Hallux RigidusNCT07610330
Return to Cross Country Skiing and Other Physical Activities After Arthrodesis of the First Metatarsophalangeal Joint
An observational study of Hallux Rigidus and Hallux Valgus, run by Oslo University Hospital.
Trial summary
Patients who have undergone arthrodesis of the first metatarsophalangeal joint due to hallux valgus or hallux rigidus are invited to participate in this study, which aims to investigate how the foot functions after this operation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Rigidus, Hallux Valgus
- What is being tested?
- Arthrodesis
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2027
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who underwent arthrodesis of the first metatarsophalangeal joint at Oslo University Hospital, Martina Hansens Hospital, or Sørlandet Hospital within the past 1-5 years will be evaluated for enrollment
Who may be able to join
- Patients who has underwent arthrodesis of the first metatarsofalangeal joint because of hallux rigidus or severe hallux valgus
- Patients at age 18-60 at the date of surgery
- At least one year follow-up, and maximum 5 years since surgery.
Who cannot join
- Non-Norwegian-speaking patients.
- Impaired walking function.
- Inability to cooperate.
- Concomitant osteotomy of other metatarsals.
- Revision arthrodeses.
- Patients undergoing follow-up or evaluation for pseudoarthrosis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retur Til Fysisk Aktivitet Etter Avstivning av stortåens Grunnledd
Patients who have undergone arthrodesis of the first metatarsophalangeal joint due to hallux valgus or hallux rigidus are invited to participate in this study, which aims to investigate how the foot functions after this operation. Patients between 18 and 60 years of age at the time of surgery are eligible to participate. Questionnaires will be distributed to assess current sports function compared with function prior to surgery. Particular focus will be placed on function during cross-country skiing.
- Conditions
- Hallux Rigidus, Hallux Valgus
- Being tested
- Arthrodesis
- Keywords
- Return to sport, First metatarsophalangeal joint, Arthrodesis
- Medical subject headings
- Hallux Rigidus, Hallux Valgus, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrodesisProcedure or surgery
Arhtrodesis of the first metatarsophalangeal joint
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to Cross country skiing
Measured: At least 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux RigidusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sorlandet Hospital HF
- Responsible party
- Principal investigator, Andreas Døble, Oslo University Hospital
- Investigators
- Elisabeth Ellingsen Husebye, MD, PhD, Prof., Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610330
- Sponsor's protocol ID
- 980644
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retur Til Fysisk Aktivitet Etter Avstivning av stortåens Grunnledd
- ClinicalTrials.gov ID
- NCT07610330
- Acronym / sponsor ID
- 980644
- Conditions
- Hallux Rigidus, Hallux Valgus
- Keywords
- Return to sport, First metatarsophalangeal joint, Arthrodesis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sorlandet Hospital HF
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 May 2026 (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.
Patients who have undergone arthrodesis of the first metatarsophalangeal joint due to hallux valgus or hallux rigidus are invited to participate in this study, which aims to investigate how the foot functions after this operation. Patients between 18 and 60 years of age at the time of surgery are eligible to participate. Questionnaires will be distributed to assess current sports function compared with function prior to surgery. Particular focus will be placed on function during cross-country skiing.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who underwent arthrodesis of the first metatarsophalangeal joint at Oslo University Hospital, Martina Hansens Hospital, or Sørlandet Hospital within the past 1-5 years will be evaluated for enrollment
Key inclusion criteria (3 listed)
- Patients who has underwent arthrodesis of the first metatarsofalangeal joint because of hallux rigidus or severe hallux valgus
- Patients at age 18-60 at the date of surgery
- At least one year follow-up, and maximum 5 years since surgery.
Key exclusion criteria (6 listed)
- Non-Norwegian-speaking patients.
- Impaired walking function.
- Inability to cooperate.
- Concomitant osteotomy of other metatarsals.
- Revision arthrodeses.
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 |
|---|---|---|
| ArthrodesisArhtrodesis of the first metatarsophalangeal joint | Procedure or surgery | – |
Primary outcome
Return to Cross country skiing
Time frame: At least 1 year after surgery
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 27 May 2026.
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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.
Elisabeth Ellingsen Husebye, MD, PhD, Prof. study director
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Rigidus and Hallux Valgus, run by Oslo University Hospital.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Andreas Døble, MD (004795446020, anddoe@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to Cross country skiing (time frame: At least 1 year after 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 27 May 2026.