Bunion, Hallux Valgus
Conditions
Brief 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. 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: 1. To determine radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure. 2. To determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes. 3. To assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction. 4. To evaluate the quality of life and pain scores following the Lapiplasty® Procedure.
Interventions
DEVICETreatment of Hallux Valgus
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.
Sponsors
Treace Medical Concepts, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 58 Years
Healthy volunteers
Yes
Inclusion criteria
Patients satisfying the following criteria will be considered the screening population and will be eligible for participation: 1. Male and females between the ages 14 and 58 years at the time of consent; 2. Closed physeal plates at the time of consent; 3. Intermetatarsal angle is between 10.0˚ - 22.0˚; 4. Hallux valgus angle is between 16.0˚ - 40.0˚; 5. Willing and able to adhere to early weight-bearing instructions post-operatively; 6. Capable of completing self-administered questionnaires; 7. Acceptable surgical candidate, including use of general anesthesia; 8. Female patients must be of non-child bearing potential or have a negative pregnancy test within 7 days prior to index procedure; 9. Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits; 10. Willing and able to provide written informed consent.
Exclusion criteria
Patients satisfying the following criteria will not be eligible for participation: 1. Previous surgery for hallux valgus on operative side; 2. Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe or lesser toes/digits); 3. Additional concomitant procedures outside of the 1st ray; 4. Moderate or Severe osteoarthritis of the MTP joint based on radiographic imaging (including lack of evident crista) or positive grind test; 5. Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination \<5˚and talonavicular subluxation/uncovering \>50%); 6. BMI \>40 kg/m²; 7. Current nicotine user, including current use of nicotine patch; 8. Current clinical diagnosis of diabetes with fasting plasma glucose \> 126 mg/dL and/or HbA1c ≥7.0; 9. Current clinical diagnosis of peripheral neuropathy or by assessment on 4-point monofilament test; 10. Current clinical diagnosis of fibromyalgia; 11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD); 12. Current uncontrolled hypothyroidism; 13. Previously sensitized to titanium; 14. Currently taking oral steroids or rheumatoid biologics; 15. Currently taking immunosuppressant drugs; 16. 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; 17. Active, suspected or latent infection in the affected area; 18. Use of synthetic or allogenic bone graft substitutes; 19. Current diagnosis of metatarsus adductus (defined as MAA ≥ 23˚); 20. Known keloid and hypertrophic scar forming; 21. 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; 22. Patient has previously been enrolled into this study for a contralateral procedure; 23. Scheduled for any concomitant procedure that would alter patient's ability to early weight-bear post-procedure; 24. Patient requires an incision \>4.0 cm to complete the procedure (determined pre-operatively or intra-operatively); 25. Patient is actively involved with a workman's compensation case or is currently involved in litigation; 26. 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; 27. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Recurrence | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Angular Measurements | pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure | Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure \[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure\]. |
| Number Of Patients With Radiographic Non-Union | 12 months post Lapiplasty® Procedure | 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 |
| 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 | 24 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 to Start Weight-bearing in a Boot, in Days | 0-3 weeks, post Lapiplasty® Procedure | Time to start weight-bearing in a boot, in days |
| Time to Start Weight-bearing in a Shoe | From time of procedure up to 6 weeks | Time to start weight-bearing in a shoe |
| Time to Return to Full Unrestricted Activity, in Days | From time of procedure up to 4 months | Time to return to full unrestricted activity, in days |
| Change in Pain | 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure | 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. |
| Change in Range of Motion | 12 months, 24 months post Lapiplasty® Procedure | 1st MTP dorsiflexion and plantarflexion |
| Change in PROMIS - Quality of Life Score | 6 months, 12 months, 24 months post Lapiplasty® Procedure | 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. |
| Change in Quality of Life - MOxFQ | 6 months, 12 months, 24 months post Lapiplasty® Procedure | 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). |
| Change in Radiographic Foot Length | 12 months post Lapiplasty® Procedure | Change in radiographic foot length compared to baseline visit. |
| Change in Radiographic Foot Width | 12 months post Lapiplasty® Procedure | Change in radiographic foot width (mm) compared to baseline visit |
| Change in Swelling at Foot, Ankle & Mid-Calf (Circumference) | 6 weeks and 4 months post Lapiplasty® Procedure | Change in swelling as compared to 0-14 day visit. |
| Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS) | 4 months, 6 months, and 12 months post Lapiplasty® Procedure | 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. |
| Change in Tibial Sesamoid Position (TSP) | pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure | 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. |
| Change in Osseous Foot Width (OFW) | pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure | Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure \[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure\]. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJody McAleer, DPM, FACFAS
JCMG - Podiatry
Participant flow
Recruitment details
Of 123 enrolled (signed informed consent) study subjects, 108 met inclusion and exclusion criteria and received surgical treatment. Of 108 who received surgical treatment, 3 were intraoperative screen failures and 105 continued in the study.
Pre-assignment details
There was only one treatment arm in this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 98 Participants |
| Age, Continuous | 41.0 years STANDARD_DEVIATION 12.4 |
| BMI | 25.2 kg/m^2 STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Labor Class at Baseline Heavy Work | 3 Participants |
| Labor Class at Baseline Light Work | 39 Participants |
| Labor Class at Baseline Medium Work | 28 Participants |
| Labor Class at Baseline Sedentary | 35 Participants |
| Operative Foot Left Foot | 54 Participants |
| Operative Foot Right Foot | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 80 Participants |
| Region of Enrollment United States | 105 participants |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 105 |
| other Total, other adverse events | 11 / 105 |
| serious Total, serious adverse events | 1 / 105 |
Outcome results
None listed