Osteotomy of Lower ExtremityNCT06950047
PediLoc® Blade Plate in Distal Femoral Osteotomies
An observational study of Osteotomy of Lower Extremity, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
Background: The PediLoc® Locking Cannulated Blade Plate System, originally designed for proximal femoral osteotomies, has also been used for multidimensional deformity correction of the distal femur. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteotomy of Lower Extremity
- What is being tested?
- distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System and distal femoral osteotomies using the 90°LCP-PCP
- Type of treatment
- Surgery or procedure
- How many people
- 111 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Mar 2025to 14 Apr 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective study investigated the electronic medical records of patients who underwent distal femoral osteotomy with the Blade Plate system and the 90°LCP-PCP at the University Children's Hospital Zurich between 2020 and 2024.
Who may be able to join
- All Patients that underwent distal femoral osteotomies
- informed consent
Who cannot join
- intraoperative technical error
- missing data
- missing IC
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zürich
Zurich, Canton of Zurich, 8008
About this study
Official title: Application of PediLoc®Locking Cannulated Blade Plate System in Distal Femoral Osteotomies - A Retrospective, Comparative Analysis of Consolidation Rates and Description of the Surgical Technique
Background: The PediLoc® Locking Cannulated Blade Plate System, originally designed for proximal femoral osteotomies, has also been used for multidimensional deformity correction of the distal femur. This study describes the surgical technique and retrospectively analyses consolidation rates of distal femoral osteotomies using this system, comparing them to distal femoral osteotomies using the DePuy Synthes® 90°LCP Pediatric Condylar Plate.
Materials and methods: A retrospective review was conducted for patients who underwent distal femoral osteotomy with the PediLoc® Blade Plate (Blade Plate) and the DePuy Synthes® 90°LCP Pediatric Condylar Plate (90°LCP-PCP) at the University Children's Hospital Zurich (2020-2024). Consolidation rates were assessed using Reborn-, Rust-, and modified Rust-scores at 6 weeks, 3 months, and 6 months postoperatively and compared using an unpaired t-test. Geometric planes of osteotomy were analysed, and a stepwise correction technique was described.
- Conditions
- Osteotomy of Lower Extremity
- Being tested
- distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System, distal femoral osteotomies using the 90°LCP-PCP
- Keywords
- locking plate system, blade plate, distal femoral osteotomy, flexion contracture, deformities, multidimensional osteotomies, pediatric orthopedics, surgical technique
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate SystemProcedure or surgery
distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System
distal femoral osteotomies using the 90°LCP-PCPProcedure or surgery
distal femoral osteotomies using the 90°LCP-PCP
| Study group | Role | What they receive |
|---|---|---|
| distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System | Not described Receives: Procedure: distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System | |
| distal femoral osteotomies using the 90°LCP-PCP | Not described Receives: Procedure: distal femoral osteotomies using the 90°LCP-PCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consolidation rates using Reborn-, Rust- and modified Rust-scores on serial X-ray images
Reborn Score: Minimum: 4pts. maximum 16pts., higher scores are better Rust Score ( Radiographic Union Scale for the Tibia ): Minimum: 4pts. maximum 12pts., higher scores are better modified Rust Score ( Radiographic Union Scale for the Tibia ): Minimum: 4pts. maximum 16pts., higher scores are better
Measured: 6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start28 Mar 2025
- Primary completion14 Apr 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteotomy of Lower ExtremityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Tschudi, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950047
- Sponsor's protocol ID
- 2025-0000
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of PediLoc®Locking Cannulated Blade Plate System in Distal Femoral Osteotomies - A Retrospective, Comparative Analysis of Consolidation Rates and Description of the Surgical Technique
- ClinicalTrials.gov ID
- NCT06950047
- Acronym / sponsor ID
- 2025-0000
- Conditions
- Osteotomy of Lower Extremity
- Keywords
- locking plate system, blade plate, distal femoral osteotomy, flexion contracture, deformities, multidimensional osteotomies, pediatric orthopedics, surgical technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 29 Apr 2025 (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.
Background: The PediLoc® Locking Cannulated Blade Plate System, originally designed for proximal femoral osteotomies, has also been used for multidimensional deformity correction of the distal femur. This study describes the surgical technique and retrospectively analyses consolidation rates of distal femoral osteotomies using this system, comparing them to distal femoral osteotomies using the DePuy Synthes® 90°LCP Pediatric Condylar Plate.
Materials and methods: A retrospective review was conducted for patients who underwent distal femoral osteotomy with the PediLoc® Blade Plate (Blade Plate) and the DePuy Synthes® 90°LCP Pediatric Condylar Plate (90°LCP-PCP) at the University Children's Hospital Zurich (2020-2024). Consolidation rates were assessed using Reborn-, Rust-, and modified Rust-scores at 6 weeks, 3 months, and 6 months postoperatively and compared using an unpaired t-test. Geometric planes of osteotomy were analysed, and a stepwise correction technique was described.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System | – | Procedure: distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System |
| distal femoral osteotomies using the 90°LCP-PCP | – | Procedure: distal femoral osteotomies using the 90°LCP-PCP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective study investigated the electronic medical records of patients who underwent distal femoral osteotomy with the Blade Plate system and the 90°LCP-PCP at the University Children's Hospital Zurich between 2020 and 2024.
Key inclusion criteria (2 listed)
- All Patients that underwent distal femoral osteotomies
- informed consent
Key exclusion criteria (3 listed)
- intraoperative technical error
- missing data
- missing IC
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 |
|---|---|---|
| distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate Systemdistal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System | Procedure or surgery | distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System |
| distal femoral osteotomies using the 90°LCP-PCPdistal femoral osteotomies using the 90°LCP-PCP | Procedure or surgery | distal femoral osteotomies using the 90°LCP-PCP |
Primary outcome
Consolidation rates using Reborn-, Rust- and modified Rust-scores on serial X-ray images
Time frame: 6 weeks, 3 months, 6 months
Reborn Score: Minimum: 4pts. maximum 16pts., higher scores are better Rust Score ( Radiographic Union Scale for the Tibia ): Minimum: 4pts. maximum 12pts., higher scores are better modified Rust Score ( Radiographic Union Scale for the Tibia ): Minimum: 4pts. maximum 16pts., higher scores are better
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 2 May 2025.
- Individual participant dataSharing planned: No
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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.
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?
An observational study of Osteotomy of Lower Extremity, run by University Children's Hospital, Zurich 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 2 inclusion and 3 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 2 May 2025. 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?
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?
Consolidation rates using Reborn-, Rust- and modified Rust-scores on serial X-ray images (time frame: 6 weeks, 3 months, 6 months). 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 2 May 2025.