO/OTA 31A2, Distal Interlocking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 19 Aug 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.
AO/OTA 31A2 intertrochanteric femur fractures are unstable injuries commonly treated with cephalomedullary nailing. However, the optimal distal locking configuration for short proximal femoral nails remains uncertain. This prospective, single-center, parallel-group randomized trial compared dynamic and static distal interlocking of a single short proximal femoral nail design in patients aged 65 years or older with AO/OTA 31A2 fractures. A total of 111 participants were randomized in a 1:1 ratio to dynamic or static distal locking and were followed for a minimum of 24 months. The study evaluated hip function, fracture union and time to union, established non-union, cephalic lag-screw backout, distal cortical thickening, peri-implant fracture, and reoperation or revision surgery.
Detailed description
Participants undergoing surgical treatment for AO/OTA 31A2 intertrochanteric femur fractures were prospectively enrolled at a single center and randomly allocated to dynamic or static distal interlocking. Both groups were treated using the same short proximal femoral nail design; the distal locking configuration was the principal difference between the treatment groups. Participants were not informed of their allocated locking configuration, whereas the treating surgeons and outcome assessors were not blinded.
Clinical and radiographic follow-up was performed for a minimum of 24 months. Hip function was assessed using the Harris Hip Score. Radiographic assessment included fracture union, time to union, established non-union, cephalic lag-screw backout, and distal cortical thickening. Peri-implant fractures and unplanned reoperations or revision procedures were also recorded.
Fracture union was defined as bridging callus across at least three cortices on anteroposterior and lateral radiographs together with absence of fracture-site pain during weight bearing. Established non-union was defined as absence of progressive healing at or beyond 6 months, persistent fracture-line visibility and fracture-site pain during weight bearing, and failure to achieve bridging union on serial radiographs. Mechanical failure alone was not considered sufficient to establish non-union.
The ethics-approved study documentation described the study objective as a comparison of radiographic and functional outcomes and complications but did not establish a formal hierarchy among individual outcome measures or identify a single primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Distal Interlocking Group | Experimental | Procedure: Dynamic Distal Interlocking Intramedullary NailingParticipants underwent fixation of an AO/OTA 31A2 intertrochanteric femur fracture using the study short proximal femoral nail with the distal locking screw placed in the dynamic locking slot. |
| Static Distal Interlocking Group | Active comparator | Procedure: Static Distal Interlocking Intramedullary NailingParticipants underwent fixation of an AO/OTA 31A2 intertrochanteric femur fracture using the same study short proximal femoral nail with the distal locking screw placed in the static locking hole. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years or older.
- Radiographically confirmed AO/OTA 31A2 intertrochanteric femur fracture.
- Planned surgical treatment using the study proximal femoral nail system.
- Provision of written informed consent.
Key exclusion criteria (6 listed)
- Fracture pattern other than AO/OTA 31A2.
- Pathological fracture.
- Polytrauma.
- Previous surgery involving the ipsilateral hip or femur.
- Incomplete baseline radiographic data.
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 Distal Interlocking Intramedullary NailingCephalomedullary fixation was performed using the study short proximal femoral nail. Distal interlocking was performed through the dynamic locking slot to permit controlled axial movement at the distal locking interface. | Procedure or surgery | Dynamic Distal Interlocking Group |
| Static Distal Interlocking Intramedullary NailingCephalomedullary fixation was performed using the same study short proximal femoral nail. Distal interlocking was performed through the static locking hole to restrict axial movement at the distal locking interface. | Procedure or surgery | Static Distal Interlocking Group |
Primary outcome
Harris Hip Score (HHS)
Time frame: At final follow-up (minimum 24 months after surgery).
Overall hip function assessed using the Harris Hip Score (range, 0-100 points), with higher scores indicating better function.
Fracture Union, Time to Union, and Established Non-union
Time frame: From surgery through final follow-up (minimum 24 months); established non-union assessed at or beyond 6 months.
Fracture union was defined as bridging callus across at least three cortices on anteroposterior and lateral radiographs together with absence of fracture-site pain during weight bearing. Time to union was the interval from surgery to the first follow-up visit at which these criteria were met. Established non-union was defined as absence of progressive healing at or beyond 6 months, persistent fracture-line visibility and fracture-site pain during weight bearing, and failure to achieve bridging union on serial radiographs. Mechanical failure alone was not sufficient to establish non-union.
Distal Cortical Thickening
Time frame: From immediate postoperative assessment through final follow-up (minimum 24 months).
New or progressive focal cortical hypertrophy around the distal locking screw or nail tip compared with immediate postoperative radiographs, assessed qualitatively as present or absent.
Cephalic Lag-screw Backout
Time frame: From immediate postoperative assessment through final follow-up (minimum 24 months).
Change in cephalic lag-screw position, measured in millimeters on calibrated serial anteroposterior and lateral radiographs relative to the immediate postoperative radiographs.
2 secondary outcomes
Peri-implant Fracture
Time frame: From surgery through final follow-up (minimum 24 months).
Reoperation and Revision Procedure
Time frame: From surgery through final follow-up (minimum 24 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the associated publication may be made available upon reasonable request.
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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.
Melikşah U Uzakgider, M.D. study director
Izmir City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Distal Interlocking Intramedullary Nailing and Static Distal Interlocking Intramedullary Nailing in people with Intertrochanteric Femur Fracture, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 7 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Harris Hip Score (HHS) (time frame: At final follow-up (minimum 24 months after surgery).). The study lists 4 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 7 Oct 2026.