Adult Acquired FlatfootPhase 4NCT00949897
Comparison Study of Biofoam Porous Metal Versus Allograft to Treat Adult Acquired Flatfoot
A Phase 4 study testing Biofoam and Iliac Crest Allograft with locked plate in people with Adult Acquired Flatfoot, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the clinical and radiographic outcomes of a randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a lateral column lengthening using an allograft bone wedge versus a titanium porous metal implant (Biofoam, Wright Medical). Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Adult Acquired Flatfoot
- What is being tested?
- Biofoam and Iliac Crest Allograft with locked plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2011
- Phase
- Phase 4
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 25-75
- Unresponsive to conservative treatment
- Patient with acquired flatfoot deformity, who is a candidate for lateral column lengthening (Stage IIB) = (greater than > 40% uncoverage of talar head by navicular on standing AP radiograph)
Who cannot join
- Less than 25 years of age and greater than 75 years
- Pre-existing infection
- Peripheral neuropathy
- Charcot arthropathy
- Peripheral vascular disease
- Rhematoid Arthritis (RA) or inflammatory arthropathy
- Metal allergy or sensitivity to metal
Trial locations and contacts
1 site in 1 country.
United States1 site
OrthoCarolina, P.A.
Charlotte, North Carolina, 28203
About this study
Official title: A Randomized, Prospective, Controlled Trial for Lateral Column Lengthening in Adult Acquired Flatfoot Using Biofoam Porous Metal Compared With Allograft
The purpose of this study is to compare the clinical and radiographic outcomes of a randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a lateral column lengthening using an allograft bone wedge versus a titanium porous metal implant (Biofoam, Wright Medical).
Null hypothesis: At six months postoperatively, there is no difference in the degree of correction as measured by the talonavicular coverage angle between patients randomized to allograft and Biofoam.
Alternative hypothesis: At six months postoperatively, the degree of correction as measured by the talonavicular coverage angle will be less in patients randomized to allograft than the degree of correction in patients randomized to Biofoam.
- Conditions
- Adult Acquired Flatfoot
- Being tested
- Biofoam, Iliac Crest Allograft with locked plate
- Keywords
- Adult Acquired Flatfoot, Biofoam Porous Metal Implant, Allograft Bone Wedge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofoamDevice
Also called 510(k) Number: K073535
Device
Iliac Crest Allograft with locked plateOther
Also called Iliac Crest Allograft
| Study group | Role | What they receive |
|---|---|---|
| Biofoam | Active comparator | Not described Receives: Device: Biofoam |
| Iliac Crest Allograft with locked plate | Active comparator | Not described Receives: Other: Iliac Crest Allograft with locked plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of correction as measured by talonavicular coverage angle, which is used to quantify the degree of deformity. Degree of correction is defined as the difference between the preoperative and postoperative talonavicular coverage angle.
Measured: 2 weeks, 6 weeks, 12 weeks, and 6 months
Secondary outcomes (4)
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Measured: 2 weeks, 6 weeks, 3 months, and 6 months
Foot Function Index (FFI) Score
Measured: 2 weeks, 6 weeks, 3 months, and 6 months
Pain Visual Analog Scale (VAS)
Measured: 2 weeks, 6 weeks, 3 months, and 6 months
Implant failure
Measured: 2 weeks, 6 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Funding terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acquired FlatfootStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Trauma and Extremities
- Investigators
- Robert B Anderson, MD, Principal investigator, OrthoCarolina, P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949897
- Sponsor's protocol ID
- 120813B
- Status last verified
- Mar 2013
- First submitted
- 29 Jul 2009
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Controlled Trial for Lateral Column Lengthening in Adult Acquired Flatfoot Using Biofoam Porous Metal Compared With Allograft
- ClinicalTrials.gov ID
- NCT00949897
- Acronym / sponsor ID
- 120813B
- Conditions
- Adult Acquired Flatfoot
- Keywords
- Adult Acquired Flatfoot, Biofoam Porous Metal Implant, Allograft Bone Wedge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Collaborators
- Stryker Trauma and Extremities
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 31 Jul 2009 (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 compare the clinical and radiographic outcomes of a randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a lateral column lengthening using an allograft bone wedge versus a titanium porous metal implant (Biofoam, Wright Medical).
Null hypothesis: At six months postoperatively, there is no difference in the degree of correction as measured by the talonavicular coverage angle between patients randomized to allograft and Biofoam.
Alternative hypothesis: At six months postoperatively, the degree of correction as measured by the talonavicular coverage angle will be less in patients randomized to allograft than the degree of correction in patients randomized to Biofoam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofoam | Active comparator | Device: Biofoam |
| Iliac Crest Allograft with locked plate | Active comparator | Other: Iliac Crest Allograft with locked plate |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 25-75
- Unresponsive to conservative treatment
- Patient with acquired flatfoot deformity, who is a candidate for lateral column lengthening (Stage IIB) = (greater than > 40% uncoverage of talar head by navicular on standing AP radiograph)
Key exclusion criteria (7 listed)
- Less than 25 years of age and greater than 75 years
- Pre-existing infection
- Peripheral neuropathy
- Charcot arthropathy
- Peripheral vascular disease
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 |
|---|---|---|
| BiofoamAlso: 510(k) Number: K073535Device | Device | Biofoam |
| Iliac Crest Allograft with locked plateAlso: Iliac Crest Allograft | Other | Iliac Crest Allograft with locked plate |
Primary outcome
The degree of correction as measured by talonavicular coverage angle, which is used to quantify the degree of deformity. Degree of correction is defined as the difference between the preoperative and postoperative talonavicular coverage angle.
Time frame: 2 weeks, 6 weeks, 12 weeks, and 6 months
4 secondary outcomes
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months
Foot Function Index (FFI) Score
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months
Pain Visual Analog Scale (VAS)
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months
Implant failure
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
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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.
Robert B Anderson, MD principal investigator
OrthoCarolina, P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biofoam and Iliac Crest Allograft with locked plate in people with Adult Acquired Flatfoot, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
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 7 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: withdrawn, as of the sponsor's last update on 13 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The degree of correction as measured by talonavicular coverage angle, which is used to quantify the degree of deformity. Degree of correction is defined as the difference between the preoperative and postoperative talonavicular coverage angle. (time frame: 2 weeks, 6 weeks, 12 weeks, and 6 months). 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 13 Mar 2013; AzTrials last refreshed its copy on 8 Nov 2026.