Trial Outcomes & Findings for Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D) (NCT NCT05082012)
NCT ID: NCT05082012
Last Updated: 2026-04-20
Results Overview
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
TERMINATED
NA
123 participants
24 months
2026-04-20
Participant Flow
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.
There was only one treatment arm in this study.
Participant milestones
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
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Overall Study
STARTED
|
123
|
|
Overall Study
Number of Patients Who Received Study Treatment
|
105
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
112
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
Baseline characteristics by cohort
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=129 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
98 Participants
n=129 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=129 Participants
|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 12.4 • n=129 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=129 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=129 Participants
|
|
BMI
|
25.2 kg/m^2
STANDARD_DEVIATION 4.9 • n=129 Participants
|
|
Operative Foot
Left Foot
|
54 Participants
n=129 Participants
|
|
Operative Foot
Right Foot
|
51 Participants
n=129 Participants
|
|
Labor Class at Baseline
Sedentary
|
35 Participants
n=129 Participants
|
|
Labor Class at Baseline
Light Work
|
39 Participants
n=129 Participants
|
|
Labor Class at Baseline
Medium Work
|
28 Participants
n=129 Participants
|
|
Labor Class at Baseline
Heavy Work
|
3 Participants
n=129 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Company decision to close study early due to change in commercialization strategy.
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
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=11 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
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|---|---|
|
Radiographic Recurrence
|
0 Participants
|
SECONDARY outcome
Timeframe: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® ProcedurePopulation: Company decision to close study early due to change in commercialization strategy. The number of subjects analyzed at each study time point is based on assessments collected and number of subjects who returned for follow up visits. Not all study subjects returned for all study timepoint follow up visits nor could all study subjects complete the study due to early termination of the study due to sponsor commercialization strategy.
Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure \[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure\].
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
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|---|---|
|
Radiographic Angular Measurements
Sagittal Plane Change from Baseline at Month 6
|
1.0 Degree
Interval 0.4 to 1.5
|
|
Radiographic Angular Measurements
HVA Change from Baseline at Month 12
|
-19.3 Degree
Interval -20.9 to -17.6
|
|
Radiographic Angular Measurements
IMA Change from Baseline at Month 12
|
-9.4 Degree
Interval -10.1 to -8.8
|
|
Radiographic Angular Measurements
Sagittal Plane Change from Baseline at Month 12
|
0.9 Degree
Interval 0.3 to 1.6
|
|
Radiographic Angular Measurements
HVA Change from Baseline at Month 24
|
-18.6 Degree
Interval -23.0 to -14.3
|
|
Radiographic Angular Measurements
IMA Change from Baseline at Month 24
|
-10.0 Degree
Interval -11.4 to -8.5
|
|
Radiographic Angular Measurements
Sagittal Plane Change from Baseline at Month 24
|
1.4 Degree
Interval -0.9 to 3.7
|
|
Radiographic Angular Measurements
IMA Change from Baseline at Month 6
|
-9.5 Degree
Interval -10.1 to -8.8
|
|
Radiographic Angular Measurements
Baseline HVA
|
26.6 Degree
Interval 25.3 to 27.8
|
|
Radiographic Angular Measurements
Baseline IMA
|
14.1 Degree
Interval 13.5 to 14.6
|
|
Radiographic Angular Measurements
Baseline Sagittal Plane
|
0.3 Degree
Interval -0.1 to 0.8
|
|
Radiographic Angular Measurements
HVA Change from Baseline at Week 6
|
-20.3 Degree
Interval -21.7 to -18.8
|
|
Radiographic Angular Measurements
IMA Change from Baseline at Week 6
|
-10.4 Degree
Interval -11.0 to -9.8
|
|
Radiographic Angular Measurements
Sagittal Plane change from Baseline at Week 6
|
1.4 Degree
Interval 0.8 to 2.0
|
|
Radiographic Angular Measurements
HVA Change from Baseline at Month 4
|
-20.1 Degree
Interval -21.4 to -18.7
|
|
Radiographic Angular Measurements
IMA Change from Baseline at Month 4
|
-9.9 Degree
Interval -10.5 to -9.3
|
|
Radiographic Angular Measurements
Sagittal Plane Change from Baseline at Month 4
|
1.0 Degree
Interval 0.4 to 1.6
|
|
Radiographic Angular Measurements
HVA Change from Baseline at Month 6
|
-20.2 Degree
Interval -21.7 to -18.8
|
SECONDARY outcome
Timeframe: 12 months post Lapiplasty® ProcedurePopulation: Company decision to close study early due to change in commercialization strategy. Due to early termination and study subjects who may not have returned for follow up visits only the number of study subjects with 12-month data at the time of study termination was analyzed.
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
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=75 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Number Of Patients With Radiographic Non-Union
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 months post Lapiplasty® ProcedurePopulation: Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105. There were 11 study subjects who had a total of 12 adverse events with one being a serious adverse event.
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
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
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
Hardware removal due to pain
|
1 Participants
|
|
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
Hardware failure (hardware not removed)
|
1 Participants
|
|
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
Pain
|
5 Participants
|
|
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
Infection
|
2 Participants
|
|
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
Allergic reaction to surgical glue
|
1 Participants
|
|
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
Malunion
|
1 Participants
|
|
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
Skin abrasion
|
1 Participants
|
|
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
Cuneiform fracture
|
1 Participants
|
|
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
Stiffness
|
1 Participants
|
SECONDARY outcome
Timeframe: 0-3 weeks, post Lapiplasty® ProcedurePopulation: Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
Time to start weight-bearing in a boot, in days
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
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|---|---|
|
Time to Start Weight-bearing in a Boot, in Days
|
7.9 Days
Interval 6.7 to 9.1
|
SECONDARY outcome
Timeframe: From time of procedure up to 6 weeksPopulation: Company decision to close study early due to change in commercialization strategy. The number of subjects analyzed at each study time point is based on assessments collected and number of subjects who returned for follow up visits. Not all study subjects returned for all study timepoint follow up visits nor could all study subjects complete the study due to early termination of the study due to sponsor commercialization strategy.
Time to start weight-bearing in a shoe
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=104 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Time to Start Weight-bearing in a Shoe
|
43.0 Days
Interval 41.2 to 44.8
|
SECONDARY outcome
Timeframe: From time of procedure up to 4 monthsPopulation: Company decision to close study early due to change in commercialization strategy. The number of subjects analyzed at each study time point is based on assessments collected and number of subjects who returned for follow up visits. Not all study subjects returned for all study timepoint follow up visits nor could all study subjects complete the study due to early termination of the study due to sponsor commercialization strategy.
Time to return to full unrestricted activity, in days
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=100 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Time to Return to Full Unrestricted Activity, in Days
|
115.0 Days
Interval 104.5 to 125.5
|
SECONDARY outcome
Timeframe: 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® ProcedurePopulation: Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
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.
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Change in Pain
Baseline
|
3.5 score on a scale
Interval 3.1 to 3.9
|
|
Change in Pain
Change from Baseline at 6 Weeks
|
-1.8 score on a scale
Interval -2.3 to -1.4
|
|
Change in Pain
Change from Baseline at 4 Months
|
-2.1 score on a scale
Interval -2.5 to -1.6
|
|
Change in Pain
Change from Baseline at 6 Months
|
-2.3 score on a scale
Interval -2.7 to -1.8
|
|
Change in Pain
Change from Baseline at 12 Months
|
-2.6 score on a scale
Interval -3.2 to -2.1
|
|
Change in Pain
Change from Baseline at 24 Months
|
-1.9 score on a scale
Interval -3.2 to -0.6
|
SECONDARY outcome
Timeframe: 12 months, 24 months post Lapiplasty® ProcedurePopulation: Only 75 study subjects analyzed at 12 months and 11 study subjects at 24 months due to sponsor termination of study.
1st MTP dorsiflexion and plantarflexion
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Change in Range of Motion
Baseline - Range of Motion -Dorsiflexion
|
61.8 degrees
Interval 59.2 to 64.4
|
|
Change in Range of Motion
Change from Baseline - Range of Motion 12 mo Dorsiflexion
|
-4.5 degrees
Interval -8.0 to -1.1
|
|
Change in Range of Motion
Change from Baseline - Range of Motion 24 mo Dorsiflexion
|
0.3 degrees
Interval -15.5 to 16.1
|
|
Change in Range of Motion
Baseline - Range of Motion - Plantarflexion
|
26.4 degrees
Interval 23.8 to 29.1
|
|
Change in Range of Motion
Change from Baseline - Range of Motion 12 mo Plantarflexion
|
0.2 degrees
Interval -3.2 to 3.6
|
|
Change in Range of Motion
Change from Baseline - Range of Motion 24 mo Plantarflexion
|
-7.0 degrees
Interval -15.8 to 1.8
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 24 months post Lapiplasty® ProcedurePopulation: Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105. Of the 105-analysis population there were 6 pediatric subjects and 99 adult subjects. Only 1 pediatric study subject reached the 24 month follow up visit and therefore the change from baseline values are not estimable.
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.
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-25 -Pediatric - Anxiety
|
55.8 score on a scale
Interval 42.8 to 68.8
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-25 -Pediatric - Pain Intensity
|
2.3 score on a scale
Interval 1.2 to 3.4
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-25 Pediatric - Physical Function
|
46.3 score on a scale
Interval 38.6 to 53.9
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-25 -Pediatric - Anxiety
|
-11.9 score on a scale
Interval -25.9 to 2.1
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Months PROMIS-25 - Pediatric - Anxiety
|
-15.7 score on a scale
Interval -36.2 to 4.9
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-25 -Pediatric - Depression
|
49.6 score on a scale
Interval 40.0 to 59.1
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-25 -Pediatric - Depression
|
-7.2 score on a scale
Interval -10.9 to -3.4
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Months PROMIS-25 - Pediatric - Depression
|
-1.7 score on a scale
Interval -10.2 to 6.9
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-25 -Pediatric - Fatigue
|
49.7 score on a scale
Interval 37.0 to 62.4
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-25 -Pediatric - Fatigue
|
-11.9 score on a scale
Interval -23.9 to 0.1
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Months PROMIS-25 - Pediatric - Fatigue
|
-10.9 score on a scale
Interval -25.9 to 4.1
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-25 -Pediatric - Pain Intensity
|
-0.5 score on a scale
Interval -3.7 to 2.7
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-25 -Pediatric - Pain Intensity
|
-1.0 score on a scale
Interval -3.5 to 1.5
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-25 -Pediatric - Pain Interference
|
52.6 score on a scale
Interval 45.8 to 59.4
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-25 -Pediatric - Pain Interference
|
-7.1 score on a scale
Interval -21.6 to 7.5
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-25 -Pediatric - Pain Inteference
|
-9.9 score on a scale
Interval -20.6 to 0.7
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-25 -Pediatric - Peer Relationships
|
53.3 score on a scale
Interval 46.0 to 60.6
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-25 -Pediatric - Peer Relationships
|
3.0 score on a scale
Interval -2.5 to 8.5
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-25 -Pediatric - Peer Relationships
|
2.4 score on a scale
Interval -6.0 to 10.9
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-25 -Pediatric - Physical Function
|
5.2 score on a scale
Interval -5.1 to 15.4
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-25 -Pediatric - Physical Function
|
7.5 score on a scale
Interval -3.6 to 18.7
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-29- Ability to Participate in Social Roles/Activities
|
54.1 score on a scale
Interval 52.3 to 56.0
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month - PROMIS-29-Adult - Ability to Participate in Social Roles/Activities
|
4.7 score on a scale
Interval 3.0 to 6.4
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month - PROMIS-29-Adult - Ability to Participate in Social Roles/Activities
|
7.2 score on a scale
Interval 5.0 to 9.3
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 24 Month - PROMIS-29-Adult - Ability to Participate in Social Roles/Activities
|
7.1 score on a scale
Interval 2.8 to 11.3
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-29- Adult - Anxiety
|
48.3 score on a scale
Interval 46.3 to 50.2
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-29- Adult - Anxiety
|
-3.4 score on a scale
Interval -5.2 to -1.6
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-29- Adult - Anxiety
|
-4.7 score on a scale
Interval -6.7 to -2.6
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 24 Month PROMIS-29- Adult - Anxiety
|
-7.8 score on a scale
Interval -15.6 to -0.1
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-29- Adult - Depression
|
44.9 score on a scale
Interval 43.3 to 46.4
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-29- Adult - Depression
|
-1.3 score on a scale
Interval -2.5 to -0.1
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-29- Adult - Depression
|
-1.5 score on a scale
Interval -2.9 to -0.2
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 24 Month PROMIS-29- Adult - Depression
|
-4.8 score on a scale
Interval -11.8 to 2.2
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-29- Adult - Fatigue
|
45.8 score on a scale
Interval 43.7 to 47.8
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-29- Adult - Fatigue
|
-3.5 score on a scale
Interval -5.4 to -1.6
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-29- Adult - Fatigue
|
-4.6 score on a scale
Interval -6.7 to -2.5
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 24 Month PROMIS-29- Adult - Fatigue
|
-5.8 score on a scale
Interval -13.0 to 1.4
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-29- Adult - Pain Intensity
|
3.9 score on a scale
Interval 3.5 to 4.3
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-29- Adult - Pain Intensity
|
-2.5 score on a scale
Interval -3.0 to -2.0
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-29- Adult - Pain Intensity
|
-3.1 score on a scale
Interval -3.7 to -2.5
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 24 Month PROMIS-29- Adult - Pain Intensity
|
-2.9 score on a scale
Interval -4.3 to -1.5
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-29- Adult - Pain Interference
|
54.1 score on a scale
Interval 52.4 to 55.8
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-29- Adult - Pain Interference
|
-8.2 score on a scale
Interval -10.0 to -6.4
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-29- Adult - Pain Interference
|
-10.4 score on a scale
Interval -12.4 to -8.3
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 24 Month PROMIS-29- Adult - Pain Interference
|
-9.3 score on a scale
Interval -13.1 to -5.5
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-29- Adult - Physical Function
|
45.9 score on a scale
Interval 44.2 to 47.5
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-29- Adult - Physical Function
|
6.8 score on a scale
Interval 4.9 to 8.7
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-29- Adult - Physical Function
|
9.5 score on a scale
Interval 7.5 to 11.4
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 24 Month PROMIS-29- Adult - Physical Function
|
8.5 score on a scale
Interval 3.4 to 13.6
|
|
Change in PROMIS - Quality of Life Score
Baseline PROMIS-29- Adult - - Sleep Disturbance
|
49.1 score on a scale
Interval 47.6 to 50.6
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 6 Month PROMIS-29- Adult - Sleep Disturbance
|
-4.0 score on a scale
Interval -5.6 to -2.3
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 12 Month PROMIS-29- Adult - Sleep Disturbance
|
-4.8 score on a scale
Interval -6.5 to -3.1
|
|
Change in PROMIS - Quality of Life Score
Change from Baseline 24 Month PROMIS-29- Adult - Sleep Disturbance
|
-4.2 score on a scale
Interval -12.4 to 4.1
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 24 months post Lapiplasty® ProcedurePopulation: Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105. Of the 105-analysis population there were 6 pediatric subjects and 99 adult subjects. Only 1 pediatric study subject reached the 24 month follow up visit and therefore the change from baseline values are not estimable.
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).
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Change in Quality of Life - MOxFQ
Baseline - MOxFQ- Social Interaction
|
42.7 score on a scale
Interval 38.7 to 46.8
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 6 mo - MOxFQ - Social Interaction
|
-27.4 score on a scale
Interval -32.0 to -22.8
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 12 mo - MOxFQ - Social Interaction
|
-33.8 score on a scale
Interval -38.6 to -28.9
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 24 mo - MOxFQ - Social Interaction
|
-28.4 score on a scale
Interval -42.9 to -13.9
|
|
Change in Quality of Life - MOxFQ
Baseline - MOxFQ- Walking/Standing
|
41.2 score on a scale
Interval 36.7 to 45.8
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 6 mo - MOxFQ - Walking/Standing
|
-22.3 score on a scale
Interval -27.7 to -16.9
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 12 mo - MOxFQ - Walking/Standing
|
-32.0 score on a scale
Interval -37.9 to -26.0
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 24 mo - MOxFQ - Walking/Standing
|
-26.6 score on a scale
Interval -39.7 to -13.5
|
|
Change in Quality of Life - MOxFQ
Baseline - MOxFQ - Pain
|
50.2 score on a scale
Interval 46.6 to 53.9
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 6 mo - MOxFQ - Pain
|
-26.8 score on a scale
Interval -31.9 to -21.7
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 12 mo - MOxFQ - Pain
|
-36.7 score on a scale
Interval -42.4 to -31.1
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 24 mo - MOxFQ - Pain
|
-38.2 score on a scale
Interval -51.4 to -25.0
|
|
Change in Quality of Life - MOxFQ
Baseline - MOxFQ - Index Score
|
44.4 score on a scale
Interval 40.8 to 48.1
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 6 mo - MOxFQ - Index Score
|
-25.0 score on a scale
Interval -29.5 to -20.4
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 24 mo - MOxFQ - Index Score
|
-30.7 score on a scale
Interval -41.6 to -19.7
|
|
Change in Quality of Life - MOxFQ
Change from Baseline - 12 mo - MOxFQ - Index Score
|
-33.9 score on a scale
Interval -38.8 to -29.0
|
SECONDARY outcome
Timeframe: 12 months post Lapiplasty® ProcedurePopulation: Measured in 75 study subjects at 12 mo due to early study termination by the sponsor.
Change in radiographic foot length compared to baseline visit.
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Change in Radiographic Foot Length
Change from Baseline - Sagittal Length - 12 mo
|
-1.8 mm
Interval -2.5 to -1.2
|
|
Change in Radiographic Foot Length
Baseline Sagittal Length
|
84.7 mm
Interval 83.0 to 86.4
|
SECONDARY outcome
Timeframe: 12 months post Lapiplasty® ProcedurePopulation: Measured in 75 study subjects at 12 mo due to the early termination by the sponsor.
Change in radiographic foot width (mm) compared to baseline visit
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Change in Radiographic Foot Width
Baseline Osseous Foot Width
|
91.0 mm
Interval 89.1 to 93.0
|
|
Change in Radiographic Foot Width
Change from Baseline - Osseous Foot Width - 12 mo
|
-7.0 mm
Interval -7.8 to -6.2
|
SECONDARY outcome
Timeframe: 6 weeks and 4 months post Lapiplasty® ProcedurePopulation: Due to missed visits or missed assessments the number of study subjects analyzed is different than the overall number analyzed.
Change in swelling as compared to 0-14 day visit.
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Baseline Mid-Foot Circumference
|
20.2 cm
Interval 19.6 to 20.8
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Change from Baseline - 6 week Mid-Foot Circumference
|
0.7 cm
Interval 0.4 to 1.0
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Change from Baseline - 4 mo - Mid-Foot Circumference
|
0.3 cm
Interval 0.0 to 0.6
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Baseline Fore-Foot Circumference
|
20.7 cm
Interval 20.1 to 21.3
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Change from Baseline - 6 week Fore-Foot Circumference
|
0.1 cm
Interval -0.1 to 0.4
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Change from Baseline - 4 mo Fore-Foot Circumference
|
-0.5 cm
Interval -0.7 to -0.2
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Baseline Ankle Circumference
|
20.7 cm
Interval 19.9 to 21.5
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Change from Baseline - 6 week Ankle Circumference
|
0.2 cm
Interval -0.2 to 0.5
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Change from Baseline - 4 mo Ankle Circumference
|
0.1 cm
Interval -0.3 to 0.5
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Baseline Calf Circumference
|
33.4 cm
Interval 32.5 to 34.3
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Change from Baseline - 6 week Calf Circumference
|
-1.9 cm
Interval -2.5 to -1.3
|
|
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Change from Baseline - 4 mo Calf Circumference
|
-1.0 cm
Interval -1.6 to -0.5
|
SECONDARY outcome
Timeframe: 4 months, 6 months, and 12 months post Lapiplasty® ProcedurePopulation: 98 of the 105 overall study subjects analyzed is due to missed visits and/or missed assessments.
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.
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=98 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)
POSAS Observer - 6 mo
|
12.1 score on a scale
Interval 11.2 to 13.1
|
|
Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)
POSAS Observer - 12 mo
|
10.8 score on a scale
Interval 9.8 to 11.8
|
|
Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)
POSAS Patient - 4 mo
|
22.7 score on a scale
Interval 20.4 to 24.9
|
|
Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)
POSAS Patient - 6 mo
|
18.2 score on a scale
Interval 16.0 to 20.4
|
|
Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)
POSAS Observer - 4 mo
|
14.6 score on a scale
Interval 13.4 to 15.9
|
|
Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)
POSAS Patient - 12 mo
|
13.4 score on a scale
Interval 11.6 to 15.2
|
SECONDARY outcome
Timeframe: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® ProcedurePopulation: Company decision to close study early due to change in commercialization strategy. The number of subjects analyzed at each study time point is based on assessments collected and number of subjects who returned for follow up visits. Not all study subjects returned for all study timepoint follow up visits nor could all study subjects complete the study due to early termination of the study due to sponsor commercialization strategy.
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.
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Change in Tibial Sesamoid Position (TSP)
Baseline TSP
|
5.0 score on a scale
Interval 4.8 to 5.3
|
|
Change in Tibial Sesamoid Position (TSP)
TSP Change from Baseline at Week 6
|
1.7 score on a scale
Interval 1.5 to 1.9
|
|
Change in Tibial Sesamoid Position (TSP)
TSP Change from Baseline at Month 4
|
2.1 score on a scale
Interval 1.9 to 2.4
|
|
Change in Tibial Sesamoid Position (TSP)
TSP Change from Baseline at Month 6
|
2.3 score on a scale
Interval 2.1 to 2.6
|
|
Change in Tibial Sesamoid Position (TSP)
TSP Change from Baseline at Month 12
|
2.7 score on a scale
Interval 2.4 to 3.0
|
|
Change in Tibial Sesamoid Position (TSP)
TSP Change from Baseline at Month 24
|
1.9 score on a scale
Interval 1.4 to 2.5
|
SECONDARY outcome
Timeframe: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® ProcedurePopulation: Company decision to close study early due to change in commercialization strategy. The number of subjects analyzed at each study time point is based on assessments collected and number of subjects who returned for follow up visits. Not all study subjects returned for all study timepoint follow up visits nor could all study subjects complete the study due to early termination of the study due to sponsor commercialization strategy.
Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure \[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure\].
Outcome measures
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 Participants
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Change in Osseous Foot Width (OFW)
Baseline Osseous Foot Width
|
91.0 mm
Interval 89.1 to 93.0
|
|
Change in Osseous Foot Width (OFW)
Baseline Sagittal 1st Ray Length
|
84.7 mm
Interval 83.0 to 86.4
|
|
Change in Osseous Foot Width (OFW)
Baseline 1-2 Metatarsal Length
|
-3.0 mm
Interval -3.5 to -2.4
|
|
Change in Osseous Foot Width (OFW)
Osseous Foot Width Change from Baseline at Month 6
|
-7.4 mm
Interval -8.0 to -6.8
|
|
Change in Osseous Foot Width (OFW)
Sagittal 1st Ray Length Change from Baseline at Month 6
|
-2.0 mm
Interval -2.5 to -1.5
|
|
Change in Osseous Foot Width (OFW)
1-2 Metatarsal Length Change from Baseline at Month 6
|
-2.6 mm
Interval -3.0 to -2.2
|
|
Change in Osseous Foot Width (OFW)
Osseous Foot Width Change from Baseline at Month 12
|
-7.0 mm
Interval -7.8 to -6.2
|
|
Change in Osseous Foot Width (OFW)
Sagittal 1st Ray Length Change from Baseline at Month 12
|
-1.8 mm
Interval -2.5 to -1.2
|
|
Change in Osseous Foot Width (OFW)
1-2 Metatarsal Length Change from Baseline at Month 12
|
-2.4 mm
Interval -2.8 to -2.1
|
|
Change in Osseous Foot Width (OFW)
Osseous Foot Width Change from Baseline at Month 24
|
-8.6 mm
Interval -12.4 to -4.7
|
|
Change in Osseous Foot Width (OFW)
Sagittal 1st Ray Length Change from Baseline at Month 24
|
-3.9 mm
Interval -6.5 to -1.3
|
|
Change in Osseous Foot Width (OFW)
1-2 Metatarsal Length Change from Baseline at Month 24
|
-2.6 mm
Interval -3.7 to -1.5
|
Adverse Events
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Serious adverse events
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 participants at risk
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.95%
1/105 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
n=105 participants at risk
Of the 123 study subjects enrolled, 108 patients met inclusion/exclusion criteria, and the index procedure was performed. Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
4.8%
5/105 • Number of events 5 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Infection
|
1.9%
2/105 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Allergic reaction to surgical glue
|
0.95%
1/105 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Malunion
|
0.95%
1/105 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Skin abrasion, superficial abscess due to activity along distal incision
|
0.95%
1/105 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
0.95%
1/105 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Cuneiform fracture
|
0.95%
1/105 • Number of events 1 • 24 months
|
Additional Information
Director, Clinical Affairs
Treace Medical Concepts, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60