ClinicalTrials.gg
RecruitingNCT04494672Updated Sep 9, 2026

A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System

An interventional study of Intramedullary nailing with ADAPT system and Intramedullary nailing without ADAPT system in Femoral Fracture, sponsored by Christian Candrian. Recruiting at 1 site in Switzerland. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Christian Candrian · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2020; still recruiting 6 years 1 month later.

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Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies in Femoral Fractures with a site in Switzerland — 2 open to participants now, 3 under way, none of them phase 3. Femoral Fractures · Switzerland.

Started
2020
the only one that year
No phase
5 of 10
2 open now
Registered
8th of 10
by date
Lead sponsor
1 of 10
Christian Candrian

Among the 10 studies in Femoral Fractures with a site in Switzerland, this one is the only one that started in 2020, is one of 5 with no phase, and was the 8th registered.

Femoral Fractures

186 studies on the registry are indexed under Femoral Fractures; 38 are open to participants now.

Browse Femoral Fractures studies →

Open to participants now

2 of the 10 studies in Femoral Fractures with a site in Switzerland are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 25 Femoral Fractures studies recruiting now, 14 (56%) set no upper age limit and 2 (8%) stop at 75 or younger; 2 take children under 18; 3 take healthy volunteers.

This study: 50 Years to 85 Years · all sexes · no healthy volunteers.

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02

Study 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. 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

03

Conditions studied

  • Femoral Fracture

Browse trials for

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing unilateral primary intramedullary nailing at the Ospedale Regionale di Lugano.
  • Patients aged 50-85 years old.
  • Patients with a >18 and \<35.
  • Patients able to provide 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.

Exclusion criteria

Exclusion Criteria:

  • Other 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Intramedullary nailing with ADAPT system (arm-A)

    A commercial product, namely ADAPT will be used as investigation product in arm-A

    Procedure: Intramedullary nailing with ADAPT system

  • Active comparator
    Intramedullary nailing without ADAPT system (arm-B)

    No aid in performing intramedullary nailing for proximal femoral fractures will be implemented in arm-B

    Procedure: Intramedullary nailing without ADAPT system

Interventions

  • ProcedureIntramedullary nailing with ADAPT system

    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

  • ProcedureIntramedullary nailing without ADAPT system

    Intramedullary nailing without ADAPT system

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: immediately after the surgery

Secondary outcomes

  1. time of the procedure

    time

    Time frame: immediately after the surgery

  2. intraoperative blood loss

    intraoperative blood loss

    Time frame: during the surgery

  3. intraoperative radiation time

    intraoperative radiation time

    Time frame: during the surgery

  4. 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

    Time frame: immediately after the surgery

  5. non-union

    fracture not alligned

    Time frame: at 6 weeks, 3 months, 6 months and 1-year

  6. cut-through rate

    cut-through rate

    Time frame: at 6 weeks, 3 months, 6 months and 1-year

  7. cut-out rate

    cut-out rate

    Time frame: at 6 weeks, 3 months, 6 months and 1-year

  8. VAS

    Visual pain analogue scale, \[from 0 (no pain) to 10 (worst pain)\]

    Time frame: at 6 weeks, 3 months, 6 months and 1-year

  9. Oxford Hip Score, [from 0 (severe hip arthritis) to 48 ( satisfactory joint function)]

    Hip function

    Time frame: at 6 weeks, 3 months, 6 months and 1-year

Other outcomes

  1. re-fracture rates

    re-fracture rates

    Time frame: at 6 weeks, 3 months, 6 months and 1-year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — not foreseen

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2020 (actual). Primary completion is estimated for Aug 2028, 94 months after the start.

Of 50 non-industry interventional studies with no phase under Femoral Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 50. This study's planned 94 months is above that.

Counting every sponsor, half of 53 studies reached it within 23 months; a quarter within 9 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2020
First posted
Jul 31, 2020
StartActual
Sep 28, 2020
Primary completionEst.
Aug 1, 2028
CompletionEst.
Aug 1, 2028
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04494672
Lead sponsor
Christian Candrian
Responsible party
Christian Candrian (Prof. Dr. Med., Ente Ospedaliero Cantonale, Bellinzona) — Sponsor-investigator
First posted
Jul 31, 2020
Start date
Sep 28, 2020
Primary completion
Aug 1, 2028 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Christian Candrian, MD
Contact
RicercaOrtopedia.ORL@eoc.ch
0041918117029
Christian Candrian, MD
principal investigator · Ente Ospedaliero Cantonale, Bellinzona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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