Idiopathic Increased Femoral AnteversionFDRNCT04086368
The FDR (Femoral Derotaton) Trail.
A study testing Adolescent Lateral Entry Femoral Nail and Pediatric LCP Hip Plate System in people with Idiopathic Increased Femoral Anteversion, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Femoral derotational osteotomy is the gold standard to correct symptomatic patients with increased femoral AV. There is no clear evidence in the literature supporting which surgical technique or implant that should be used. Traditionally these patients are treated with an open osteotomy and plate and screw fixation. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Increased Femoral Anteversion
- What is being tested?
- Adolescent Lateral Entry Femoral Nail and Pediatric LCP Hip Plate System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNorway
- Study dates
- 22 Oct 2019to 16 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Radiographic findings: Femoral AV angle ≥ 30°
- Age 10-18 years.
- Hip or/and knee pain
- Less than 15 degrees external rotation of the hips
Who cannot join
- Patients will be excluded from the study if they meet any of the following criteria:
- Previous femoral injury or illness which reduces the function of the extremity
- Systemic or chronic injury or illness which reduces the function of the extremity
- If the patient is not able to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Derotational Femoral Osteotomy With Either Percutaneous Osteotomy and Intramedullary Nailing or Open Approach and Plating - a Randomized Controlled Trail
Femoral derotational osteotomy is the gold standard to correct symptomatic patients with increased femoral AV. There is no clear evidence in the literature supporting which surgical technique or implant that should be used. Traditionally these patients are treated with an open osteotomy and plate and screw fixation. In recent years intramedullary nailing with adolescent interlocking nail has been described and has shown to be a safe method. Percutaneous osteotomy and intramedullary nailing is considered a less invasive technique compared with open osteotomy and plate and screw fixation.
The primary objective of this project, is to investigate if derotational osteotomy by means of percutaneous osteotomy and nailing is a safe and accurate method compared to an open approach and plating.
Read the detailed description
Introduction:
Gait deviations in children may be caused by excessive femoral anteversion (AV). This rotational deformity is usually self-limiting but is a common cause of parental concern. Femoral anteversion is an inward twisting (rotation) of the femur. Excessive femoral anteversion causes the patients knees and feet to turn inwards and have a "pigeon-toed" appearance. The AV angle can be measured in the transverse plane by a line through the centre of the femoral head and neck and a tangential line across of the posterior femoral condyles. In the majority of cases of increased femoral AV, normalization occurs spontaneously during growth.
Persisting excessive femoral torsion after the age of 8 years may lead to tripping and anterior hip and knee pain. Recent studies have shown that increased internal rotation is a risk factor for patellofemoral instability and may result in patellofemoral contact pressure.
There are no studies supporting conservative treatment with physiotherapy or braces. Femoral derotational osteotomy is the gold standard to correct symptomatic patients with increased femoral AV. Several techniques have been described and there is no clear evidence in the literature supporting which surgical technique or implant that should be used (3). Traditionally these patients are treated with an open osteotomy and plate and screw fixation. In recent years intramedullary nailing with adolescent interlocking nail has been described both for rotational osteotomies and femoral fractures. With a lateral trochanteric entry point this has been shown to be a safe method. Percutaneous osteotomy and intramedullary nailing is considered a less invasive technique compared with open osteotomy and plate and screw fixation.
Study aims:
The investigators want to compare percutaneous osteotomy and intramedullary nailing with an open approach and plating with interlocking screws, in a randomized, controlled single-center trial. Our hypothesis is that percutaneous osteotomy and intramedullary nailing is non-inferior in the treatment of increased femoral AV, compared to open approach with plate fixation.
The primary outcome measure is to measure the accuracy of the derotation at 12 months by CT scan.
Study design and methodology:
The study is a randomized non-inferiority trail comparing operative treatment of patients with symptomatic increased idiopathic femoral anteversion. There are two arms: (1) Open approach and plating and (2) percutaneous osteotomy and intramedullary nailing. The allocation ratio is 1:1.We will recruit patients in the age 10-18 years of age, referred to the Orthopedic department, Oslo University Hospital. A pediatric orthopedic surgeon will verify that the patient meets the inclusion criteria, and the patient will be given thorough oral and written information. After signed consent, the randomization allocation to treatment method will be performed by means of a web-solution made by NTNU WebCRF system with the approval from the OUS Head of Patient Security.
Follow-up:
The study patients will be followed-up over a one year period (6 weeks, 12 weeks, 12 months). All patients will be tested with 3 d gait analysis at 12 months and will be compared with the patients preoperativ 3 D gait analysis. All reoperations will be recorded.
- Conditions
- Idiopathic Increased Femoral Anteversion
- Being tested
- Adolescent Lateral Entry Femoral Nail, Pediatric LCP Hip Plate System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Lateral Entry Femoral NailDevice
The use of an less invasive implant that has the same accuracy.
Pediatric LCP Hip Plate SystemDevice
Open approach to the femur where the osteotomy and osteofixation with plate and screws are preformed
| Study group | Role | What they receive |
|---|---|---|
| The Synthes Pediatric LCP Plate System | Active comparator | Open osteotomy and osteofixation with the pediatric LCP hip plate Receives: Device: Pediatric LCP Hip Plate System |
| The adolescent Lateral Femoral Nail | Experimental | Percutaneous osteotomy and intramedullary nailing Receives: Device: Adolescent Lateral Entry Femoral Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the derotation
Accuracy of the derotation measured in degrees on CT comparing the intended/planned correction with the actual derotation
Measured: post operative (day1)
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score for Children (KOOS-Child)
39 items divided in 5 subscales; Pain, other Symptoms (titled as "knee problems"), Difficulty during daily activities (ADL), Function in sport and play (Sport/Play) and Knee related Quality of Life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Baseline, 26 week and 52 week follow-up
Visual analogue scale
General visual analog scale (VAS) for pain. scale is 0-10, where 10 is maximum pain og 0 is no pain. The scale is a 10 cm long line where the patient sets a mark. The actual level of pain is than measured on the scale from 0-10 (e.g. mark is at 5,5 cm - pain score 5,5)
Measured: Baseline, daily first six week. 4 times a day.
KIDSCREEN-27
The KIDSCREEN-27 is a globally used standardized health-related quality of life questionnaire measuring five Rasch scaled dimensions of wellbeing including: (1) Physical Well-being (5 items), (2) Psychological Well-being (7 items), (3) Autonomy and Parents (7 items), (4) Peers and Social Support (4 items), and (5) School Environment (4 items). Responses are indicated using a 5-point ordinal scale with responses ranging from 'never' to 'always', 'not at all' to 'extremely', or 'poor' to 'excellent'.
Measured: Baseline, 26 week, 52 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start22 Oct 2019
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Increased Femoral AnteversionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Grønseth, Oslo University Hospital
- Investigators
- Anders Grønseth, M.D, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086368
- Sponsor's protocol ID
- 2018/2175
- Acronym
- FDR
- Status last verified
- Dec 2024
- First submitted
- 26 Aug 2019
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derotational Femoral Osteotomy With Either Percutaneous Osteotomy and Intramedullary Nailing or Open Approach and Plating - a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT04086368
- Acronym / sponsor ID
- FDR / 2018/2175
- Conditions
- Idiopathic Increased Femoral Anteversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 11 Sep 2019 (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.
Femoral derotational osteotomy is the gold standard to correct symptomatic patients with increased femoral AV. There is no clear evidence in the literature supporting which surgical technique or implant that should be used. Traditionally these patients are treated with an open osteotomy and plate and screw fixation. In recent years intramedullary nailing with adolescent interlocking nail has been described and has shown to be a safe method. Percutaneous osteotomy and intramedullary nailing is considered a less invasive technique compared with open osteotomy and plate and screw fixation.
The primary objective of this project, is to investigate if derotational osteotomy by means of percutaneous osteotomy and nailing is a safe and accurate method compared to an open approach and plating.
Detailed description
Introduction:
Gait deviations in children may be caused by excessive femoral anteversion (AV). This rotational deformity is usually self-limiting but is a common cause of parental concern. Femoral anteversion is an inward twisting (rotation) of the femur. Excessive femoral anteversion causes the patients knees and feet to turn inwards and have a "pigeon-toed" appearance. The AV angle can be measured in the transverse plane by a line through the centre of the femoral head and neck and a tangential line across of the posterior femoral condyles. In the majority of cases of increased femoral AV, normalization occurs spontaneously during growth.
Persisting excessive femoral torsion after the age of 8 years may lead to tripping and anterior hip and knee pain. Recent studies have shown that increased internal rotation is a risk factor for patellofemoral instability and may result in patellofemoral contact pressure.
There are no studies supporting conservative treatment with physiotherapy or braces. Femoral derotational osteotomy is the gold standard to correct symptomatic patients with increased femoral AV. Several techniques have been described and there is no clear evidence in the literature supporting which surgical technique or implant that should be used (3). Traditionally these patients are treated with an open osteotomy and plate and screw fixation. In recent years intramedullary nailing with adolescent interlocking nail has been described both for rotational osteotomies and femoral fractures. With a lateral trochanteric entry point this has been shown to be a safe method. Percutaneous osteotomy and intramedullary nailing is considered a less invasive technique compared with open osteotomy and plate and screw fixation.
Study aims:
The investigators want to compare percutaneous osteotomy and intramedullary nailing with an open approach and plating with interlocking screws, in a randomized, controlled single-center trial. Our hypothesis is that percutaneous osteotomy and intramedullary nailing is non-inferior in the treatment of increased femoral AV, compared to open approach with plate fixation.
The primary outcome measure is to measure the accuracy of the derotation at 12 months by CT scan.
Study design and methodology:
The study is a randomized non-inferiority trail comparing operative treatment of patients with symptomatic increased idiopathic femoral anteversion. There are two arms: (1) Open approach and plating and (2) percutaneous osteotomy and intramedullary nailing. The allocation ratio is 1:1.We will recruit patients in the age 10-18 years of age, referred to the Orthopedic department, Oslo University Hospital. A pediatric orthopedic surgeon will verify that the patient meets the inclusion criteria, and the patient will be given thorough oral and written information. After signed consent, the randomization allocation to treatment method will be performed by means of a web-solution made by NTNU WebCRF system with the approval from the OUS Head of Patient Security.
Follow-up:
The study patients will be followed-up over a one year period (6 weeks, 12 weeks, 12 months). All patients will be tested with 3 d gait analysis at 12 months and will be compared with the patients preoperativ 3 D gait analysis. All reoperations will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Synthes Pediatric LCP Plate System | Active comparator | Device: Pediatric LCP Hip Plate SystemOpen osteotomy and osteofixation with the pediatric LCP hip plate |
| The adolescent Lateral Femoral Nail | Experimental | Device: Adolescent Lateral Entry Femoral NailPercutaneous osteotomy and intramedullary nailing |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Radiographic findings: Femoral AV angle ≥ 30°
- Age 10-18 years.
- Hip or/and knee pain
- Less than 15 degrees external rotation of the hips
Key exclusion criteria (4 listed)
- Patients will be excluded from the study if they meet any of the following criteria:
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 |
|---|---|---|
| Adolescent Lateral Entry Femoral NailThe use of an less invasive implant that has the same accuracy. | Device | The adolescent Lateral Femoral Nail |
| Pediatric LCP Hip Plate SystemOpen approach to the femur where the osteotomy and osteofixation with plate and screws are preformed | Device | The Synthes Pediatric LCP Plate System |
Primary outcome
Accuracy of the derotation
Time frame: post operative (day1)
Accuracy of the derotation measured in degrees on CT comparing the intended/planned correction with the actual derotation
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score for Children (KOOS-Child)
Time frame: Baseline, 26 week and 52 week follow-up
Visual analogue scale
Time frame: Baseline, daily first six week. 4 times a day.
KIDSCREEN-27
Time frame: Baseline, 26 week, 52 week follow-up
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 21 Oct 2026.
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.
Anders Grønseth, M.D principal investigator
Oslo University 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 Adolescent Lateral Entry Femoral Nail and Pediatric LCP Hip Plate System in people with Idiopathic Increased Femoral Anteversion, run by Oslo University Hospital at 1 site in Norway.
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 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: finished, as of the sponsor's last update on 21 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 Norway. 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?
Accuracy of the derotation (time frame: post operative (day1)). 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 21 Oct 2026.