Hallux ValgusMini3DNCT05082012
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
A study testing Treatment of Hallux Valgus in people with Hallux Valgus and Bunion, run by Treace Medical Concepts, Inc. at 10 sites in United States.
Trial summary
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery. Up to 200 subjects will be treated in this study at up to 20 clinical sites. Read more about this study
- Who is it for?
- Ages 14 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus, Bunion
- What is being tested?
- Treatment of Hallux Valgus
- Type of treatment
- Medical device
- How many people
- 123 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Sep 2021to 9 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 58 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:
- Male and females between the ages 14 and 58 years at the time of consent;
- Closed physeal plates at the time of consent;
- Intermetatarsal angle is between 10.0˚ - 22.0˚;
- Hallux valgus angle is between 16.0˚ - 40.0˚;
- Willing and able to adhere to early weight-bearing instructions post-operatively;
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- Capable of completing self-administered questionnaires;
- Acceptable surgical candidate, including use of general anesthesia;
- Female patients must be of non-child bearing potential or have a negative pregnancy test within 7 days prior to index procedure;
- Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits;
- Willing and able to provide written informed consent.
Who cannot join
- Patients satisfying the following criteria will not be eligible for participation:
- Previous surgery for hallux valgus on operative side;
- Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe or lesser toes/digits);
- Additional concomitant procedures outside of the 1st ray;
- Moderate or Severe osteoarthritis of the MTP joint based on radiographic imaging (including lack of evident crista) or positive grind test;
- Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination <5˚and talonavicular subluxation/uncovering >50%);
Show all 28Show fewer
- BMI >40 kg/m²;
- Current nicotine user, including current use of nicotine patch;
- Current clinical diagnosis of diabetes with fasting plasma glucose > 126 mg/dL and/or HbA1c ≥7.0;
- Current clinical diagnosis of peripheral neuropathy or by assessment on 4-point monofilament test;
- Current clinical diagnosis of fibromyalgia;
- Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD);
- Current uncontrolled hypothyroidism;
- Previously sensitized to titanium;
- Currently taking oral steroids or rheumatoid biologics;
- Currently taking immunosuppressant drugs;
- Insufficient quantity or quality of bone to permit stabilization, conditions that retard healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease;
- Active, suspected or latent infection in the affected area;
- Use of synthetic or allogenic bone graft substitutes;
- Current diagnosis of metatarsus adductus (defined as MAA ≥ 23˚);
- Known keloid and hypertrophic scar forming;
- Scheduled to undergo a same-day bilateral procedure. Patient agrees to refrain from the Lapiplasty® Procedure (or other hallux valgus procedures) on contralateral foot for minimum of 6 months post index procedure;
- Patient has previously been enrolled into this study for a contralateral procedure;
- Scheduled for any concomitant procedure that would alter patient's ability to early weight-bear post-procedure;
- Patient requires an incision >4.0 cm to complete the procedure (determined pre-operatively or intra-operatively);
- Patient is actively involved with a workman's compensation case or is currently involved in litigation;
- Patient is currently or has participated in a clinical study in the last 30 days prior to signing informed consent or is considering participation in another research protocol during this study. Exceptions to this include survey clinical studies with no treatment or if subject is greater than 12 months post procedure in the Treace ALIGN3D™ study without ongoing protocol defined AE; these are not exclusionary;
- Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the patient's well-being, the soundness of this clinical study, or could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
DOC - Decatur Orthopaedic Clinic
Decatur, Alabama, 35601
Stonebriar Foot and Ankle
Frisco, Texas, 75034
DOC - Decatur Orthopaedic Clinic
Hartselle, Alabama, 35640
JCMG - Podiatry
Jefferson City, Missouri, 65109
Foot & Ankle Associates of North Texas - Keller
Keller, Texas, 76248
Desert Orthopaedic Center
Las Vegas, Nevada, 89121
Orlando Foot and Ankle Clinic - Waterford Lakes Office
Orlando, Florida, 32825
University of Pennsylvania / Penn Medicine
Philadelphia, Pennsylvania, 19106
Sports Medicine Associates of San Antonio
San Antonio, Texas, 78240
Phoenix Foot and Ankle Institute
Scottsdale, Arizona, 85251
About this study
Official title: Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesis With Early Weight-Bearing After Lapiplasty® ProceDure Through a Mini-Incision™ Approach (Mini3D)
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery.
Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
Read the detailed description
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery:
- To determine radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure.
- To determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes.
- To assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction.
- To evaluate the quality of life and pain scores following the Lapiplasty® Procedure.
- Conditions
- Hallux Valgus, Bunion
- Being tested
- Treatment of Hallux Valgus
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of Hallux ValgusDevice
Also called Lapiplasty® Mini-Incision™ Procedure
Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated subject duration will be 2 years post index procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Recurrence
Radiographic recurrence of hallux valgus deformity at 24 months for subjects with successful correction (defined as Intermetatarsal Angle (IMA) <9.0°, Hallux Valgus Angle (HVA)<15.0° and Tibial Sesamoid Position (TSP) as ≤ 3 at 6 weeks post-Lapiplasty® Procedure). Recurrence is defined by any two of the following three criteria being met at 24 months post-procedure: IMA of ≥12°, HVA ≥20° and TSP ≥4
Measured: 24 months
Secondary outcomes (16)
Radiographic Angular Measurements
Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure [Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure].
Measured: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Number Of Patients With Radiographic Non-Union
Union vs non-union -- Non-union defined as lucency at TMT joint, hardware failure and/or loss of correction, plus clinical pain at first TMT joint
Measured: 12 months post Lapiplasty® Procedure
Clinical Complications Due to Lapiplasty® System Implants, the Procedure, the Post-op Weight-bearing Protocol or Health Conditions That Could Affect Other Outcome Measures - Measured by Adverse Events and Product Complaint Data
Clinical complications due to Lapiplasty® System Implants, the procedure, the post-op weight-bearing protocol or health conditions that could affect other outcome measures - measured by Adverse Events and Product Complaint data
Measured: 24 months post Lapiplasty® Procedure
Time to Start Weight-bearing in a Boot, in Days
Time to start weight-bearing in a boot, in days
Measured: 0-3 weeks, post Lapiplasty® Procedure
Time to Start Weight-bearing in a Shoe
Time to start weight-bearing in a shoe
Measured: From time of procedure up to 6 weeks
Time to Return to Full Unrestricted Activity, in Days
Time to return to full unrestricted activity, in days
Measured: From time of procedure up to 4 months
Change in Pain
Change in pain assess via Visual Analog Scale (VAS), scale values 0-10, 0 indicates no pain and 10 indicates the worse possible pain. Assessed at 0-2 weeks, 2-3 weeks, 6 weeks, 4 months, 6 months, 12 months, and 24 months post Lapiplasty® Procedure, 6 weeks, 4 months, 6 months, 12 months, and 24 months reported.
Measured: 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Change in Range of Motion
1st MTP dorsiflexion and plantarflexion
Measured: 12 months, 24 months post Lapiplasty® Procedure
Change in PROMIS - Quality of Life Score
Each question has five response categories ranging in value from 1 to 5. The min and max response within each question is 1 and 5, respectively. The total raw score is calculated as the sum of the values of the responses to each question. The total raw score is then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Higher scores within the Physical Function and the Ability to Participate in Social Roles/Activities domains indicate better patient-reported health status. Lower scores within the Anxiety, Depression, Fatigue, Pain Interference, Sleep Disturbance, and Pain Intensity indicate better patient-reported health status.
Measured: 6 months, 12 months, 24 months post Lapiplasty® Procedure
Change in Quality of Life - MOxFQ
This instrument has 16 questions, each question has 5 response categories with scoring 0 to 4 where 0 represents the least problems and 4 represents greatest problems. The min and max response within each question is 0 and 4, respectively. The maximum possible raw score for the Walking/Standing domain is 28. The maximum possible raw score for the Pain domain is 20. The maximum possible raw score for the Social Interaction domain is 16. Scores for each domain are calculated separately, as the sum of each individual item (raw) score within that domain. In each case, this is then converted to a metric of 0 - 100 (higher score representing greater severity). Scores for the MOXFQ Index are initially calculated as the sum of all 16 individual item (raw) scores (maximum possible raw score 64). This is then converted to a metric of 0 - 100 (higher score representing greater severity).
Measured: 6 months, 12 months, 24 months post Lapiplasty® Procedure
Change in Radiographic Foot Length
Change in radiographic foot length compared to baseline visit.
Measured: 12 months post Lapiplasty® Procedure
Change in Radiographic Foot Width
Change in radiographic foot width (mm) compared to baseline visit
Measured: 12 months post Lapiplasty® Procedure
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Change in swelling as compared to 0-14 day visit.
Measured: 6 weeks and 4 months post Lapiplasty® Procedure
Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)
Change in scar quality in comparison to baseline visit. 1 equals the lowest score indicating normal skin to 10 the highest score indicating largest difference from normal skin of the 6 components on the scale. Total score can range from 6 to 60 by calculating the sum of all 6 components.
Measured: 4 months, 6 months, and 12 months post Lapiplasty® Procedure
Change in Tibial Sesamoid Position (TSP)
Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure [Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure].
Tibial Sesamoid Position (TSP) was graded from 1-7 and defined as the position of the medial sesamoid in relation to the longitudinal anatomic axis of the first metatarsal on AP radiographs based on the Hardy and Clapham classification. Lower TSP values (<4) represent anatomic sesamoid reduction and triplanar correction. The importance of sesamoid reduction in maintenance of correction and patient outcomes has been published.
Measured: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Change in Osseous Foot Width (OFW)
Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure [Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure].
Measured: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start17 Sep 2021
- Primary completion9 May 2024
- Study completion9 May 2024
Why it stopped: Corporate decision to early term study to prepare for publication and addition of new studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hallux ValgusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treace Medical Concepts, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jody McAleer, DPM, FACFAS, Principal investigator, JCMG - Podiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082012
- Sponsor's protocol ID
- CP2021-1
- Acronym
- Mini3D
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2021
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesis With Early Weight-Bearing After Lapiplasty® ProceDure Through a Mini-Incision™ Approach (Mini3D)
- ClinicalTrials.gov ID
- NCT05082012
- Acronym / sponsor ID
- Mini3D / CP2021-1
- Conditions
- Hallux Valgus, Bunion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corporate decision to early term study to prepare for publication and addition of new studies
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Treace Medical Concepts, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Posted 20 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery.
Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
Detailed description
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery:
- To determine radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure.
- To determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes.
- To assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction.
- To evaluate the quality of life and pain scores following the Lapiplasty® Procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:
- Male and females between the ages 14 and 58 years at the time of consent;
- Closed physeal plates at the time of consent;
- Intermetatarsal angle is between 10.0˚ - 22.0˚;
- Hallux valgus angle is between 16.0˚ - 40.0˚;
Key exclusion criteria (28 listed)
- Previous surgery for hallux valgus on operative side;
- Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe or lesser toes/digits);
- Additional concomitant procedures outside of the 1st ray;
- Moderate or Severe osteoarthritis of the MTP joint based on radiographic imaging (including lack of evident crista) or positive grind test;
- Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination <5˚and talonavicular subluxation/uncovering >50%);
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 |
|---|---|---|
| Treatment of Hallux ValgusAlso: Lapiplasty® Mini-Incision™ ProcedurePatients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated subject duration will be 2 years post index procedure. | Device | – |
Primary outcome
Radiographic Recurrence
Time frame: 24 months
Radiographic recurrence of hallux valgus deformity at 24 months for subjects with successful correction (defined as Intermetatarsal Angle (IMA) <9.0°, Hallux Valgus Angle (HVA)<15.0° and Tibial Sesamoid Position (TSP) as ≤ 3 at 6 weeks post-Lapiplasty® Procedure). Recurrence is defined by any two of the following three criteria being met at 24 months post-procedure: IMA of ≥12°, HVA ≥20° and TSP ≥4
16 secondary outcomes
Radiographic Angular Measurements
Time frame: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Number Of Patients With Radiographic Non-Union
Time frame: 12 months post Lapiplasty® Procedure
Clinical Complications Due to Lapiplasty® System Implants, the Procedure, the Post-op Weight-bearing Protocol or Health Conditions That Could Affect Other Outcome Measures - Measured by Adverse Events and Product Complaint Data
Time frame: 24 months post Lapiplasty® Procedure
Time to Start Weight-bearing in a Boot, in Days
Time frame: 0-3 weeks, post Lapiplasty® Procedure
Time to Start Weight-bearing in a Shoe
Time frame: From time of procedure up to 6 weeks
Time to Return to Full Unrestricted Activity, in Days
Time frame: From time of procedure up to 4 months
Change in Pain
Time frame: 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Change in Range of Motion
Time frame: 12 months, 24 months post Lapiplasty® Procedure
Change in PROMIS - Quality of Life Score
Time frame: 6 months, 12 months, 24 months post Lapiplasty® Procedure
Change in Quality of Life - MOxFQ
Time frame: 6 months, 12 months, 24 months post Lapiplasty® Procedure
Change in Radiographic Foot Length
Time frame: 12 months post Lapiplasty® Procedure
Change in Radiographic Foot Width
Time frame: 12 months post Lapiplasty® Procedure
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Time frame: 6 weeks and 4 months post Lapiplasty® Procedure
Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 4 months, 6 months, and 12 months post Lapiplasty® Procedure
Change in Tibial Sesamoid Position (TSP)
Time frame: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Change in Osseous Foot Width (OFW)
Time frame: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jody McAleer, DPM, FACFAS principal investigator
JCMG - Podiatry
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of Hallux Valgus in people with Hallux Valgus and Bunion, run by Treace Medical Concepts, Inc. at 10 sites 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 11 inclusion and 28 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: stopped early, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Radiographic Recurrence (time frame: 24 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 20 Apr 2026.