Hallux RigidusNCT02904447
Plantar Forces Mid-term After Hemiarthroplasty With HemiCap for Hallux Rigidus
An observational study of Hallux Rigidus, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
The purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th toes and the metatarsal distal caput in patients who have had surgery with a partial proximal hemiarthroplasty in the 1st metatarsalphalangeal joint (MTP) between 2006-2014. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hallux Rigidus
- What is being tested?
- x-ray and pedobar foot pressure mapping
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Feb 2017
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patient who has had an operation with proximal hemiarthroplasty (hemicap) 1st MTP proximal prosthetics 2006-2014 in Hvidovre Hospital, Glostrup Hospital or Hamlet-Aleris Hospital.
Who may be able to join
- patients who has hemicap 1. MTP joint.
Who cannot join
- patients who haad revision surgery, for example removal of hemicap and desis og 1. MTP joint.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th toes and the metatarsal distal caput in patients who have had surgery with a partial proximal hemiarthroplasty in the 1st metatarsalphalangeal joint (MTP) between 2006-2014.
Also, to examine these variables and compare them to the totalt range of motion and pain, to find out if the measured pedobar pressure can be used identify the well treated patient and the poorly treated patient.
The pedobar pressure gradients will be compared with a control group with healthy feet.
- Conditions
- Hallux Rigidus
- Being tested
- x-ray and pedobar foot pressure mapping
- Keywords
- hemicap, hallux rigidus
- Medical subject headings
- Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x-ray and pedobar foot pressure mappingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar forces under the hallux and the forefoot in patients operated with a hemiCAP in the 1st MTPJ.
Plantar forces are measured under the hallux and the forefoot (plantar pressure (kPa), maximal force (N), and force/time (N/s)) is measured by the Emed foot pressure mapping system.
Measured: One examination for each patient, approximately 30 min.
Secondary outcomes (2)
Range of motion (degrees)
Unit: degrees. ROM of the hemicap operated 1st MTPJ
Measured: One examination for each patient, approximately 30 min.
Level of pain
Visual analog scale, 1-10 of the hemicap operated foot
Measured: One examination for each patient, approximately 30 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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.
- 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
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pernille Henszelman Jørsboe, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904447
- Sponsor's protocol ID
- HEMICAP
- Status last verified
- Nov 2017
- First submitted
- 19 Jul 2016
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Forces Mid-term After Hemiarthroplasty With HemiCap for Hallux Rigidus
- ClinicalTrials.gov ID
- NCT02904447
- Acronym / sponsor ID
- HEMICAP
- Conditions
- Hallux Rigidus
- Keywords
- hemicap, hallux rigidus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
The purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th toes and the metatarsal distal caput in patients who have had surgery with a partial proximal hemiarthroplasty in the 1st metatarsalphalangeal joint (MTP) between 2006-2014.
Also, to examine these variables and compare them to the totalt range of motion and pain, to find out if the measured pedobar pressure can be used identify the well treated patient and the poorly treated patient.
The pedobar pressure gradients will be compared with a control group with healthy feet.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who has had an operation with proximal hemiarthroplasty (hemicap) 1st MTP proximal prosthetics 2006-2014 in Hvidovre Hospital, Glostrup Hospital or Hamlet-Aleris Hospital.
Key inclusion criteria (1 listed)
- patients who has hemicap 1. MTP joint.
Key exclusion criteria (1 listed)
- patients who haad revision surgery, for example removal of hemicap and desis og 1. MTP joint.
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 |
|---|---|---|
| x-ray and pedobar foot pressure mapping | Other | – |
Primary outcome
Plantar forces under the hallux and the forefoot in patients operated with a hemiCAP in the 1st MTPJ.
Time frame: One examination for each patient, approximately 30 min.
Plantar forces are measured under the hallux and the forefoot (plantar pressure (kPa), maximal force (N), and force/time (N/s)) is measured by the Emed foot pressure mapping system.
2 secondary outcomes
Range of motion (degrees)
Time frame: One examination for each patient, approximately 30 min.
Level of pain
Time frame: One examination for each patient, approximately 30 min.
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 28 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Hallux Rigidus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Recruiting
Kinetic Control Versus Dynamic Taping on First Metatarsophalangeal Joint in Athletes With Functional Hallux Limitus
Hallux Limitus
Not yet recruitingObservational study
Return to Cross Country Skiing and Other Physical Activities After Arthrodesis of the First Metatarsophalangeal Joint
Hallux Rigidus, Hallux Valgus
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
Not yet recruiting
Effect of Foot Core Control Training on Dorsiflexion Function and Gait Biomechanical Characteristics of Patients With Chronic Plantar Fasciitis
Chronic Plantar Fasciitis, Functional Hallux Limitus
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 Hallux Rigidus, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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 28 Nov 2017. 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 Denmark. 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?
Plantar forces under the hallux and the forefoot in patients operated with a hemiCAP in the 1st MTPJ. (time frame: One examination for each patient, approximately 30 min.). 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 28 Nov 2017.