Femoral FractureNCT04494672
A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System
A study testing Intramedullary nailing with ADAPT system and Intramedullary nailing without ADAPT system in people with Femoral Fracture, run by Christian Candrian at 1 site in Switzerland.
Trial summary
The ADAPT system is a software that calculate a virtual 3D reconstruction of the femoral head without additional radiation. It automatically detects the used implant and its position relative to the femoral head, helping the surgeon to achieve an optimal proximal screw positioning in the femoral head. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Femoral Fracture
- What is being tested?
- Intramedullary nailing with ADAPT system and Intramedullary nailing without ADAPT system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Sep 2020to 1 Aug 2028
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral primary intramedullary nailing at the Ospedale Regionale di Lugano.
- Patients aged 50-85 years old.
- Patients with a BMI >18 and <35.
- Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
- Radiological evidence of proximal fracture of the femur, AO classified as 31 A1.3, 31 A2.1, 31 A2.2, 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3.
Who cannot join
- Other clinically significant concomitant disease states (e.g. renal failure, major hepatic dysfunction, life-threatening cardiovascular disease, etc..).
- Known or suspected non-compliance, drug or alcohol abuse.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Previous enrolment into the current study.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Christian Candrian
Lugano, 6900
Christian Candrian, Prof.Dr.med, +41 (0) 91 811 61 23, christian.candrian@eoc.ch
Gianluigi Capone, Dr., gianluigi.capone@eoc.ch
About this study
Official title: Improving Intramedullary Nailing of Proximal Femoral Fractures Through a Navigation Assisted Technique: a Double Blinded Randomized Control Trial
The ADAPT system is a software that calculate a virtual 3D reconstruction of the femoral head without additional radiation. It automatically detects the used implant and its position relative to the femoral head, helping the surgeon to achieve an optimal proximal screw positioning in the femoral head. The investigators want to verify if with the addition of the ADAPT system the investigators can improve screw placement and reduce surgery time and radiation exposure.
Read the detailed description
This study is a 2-arm randomized controlled trial comparing intramedullary nailing of proximal fracture of the femur (AO classified as 31 A1.3 , 31 A2.1, 31 A2.2 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3) performed with the ADAPT system (arm-A) and those performed without (arm-B).
The ADAPT system has been developed with the aim to reduce the rate of complications in intramedullary nailing and its usefulness has been previously explored only in two underpowered randomized controlled trials. Thanks to the possibility to track screw placement in real-time, allowing improved screw placement, the ADAPT system could be a valid tool, in order to minimize radiation exposure, surgical time, and rate of complications.
All the patients undergoing intramedullary nailing at the Ospedale Regionale di Lugano satisfying the eligibility criteria reported at section 7.1 will be enrolled in the study and randomly allocated (allocation ratio 1:1) to receive preoperatively:
- Intramedullary nailing with ADAPT system (arm-A)
- Intramedullary nailing without ADAPT system (arm-B) Patients and physicians evaluating the results will be blinded to the assigned group.
The total number of patients enrolled will be 96 (48 arm-A, 48 arm-B). After surgery, data about duration of the procedure, intraoperative blood loss, satisfaction of the surgeon and radiation exposure time will be collected.
Fracture healing, and rate of complications (cut-through and cut out) will be evaluated during all the follow-up visits, alongside VAS and a functional evaluation of the injured hip through the Oxford Hip score.
All treatment related adverse events will be reported up to follow-up visit 4, i.e. up to 12 ± 1 months.
Every patient will be involved in the trial for 1 year. The expected time to complete the trial is 4 years: 3 years for patient enrolment and 1 year to complete the last follow-up
- Conditions
- Femoral Fracture
- Being tested
- Intramedullary nailing with ADAPT system, Intramedullary nailing without ADAPT system
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary nailing with ADAPT systemProcedure or surgery
Stryker ADAPT®system (ADAPT, Stryker Leibinger GmbH \& Co. KG, Freiburg, Germany) is a computer navigation system which can reconstruct a 3D model of the femoral head from the positional information oriented by bidirectional fluoroscopic views. ADAPT shows the distance from the tip of the screw to the surface of the femoral head, tip-to-head-surface distance (TSD), and tip-apex distance (TAD) intraoperatively
Intramedullary nailing without ADAPT systemProcedure or surgery
Intramedullary nailing without ADAPT system
| Study group | Role | What they receive |
|---|---|---|
| Intramedullary nailing with ADAPT system (arm-A) | Experimental | A commercial product, namely ADAPT will be used as investigation product in arm-A Receives: Procedure: Intramedullary nailing with ADAPT system |
| Intramedullary nailing without ADAPT system (arm-B) | Active comparator | No aid in performing intramedullary nailing for proximal femoral fractures will be implemented in arm-B Receives: Procedure: Intramedullary nailing without ADAPT system |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAD (tip to apex) index at the post-operative X-Ray control prior discharge
The primary outcome of the study is the TAD (tip to apex) index at the post-operative X-Ray control prior discharge.
The TAD is the tip-apex distance, which is the sum of the distance from the tip of the lag screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. The percentage of cut-outs has been correlated directly to both the severity of proximal femoral fractures and the TAD.
Measured: immediately after the surgery
Secondary outcomes (9)
time of the procedure
time
Measured: immediately after the surgery
intraoperative blood loss
intraoperative blood loss
Measured: during the surgery
intraoperative radiation time
intraoperative radiation time
Measured: during the surgery
surgeon satisfaction on the satisfaction Numerical Rating Scale (NRS scale)
The satisfaction NRS is a self-assessment scale in which surgeons rate their satisfaction on an 11-point numerical scale from 0 (completely dissatisfied) to 10 (completely satisfied). The satisfaction NRS will be administered after surgery
Measured: immediately after the surgery
non-union
fracture not alligned
Measured: at 6 weeks, 3 months, 6 months and 1-year
cut-through rate
cut-through rate
Measured: at 6 weeks, 3 months, 6 months and 1-year
cut-out rate
cut-out rate
Measured: at 6 weeks, 3 months, 6 months and 1-year
VAS
Visual pain analogue scale, [from 0 (no pain) to 10 (worst pain)]
Measured: at 6 weeks, 3 months, 6 months and 1-year
Oxford Hip Score, [from 0 (severe hip arthritis) to 48 ( satisfactory joint function)]
Hip function
Measured: at 6 weeks, 3 months, 6 months and 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start28 Sep 2020
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Candrian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Candrian, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Christian Candrian, MD, Principal investigator, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494672
- Sponsor's protocol ID
- ORL-ORT-015
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2020
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not foreseen
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Intramedullary Nailing of Proximal Femoral Fractures Through a Navigation Assisted Technique: a Double Blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04494672
- Acronym / sponsor ID
- ORL-ORT-015
- Conditions
- Femoral Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Christian CandrianUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 31 Jul 2020 (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.
The ADAPT system is a software that calculate a virtual 3D reconstruction of the femoral head without additional radiation. It automatically detects the used implant and its position relative to the femoral head, helping the surgeon to achieve an optimal proximal screw positioning in the femoral head. The investigators want to verify if with the addition of the ADAPT system the investigators can improve screw placement and reduce surgery time and radiation exposure.
Detailed description
This study is a 2-arm randomized controlled trial comparing intramedullary nailing of proximal fracture of the femur (AO classified as 31 A1.3 , 31 A2.1, 31 A2.2 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3) performed with the ADAPT system (arm-A) and those performed without (arm-B).
The ADAPT system has been developed with the aim to reduce the rate of complications in intramedullary nailing and its usefulness has been previously explored only in two underpowered randomized controlled trials. Thanks to the possibility to track screw placement in real-time, allowing improved screw placement, the ADAPT system could be a valid tool, in order to minimize radiation exposure, surgical time, and rate of complications.
All the patients undergoing intramedullary nailing at the Ospedale Regionale di Lugano satisfying the eligibility criteria reported at section 7.1 will be enrolled in the study and randomly allocated (allocation ratio 1:1) to receive preoperatively:
- Intramedullary nailing with ADAPT system (arm-A)
- Intramedullary nailing without ADAPT system (arm-B) Patients and physicians evaluating the results will be blinded to the assigned group.
The total number of patients enrolled will be 96 (48 arm-A, 48 arm-B). After surgery, data about duration of the procedure, intraoperative blood loss, satisfaction of the surgeon and radiation exposure time will be collected.
Fracture healing, and rate of complications (cut-through and cut out) will be evaluated during all the follow-up visits, alongside VAS and a functional evaluation of the injured hip through the Oxford Hip score.
All treatment related adverse events will be reported up to follow-up visit 4, i.e. up to 12 ± 1 months.
Every patient will be involved in the trial for 1 year. The expected time to complete the trial is 4 years: 3 years for patient enrolment and 1 year to complete the last follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramedullary nailing with ADAPT system (arm-A) | Experimental | Procedure: Intramedullary nailing with ADAPT systemA commercial product, namely ADAPT will be used as investigation product in arm-A |
| Intramedullary nailing without ADAPT system (arm-B) | Active comparator | Procedure: Intramedullary nailing without ADAPT systemNo aid in performing intramedullary nailing for proximal femoral fractures will be implemented in arm-B |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing unilateral primary intramedullary nailing at the Ospedale Regionale di Lugano.
- Patients aged 50-85 years old.
- Patients with a BMI >18 and <35.
- Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
- Radiological evidence of proximal fracture of the femur, AO classified as 31 A1.3, 31 A2.1, 31 A2.2, 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3.
Key exclusion criteria (5 listed)
- Other clinically significant concomitant disease states (e.g. renal failure, major hepatic dysfunction, life-threatening cardiovascular disease, etc..).
- Known or suspected non-compliance, drug or alcohol abuse.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Previous enrolment into the current study.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
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 |
|---|---|---|
| Intramedullary nailing with ADAPT systemStryker ADAPT®system (ADAPT, Stryker Leibinger GmbH \& Co. KG, Freiburg, Germany) is a computer navigation system which can reconstruct a 3D model of the femoral head from the positional information oriented by bidirectional fluoroscopic views. ADAPT shows the distance from the tip of the screw to the surface of the femoral head, tip-to-head-surface distance (TSD), and tip-apex distance (TAD) intraoperatively | Procedure or surgery | Intramedullary nailing with ADAPT system (arm-A) |
| Intramedullary nailing without ADAPT systemIntramedullary nailing without ADAPT system | Procedure or surgery | Intramedullary nailing without ADAPT system (arm-B) |
Primary outcome
TAD (tip to apex) index at the post-operative X-Ray control prior discharge
Time frame: immediately after the surgery
The primary outcome of the study is the TAD (tip to apex) index at the post-operative X-Ray control prior discharge. The TAD is the tip-apex distance, which is the sum of the distance from the tip of the lag screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. The percentage of cut-outs has been correlated directly to both the severity of proximal femoral fractures and the TAD.
9 secondary outcomes
time of the procedure
Time frame: immediately after the surgery
intraoperative blood loss
Time frame: during the surgery
intraoperative radiation time
Time frame: during the surgery
surgeon satisfaction on the satisfaction Numerical Rating Scale (NRS scale)
Time frame: immediately after the surgery
non-union
Time frame: at 6 weeks, 3 months, 6 months and 1-year
cut-through rate
Time frame: at 6 weeks, 3 months, 6 months and 1-year
cut-out rate
Time frame: at 6 weeks, 3 months, 6 months and 1-year
VAS
Time frame: at 6 weeks, 3 months, 6 months and 1-year
Oxford Hip Score, [from 0 (severe hip arthritis) to 48 ( satisfactory joint function)]
Time frame: at 6 weeks, 3 months, 6 months and 1-year
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 9 Sep 2026.
- Individual participant dataSharing planned: No. not foreseen
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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.
Christian Candrian, MD principal investigator
Ente Ospedaliero Cantonale, Bellinzona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramedullary nailing with ADAPT system and Intramedullary nailing without ADAPT system in people with Femoral Fracture, run by Christian Candrian at 1 site in Switzerland.
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 5 inclusion and 5 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 9 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 Switzerland. 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 Christian Candrian, MD (0041918117029, RicercaOrtopedia.ORL@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAD (tip to apex) index at the post-operative X-Ray control prior discharge (time frame: immediately after the surgery). 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 9 Sep 2026.