Trial Outcomes & Findings for Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap (NCT NCT01684839)
NCT ID: NCT01684839
Last Updated: 2024-02-15
Results Overview
The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent \<6 mm; good 6-10 mm; fair 11-15 mm; poor \>15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.
COMPLETED
NA
9 participants
20-26 months postoperatively
2024-02-15
Participant Flow
Nine patients were included in the study. These patients were treated with the pedicled nerve flap. The type of location was medical clinic.
No wash out, run-in or transition happened in the study.
Participant milestones
| Measure |
New Surgical Treatment
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
Baseline characteristics by cohort
| Measure |
New Surgical Treatment
n=9 Participants
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20-26 months postoperativelyThe Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent \<6 mm; good 6-10 mm; fair 11-15 mm; poor \>15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.
Outcome measures
| Measure |
New Surgical Treatment
n=9 Participants
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
|
|---|---|
|
Static 2-point Discrimination Test
|
7.3 mm
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 20-26 months postoperativelyThe maximum score was 100 and was grouped into 4 ranges (0-25; 26-50; 51-75; and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 20-26 months postoperativelyTinel's sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma
Outcome measures
Outcome data not reported
Adverse Events
New Surgical Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place