Hallux RigidusNCT01804491
Motion Analysis in Patients With Hallux Rigidus
An observational study of Hallux Rigidus, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The aim was to investigate with a multi-segmental foot model the kinetic and kinematic in patients with a hallux rigidus, before and after different type of surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hallux Rigidus
- What is being tested?
- Motion Analysis
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Aug 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with osteoarthritis in the first metatarso-phalangeal joint (hallux rigidus)
Who may be able to join
- patients with osteoarthritis of one or both first metatarso-phalangeal joints (hallux rigidus)
- patients after surgery due to osteoarthritis of one or both first metatarso-phalangeal joints (hallux rigidus)
Who cannot join
- previous operations on the foot and ankle
- rheumatic diseases
- relevant foot deformities other than hallux rigidus
Trial locations and contacts
1 site in 1 country.
Germany1 site
Motion Analysis Laboratory of the Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, University Hospital Heidelberg
Heidelberg, 69118
About this study
Official title: Motion Analysis in Patients With Hallux Rigidus Before and After Different Types of Surgery
The aim was to investigate with a multi-segmental foot model the kinetic and kinematic in patients with a hallux rigidus, before and after different type of surgery.
Read the detailed description
None of the patients received surgery BECAUSE of the study. We have only performed motion analysis in patients, who were already scheduled for one of the described type of surgery (prospective group) or who already previously received one the type of surgery (retrospective group).
- Conditions
- Hallux Rigidus
- Being tested
- Motion Analysis
- Medical subject headings
- Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion AnalysisOther
3D Motion analysis with retroflective markers on the skin (Vicon camera system) of the foot and lower leg (kinematics), walking over force plate (kinetics) and pressure plates (plantar pressure distribution).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Healthy age matched control subjects Receives: Other: Motion Analysis | |
| Cheilectomy prospective group | Patients with hallux rigidus treated by the surgery type "cheilectomy" Receives: Other: Motion Analysis | |
| Arthrodesis prospective group | Patients with hallux rigidus treated by the type of surgery "arthrodesis" Receives: Other: Motion Analysis | |
| Mixed prospective group | Patients with hallux rigidus treated by other type of surgery: Arthoplasty, joint resection ("Keller-Brandes technique) Receives: Other: Motion Analysis | |
| Cheilectomy retrospective group | Patients after cheilectomy due to hallux rigidus Receives: Other: Motion Analysis | |
| Arthrodesis retrospective group | Patients after arthrodesis of the metatarsophalageal joint due to hallux rigidus Receives: Other: Motion Analysis | |
| Mixed retrospective group | Patients after other types of surgery due to hallux rigidus: arthroplasty or resection of the first metatarso-phalangeal joint Receives: Other: Motion Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of hallux range of motion
Measured: baseline (=1 day before surgery) and 1 y. after surgery for the prospective groups, more than one year after surgery for the retrospective groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startOct 2006
- Primary completionAug 2009
- Study completionAug 2009
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 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
- Cohort
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Benita Kuni, MD, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804491
- Sponsor's protocol ID
- 252-2006-130228
- Status last verified
- Mar 2013
- First submitted
- 1 Mar 2013
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuni B, Wolf SI, Zeifang F, Thomsen M. Foot kinematics in walking on a level surface and on stairs in patients with hallux rigidus before and after cheilectomy. J Foot Ankle Res. 2014 Feb 13;7(1):13. doi: 10.1186/1757-1146-7-13.
PubMed 24524773
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Analysis in Patients With Hallux Rigidus Before and After Different Types of Surgery
- ClinicalTrials.gov ID
- NCT01804491
- Acronym / sponsor ID
- 252-2006-130228
- Conditions
- Hallux Rigidus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 5 Mar 2013 (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 aim was to investigate with a multi-segmental foot model the kinetic and kinematic in patients with a hallux rigidus, before and after different type of surgery.
Detailed description
None of the patients received surgery BECAUSE of the study. We have only performed motion analysis in patients, who were already scheduled for one of the described type of surgery (prospective group) or who already previously received one the type of surgery (retrospective group).
Study design
- Observational model
- Cohort
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Motion AnalysisHealthy age matched control subjects |
| Cheilectomy prospective group | – | Other: Motion AnalysisPatients with hallux rigidus treated by the surgery type "cheilectomy" |
| Arthrodesis prospective group | – | Other: Motion AnalysisPatients with hallux rigidus treated by the type of surgery "arthrodesis" |
| Mixed prospective group | – | Other: Motion AnalysisPatients with hallux rigidus treated by other type of surgery: Arthoplasty, joint resection ("Keller-Brandes technique) |
| Cheilectomy retrospective group | – | Other: Motion AnalysisPatients after cheilectomy due to hallux rigidus |
| Arthrodesis retrospective group | – | Other: Motion AnalysisPatients after arthrodesis of the metatarsophalageal joint due to hallux rigidus |
| Mixed retrospective group | – | Other: Motion AnalysisPatients after other types of surgery due to hallux rigidus: arthroplasty or resection of the first metatarso-phalangeal joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoarthritis in the first metatarso-phalangeal joint (hallux rigidus)
Key inclusion criteria (2 listed)
- patients with osteoarthritis of one or both first metatarso-phalangeal joints (hallux rigidus)
- patients after surgery due to osteoarthritis of one or both first metatarso-phalangeal joints (hallux rigidus)
Key exclusion criteria (3 listed)
- previous operations on the foot and ankle
- rheumatic diseases
- relevant foot deformities other than hallux rigidus
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 |
|---|---|---|
| Motion Analysis3D Motion analysis with retroflective markers on the skin (Vicon camera system) of the foot and lower leg (kinematics), walking over force plate (kinetics) and pressure plates (plantar pressure distribution). | Other | Arthrodesis prospective group, Arthrodesis retrospective group, Cheilectomy prospective group, Cheilectomy retrospective group, Control group, Mixed prospective group, Mixed retrospective group |
Primary outcome
Change of hallux range of motion
Time frame: baseline (=1 day before surgery) and 1 y. after surgery for the prospective groups, more than one year after surgery for the retrospective groups
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 5 Mar 2013.
- Derived from this study: PubMed 24524773Kuni B, Wolf SI, Zeifang F, Thomsen M. Foot kinematics in walking on a level surface and on stairs in patients with hallux rigidus before and after cheilectomy. J Foot Ankle Res. 2014 Feb 13;7(1):13. doi: 10.1186/1757-1146-7-13.
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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 Hallux Rigidus, run by University Hospital Heidelberg at 1 site in Germany.
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 5 Mar 2013. 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 Germany. 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?
Change of hallux range of motion (time frame: baseline (=1 day before surgery) and 1 y. after surgery for the prospective groups, more than one year after surgery for the retrospective groups). 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 NCT01804491, 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 5 Mar 2013.