ClubfootNCT06050564
Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score
An observational study of Clubfoot, run by Region Stockholm at 1 site in Sweden.
Trial summary
Determine the relationship between the PBS-score and treatment recommendations provided by senior pediatric orthopedic surgeons. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Clubfoot
- What is being tested?
- Treatment recommendations will be based on video documented PBS-Score
- How many people
- 55 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2023to 18 Jun 2024
- 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 4 to 14 years
- All sexes
- Child
Study population: 120 children with idiopathic clubfoot will be included from four different countries
Who may be able to join
- diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto.
Who cannot join
- syndromic clubfoot
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Astrid Lindgren Children´s Hospital
Stockholm, Region Stockholm, 17176
About this study
Official title: Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score, an International Cross-sectional Multicenter Study
Determine the relationship between the PBS-score and treatment recommendations provided by senior pediatric orthopedic surgeons.
Read the detailed description
In conjunction with the assessments of video documented PBS-score items (described in Study I), treatment recommendations from six to eight experienced pediatric orthopedic surgeons from four different countries will be collected. Their recommendations will be based on the included items of the PBS-score, and patient history including age of the child, Pirani score, initial treatment (need for tenotomy), and reported compliance to orthotic use.
- Conditions
- Clubfoot
- Being tested
- Treatment recommendations will be based on video documented PBS-Score
- Keywords
- PBS-score, PEVA, Treatment clubfoot
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment recommendations will be based on video documented PBS-ScoreOther
Therapeutic recommendations from orthopedic surgeons, will be summarized and described
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment recommendations
Treatment recommendations from eight to ten experienced pediatric orthopedic surgeons will be collected. Their recommendations will be based on the included items of the Pirani Böhm Sinclair, PBS-score, the lowest score with 7 points being the best and 18 points the worst. The patient history including age of the child, Pirani score minimum 0 and maximum score is 6, the higher, the more severe deformity. Initial treatment (need for Achilles tenotomy), and reported compliance to orthotic use.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start10 Jan 2023
- Primary completion28 Dec 2023
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ClubfootStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eva Weidenhielm-Brostrom, Region Stockholm
- Investigators
- Eva W Broström, Professor, Principal investigator, Astrid Lindgren Children´s Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050564
- Sponsor's protocol ID
- K2022-10587
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thelaus A, Kashif S, Brostrom E, Aroojis A, Frick S, Bohm S, Naili JE. Association between video-based Pirani Bohm Sinclair score and treatment recommendations in recurrent clubfoot in walking-age children. J Orthop Surg Res. 2026 Jul 24;21(1):443. doi: 10.1186/s13018-026-07122-6.
PubMed 42498950
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score, an International Cross-sectional Multicenter Study
- ClinicalTrials.gov ID
- NCT06050564
- Acronym / sponsor ID
- K2022-10587
- Conditions
- Clubfoot
- Keywords
- PBS-score, PEVA, Treatment clubfoot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 22 Sep 2023 (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.
Determine the relationship between the PBS-score and treatment recommendations provided by senior pediatric orthopedic surgeons.
Detailed description
In conjunction with the assessments of video documented PBS-score items (described in Study I), treatment recommendations from six to eight experienced pediatric orthopedic surgeons from four different countries will be collected. Their recommendations will be based on the included items of the PBS-score, and patient history including age of the child, Pirani score, initial treatment (need for tenotomy), and reported compliance to orthotic use.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- 120 children with idiopathic clubfoot will be included from four different countries
Key inclusion criteria (1 listed)
- diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto.
Key exclusion criteria (1 listed)
- syndromic clubfoot
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 |
|---|---|---|
| Treatment recommendations will be based on video documented PBS-ScoreTherapeutic recommendations from orthopedic surgeons, will be summarized and described | Other | – |
Primary outcome
Treatment recommendations
Time frame: 1 year
Treatment recommendations from eight to ten experienced pediatric orthopedic surgeons will be collected. Their recommendations will be based on the included items of the Pirani Böhm Sinclair, PBS-score, the lowest score with 7 points being the best and 18 points the worst. The patient history including age of the child, Pirani score minimum 0 and maximum score is 6, the higher, the more severe deformity. Initial treatment (need for Achilles tenotomy), and reported compliance to orthotic use.
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 15 Sep 2025.
- Derived from this study: PubMed 42498950Thelaus A, Kashif S, Brostrom E, Aroojis A, Frick S, Bohm S, Naili JE. Association between video-based Pirani Bohm Sinclair score and treatment recommendations in recurrent clubfoot in walking-age children. J Orthop Surg Res. 2026 Jul 24;21(1):443. doi: 10.1186/s13018-026-07122-6.
- 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.
Eva W Broström, Professor principal investigator
Astrid Lindgren Children´s Hospital
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 Clubfoot, run by Region Stockholm at 1 site in Sweden.
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 1 inclusion and 1 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 15 Sep 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 Sweden. 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?
Treatment recommendations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06050564, which also lists 1 linked publication.
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 15 Sep 2025.