Charcot NeuroarthropathyNCT01770639
A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy
An observational study of Charcot Neuroarthropathy and Diabetic Foot, run by AO Clinical Investigation and Publishing Documentation at 3 sites in Germany.
Trial summary
The aim of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Charcot Neuroarthropathy, Diabetic Foot
- What is being tested?
- MFB
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2013to May 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neuro-osteoarthropathy of the foot or with other neurological impairment in combination with foot deformity who have previously undergone surgical reconstruction of the midfoot with the Midfoot Fusion Bolt.
Who may be able to join
- Age ≥ 18 at date of inclusion
- Previous surgical reconstruction of the midfoot with Midfoot Fusion Bolt(s) for one of the following indications:
- Neuroarthropathy Deformity of the foot with neurological impairment - Signed informed consent according to local regulation
Who cannot join
- Prisoner at date of inclusion
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Universitätsklinikum Dresden
Dresden
Universität Rostock
Rostock
Klinik für Fuss und Sprunggelenkchirurgie Rummelsberg
Rummelsberg
About this study
The aim of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot.
- Conditions
- Charcot Neuroarthropathy, Diabetic Foot
- Being tested
- MFB
- Keywords
- charcot foot, charcot neuroarthropathy, midfoot arthrodesis, midfoot fusion
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MFBProcedure or surgery
Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)
| Study group | Role | What they receive |
|---|---|---|
| MFB | Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB) Receives: Procedure: MFB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure within the first year after surgery
The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first year after surgery.
Measured: Date of surgery to 1 year posto-op
Secondary outcomes (5)
Treatment failure within the first two years after surgery
The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first two years after surgery.
Measured: Date of surgery to 2 years post-op
Adverse events related to the treatment or device under investigation
The occurrence, type, and date of adverse events related to the midfoot arthrodesis or the MFB within the first two years after surgery.
Measured: Date of surgery to 2 years post-op
Immobilization and non-weightbearing
The duration and type of postoperative immobilization and the duration of postoperative non-weightbearing.
Measured: Date of surgery to time of full weightbearing
Surgery details
Technical details of the midfoot reconstruction surgery .
Measured: Date of surgery
Foot angles
Talus-first metatarsal angle and calcaneus-fifth metatarsal angle on the AP and lateral x-rays of the affected foot before surgery, immediately after surgery, 6 weeks, 12 weeks, 6 months, and 12 months after surgery.
Measured: Pre-op, post-op, 6w, 12w, 6m, 12m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionMay 2014
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 Charcot NeuroarthropathyStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770639
- Sponsor's protocol ID
- MFB Retro
- Status last verified
- Jun 2014
- First submitted
- 16 Jan 2013
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Richter M, Mittlmeier T, Rammelt S, Agren PH, Hahn S, Eschler A. Intramedullary fixation in severe Charcot osteo-neuroarthropathy with foot deformity results in adequate correction without loss of correction - Results from a multi-centre study. Foot Ankle Surg. 2015 Dec;21(4):269-76. doi: 10.1016/j.fas.2015.02.003. Epub 2015 Mar 9.
PubMed 26564730
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy
- ClinicalTrials.gov ID
- NCT01770639
- Acronym / sponsor ID
- MFB Retro
- Conditions
- Charcot Neuroarthropathy, Diabetic Foot
- Keywords
- charcot foot, charcot neuroarthropathy, midfoot arthrodesis, midfoot fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Jan 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 of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MFB | – | Procedure: MFBSurgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neuro-osteoarthropathy of the foot or with other neurological impairment in combination with foot deformity who have previously undergone surgical reconstruction of the midfoot with the Midfoot Fusion Bolt.
Key inclusion criteria (3 listed)
- Age ≥ 18 at date of inclusion
- Previous surgical reconstruction of the midfoot with Midfoot Fusion Bolt(s) for one of the following indications:
- Neuroarthropathy Deformity of the foot with neurological impairment - Signed informed consent according to local regulation
Key exclusion criteria (1 listed)
- Prisoner at date of inclusion
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 |
|---|---|---|
| MFBSurgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB) | Procedure or surgery | MFB |
Primary outcome
Treatment failure within the first year after surgery
Time frame: Date of surgery to 1 year posto-op
The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first year after surgery.
5 secondary outcomes
Treatment failure within the first two years after surgery
Time frame: Date of surgery to 2 years post-op
Adverse events related to the treatment or device under investigation
Time frame: Date of surgery to 2 years post-op
Immobilization and non-weightbearing
Time frame: Date of surgery to time of full weightbearing
Surgery details
Time frame: Date of surgery
Foot angles
Time frame: Pre-op, post-op, 6w, 12w, 6m, 12m
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 25 Jun 2014.
- Derived from this study: PubMed 26564730Richter M, Mittlmeier T, Rammelt S, Agren PH, Hahn S, Eschler A. Intramedullary fixation in severe Charcot osteo-neuroarthropathy with foot deformity results in adequate correction without loss of correction - Results from a multi-centre study. Foot Ankle Surg. 2015 Dec;21(4):269-76. doi: 10.1016/j.fas.2015.02.003. Epub 2015 Mar 9.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Charcot Neuroarthropathy and Diabetic Foot, run by AO Clinical Investigation and Publishing Documentation at 3 sites 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 3 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 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Treatment failure within the first year after surgery (time frame: Date of surgery to 1 year posto-op). 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 NCT01770639, 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 25 Jun 2014.