Flat FootNCT03421665
Evaluation of the Titan 3-D™ Wedge System
An observational study of Flat Foot and Lateral Column Lengthening, run by Paragon 28.
Trial summary
Evaluate clinical healing and radiographic maintenance of correction following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Flat Foot, Lateral Column Lengthening, Medial Cuneiform Osteotomy
- What is being tested?
- Titan 3D Wedge System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2018to 1 Sep 2022
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include males and females of all ages. Furthermore, it is likely that the majority of subjects enrolled in this study suffer from a flatfoot deformity; however, this study will not be restricted to only those diagnosed with flatfoot.
Who may be able to join
- The subject has foot pain/discomfort on the foot in question.
- The subject has activity limitations due to the foot in question.
- The subject agrees to comply with the requirements of the study and complete the study measures.
- The subject (or representative of the subject in the case of a minor) is willing and able to provide written informed consent.
- The subject plans on undergoing an LCL procedure and/or medial cuneiform osteotomy with a TITAN 3-D™ Wedge.
Who cannot join
- The subject is pregnant.
- The subject had been previously sensitized to titanium.
- The subject is scheduled for a same day bilateral LCL procedure or medial cuneiform osteotomy procedure.
- The subject is not expected to complete the study according to the investigation plan.
- The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
- The subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs or anticipated to be non-compliant.
About this study
Official title: A Multicenter, Prospective, Post-Market Clinical Follow-Up Evaluation of the Titan 3-D™ Wedge System
Evaluate clinical healing and radiographic maintenance of correction following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Subjects who receive one or more TITAN 3-D™ Wedges will obtain satisfactory levels of clinical healing and radiographic maintenance of correction at 6 months.
- Being tested
- Titan 3D Wedge System
- Keywords
- titanium wedge, Evans, Cotton
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titan 3D Wedge SystemDevice
Each subject will undergo an LCL procedure and/or medial cuneiform osteotomy with one or more TITAN 3-D™ Wedges. Ancillary fixation should be used in conjunction with each TITAN 3-D™ Wedge used. This surgical procedure will be performed as standard of care and is not part of the research procedures. Post-operative care and weight-bearing/activity restrictions will be at the discretion of the surgeon as part of their standard of care for the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Titan 3-D Wedge System | Subjects who receive one or more Titan 3D wedge(s). Receives: Device: Titan 3D Wedge System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Healing
Evaluate clinical healing following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Clinical healing is defined as lack of pain over the osteotomy site.
Measured: 6 Months
Radiographic Maintenance of Correction
Evaluate radiographic maintenance of correction following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Radiographic maintenance of correction is defined as the absence of a clinically relevant change in radiographic measures across post-operative time points.
Measured: 6 Months
Secondary outcomes (13)
Time to clinical/radiographic healing (union)
Evaluate time to clinical/radiographic healing (union vs. non-union) after a Titan 3D wedge procedure
Measured: 24 Months
Clinical complications
Complications due to the procedure
Measured: 24 Months
Maintenance of implant position
Measured: 24 Months
Maintenance of anatomical alignment
Measured: 24 Months
Determine bone reaction, if any, to the device such as overgrowth or cystic lesions
Measured: 24 Months
Determine rate of removal of the device and subsequent healing
Measured: 24 Months
Change in anatomical and radiographic angular/positional alignment before and after an LCL procedure and/or medial cuneiform osteotomy using a TITAN 3-D™ Wedge
Measured: 24 Months
Change in VAS Pain Score across multiple time points
Visual Analog Scale (VAS). Line from 0 (no pain) to 10 (worst pain). Patient reported.
Measured: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in AOFAS Ankle-Hindfoot and/or Midfoot Score across multiple time points
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot clinical score.
Pain: 0-40 points Function: 0-50 points Alignment: 0-10 points Total Score (sum): 0-100 points (higher score indicates better outcomes)
American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot clinical score. Pain: 0-40 points Function: 0-45 points Alignment: 0-15 points Total Score (sum): 0-100 points (higher score indicates better outcomes)
Measured: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Pain Intensity Score across multiple time points
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score, Item Bank v1.0, SF 3a.
Raw Score Range: 3 (no pain) to 15 (very severe pain)
Measured: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Mobility Score across multiple time points
Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility Score, Item Bank v2.0.
Raw Score Range: 15 (high level of difficulty) to 120 (no difficulty)
Measured: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Pain Interference Score across multiple time points
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score, Item Bank v1.0, SF 6a.
Raw Score Range: 6 (no interference) to 30 (high level of interference)
Measured: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Compare the outcomes and complication rates of TITAN 3-D™ Wedges with previously published outcomes of historical controls, allograft bone and autograft bone
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start15 Jun 2018 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: Sponsor decided to pursue an alternative study prior to subject enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat FootStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paragon 28
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421665
- Sponsor's protocol ID
- P03-SP-0001
- Status last verified
- Oct 2018
- First submitted
- 29 Jan 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Post-Market Clinical Follow-Up Evaluation of the Titan 3-D™ Wedge System
- ClinicalTrials.gov ID
- NCT03421665
- Acronym / sponsor ID
- P03-SP-0001
- Keywords
- titanium wedge, Evans, Cotton
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decided to pursue an alternative study prior to subject enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Paragon 28Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2018 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 5 Feb 2018 (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.
Evaluate clinical healing and radiographic maintenance of correction following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Subjects who receive one or more TITAN 3-D™ Wedges will obtain satisfactory levels of clinical healing and radiographic maintenance of correction at 6 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Titan 3-D Wedge System | – | Device: Titan 3D Wedge SystemSubjects who receive one or more Titan 3D wedge(s). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include males and females of all ages. Furthermore, it is likely that the majority of subjects enrolled in this study suffer from a flatfoot deformity; however, this study will not be restricted to only those diagnosed with flatfoot.
Key inclusion criteria (5 listed)
- The subject has foot pain/discomfort on the foot in question.
- The subject has activity limitations due to the foot in question.
- The subject agrees to comply with the requirements of the study and complete the study measures.
- The subject (or representative of the subject in the case of a minor) is willing and able to provide written informed consent.
- The subject plans on undergoing an LCL procedure and/or medial cuneiform osteotomy with a TITAN 3-D™ Wedge.
Key exclusion criteria (6 listed)
- The subject is pregnant.
- The subject had been previously sensitized to titanium.
- The subject is scheduled for a same day bilateral LCL procedure or medial cuneiform osteotomy procedure.
- The subject is not expected to complete the study according to the investigation plan.
- The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
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 |
|---|---|---|
| Titan 3D Wedge SystemEach subject will undergo an LCL procedure and/or medial cuneiform osteotomy with one or more TITAN 3-D™ Wedges. Ancillary fixation should be used in conjunction with each TITAN 3-D™ Wedge used. This surgical procedure will be performed as standard of care and is not part of the research procedures. Post-operative care and weight-bearing/activity restrictions will be at the discretion of the surgeon as part of their standard of care for the procedure. | Device | Titan 3-D Wedge System |
Primary outcome
Clinical Healing
Time frame: 6 Months
Evaluate clinical healing following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Clinical healing is defined as lack of pain over the osteotomy site.
Radiographic Maintenance of Correction
Time frame: 6 Months
Evaluate radiographic maintenance of correction following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Radiographic maintenance of correction is defined as the absence of a clinically relevant change in radiographic measures across post-operative time points.
13 secondary outcomes
Time to clinical/radiographic healing (union)
Time frame: 24 Months
Clinical complications
Time frame: 24 Months
Maintenance of implant position
Time frame: 24 Months
Maintenance of anatomical alignment
Time frame: 24 Months
Determine bone reaction, if any, to the device such as overgrowth or cystic lesions
Time frame: 24 Months
Determine rate of removal of the device and subsequent healing
Time frame: 24 Months
Change in anatomical and radiographic angular/positional alignment before and after an LCL procedure and/or medial cuneiform osteotomy using a TITAN 3-D™ Wedge
Time frame: 24 Months
Change in VAS Pain Score across multiple time points
Time frame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in AOFAS Ankle-Hindfoot and/or Midfoot Score across multiple time points
Time frame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Pain Intensity Score across multiple time points
Time frame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Mobility Score across multiple time points
Time frame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Pain Interference Score across multiple time points
Time frame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Compare the outcomes and complication rates of TITAN 3-D™ Wedges with previously published outcomes of historical controls, allograft bone and autograft bone
Time frame: 24 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 15 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Flat Foot and Lateral Column Lengthening, run by Paragon 28.
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 5 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: withdrawn, as of the sponsor's last update on 15 Oct 2018. 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?
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?
Clinical Healing (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 15 Oct 2018.