PainPAPDAPNCT04378062
Pain After Proximal Digital Amputation Prevention
A study testing Digital nerve procedure in people with Pain and Amputation Neuroma, run by Indiana University at 1 site in United States.
Trial summary
Finger amputations are common and may be complicated by debilitating nerve pain. This study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (TMR) or regenerative peripheral nerve interfaces… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Amputation Neuroma, Amputation
- What is being tested?
- Digital nerve procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 1 Feb 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring single finger amputations at the level of the proximal interphalangeal joint or proximal (i.e., closer to the body than this joint).
- Patients have the capacity to complete the informed consent process
Who cannot join
- Patients less than 18 years of age, prisoner, or other vulnerable population
- Patients with significant concomitant ipsilateral extremity injuries that would confound study
- Patients requiring emergent, staged (guillotine-type) amputations of any kind
Trial locations and contacts
1 site in 1 country.
About this study
Finger amputations are common and may be complicated by debilitating nerve pain. This study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (TMR) or regenerative peripheral nerve interfaces (RPNI)-compared to standard treatment by traction neurectomy (TN).
Read the detailed description
Patients who require proximal amputations will have the opportunity to enroll in the study, will be randomized intraoperatively to receiving one of the aforementioned treatments, and will be followed at 3 and 6 month for outcome measures.
- Conditions
- Pain, Amputation Neuroma, Amputation
- Being tested
- Digital nerve procedure
- Keywords
- Pain, Amputation Neuroma, Finger Amputation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital nerve procedureProcedure or surgery
The type of procedure performed on the digital nerve at the time of amputation
| Study group | Role | What they receive |
|---|---|---|
| Traction Neurectomy | Active comparator | Traction neurectomy - of digital sensory nerves at the time of amputation. Receives: Procedure: Digital nerve procedure |
| Targeted Muscle Reinnervation | Experimental | Targeted Muscle Reinnervation - of digital sensory nerves at the time of amputation Receives: Procedure: Digital nerve procedure |
| Regenerative Peripheral Nerve Interface | Experimental | Regenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation Receives: Procedure: Digital nerve procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
bMHQ
Breif Michigan Hand Questionnaire Score difference
Measured: 3 months postop minus preop; 6 months postop minus preop
Secondary outcomes (2)
NPS
Numerical Pain Score difference
Measured: 3 months postop minus preop; 6 months postop minus preop
Grip strength
Grip strength score difference
Measured: 3 months postop minus preop; 6 months postop minus preop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Mar 2020
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Surgery of the Hand
- Responsible party
- Principal investigator, Joshua Adkinson, Indiana University
- Investigators
- Joshua Adkinson, MD, Principal investigator, Indiana UniversityScott N Loewenstein, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378062
- Sponsor's protocol ID
- 1907889836
- Acronym
- PAPDAP
- Status last verified
- Aug 2023
- First submitted
- 4 May 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Proximal Digital Amputation Prevention
- ClinicalTrials.gov ID
- NCT04378062
- Acronym / sponsor ID
- PAPDAP / 1907889836
- Conditions
- Pain, Amputation Neuroma, Amputation
- Keywords
- Pain, Amputation Neuroma, Finger Amputation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate enrollment
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American Society for Surgery of the Hand
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 7 May 2020 (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.
Finger amputations are common and may be complicated by debilitating nerve pain. This study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (TMR) or regenerative peripheral nerve interfaces (RPNI)-compared to standard treatment by traction neurectomy (TN).
Detailed description
Patients who require proximal amputations will have the opportunity to enroll in the study, will be randomized intraoperatively to receiving one of the aforementioned treatments, and will be followed at 3 and 6 month for outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traction Neurectomy | Active comparator | Procedure: Digital nerve procedureTraction neurectomy - of digital sensory nerves at the time of amputation. |
| Targeted Muscle Reinnervation | Experimental | Procedure: Digital nerve procedureTargeted Muscle Reinnervation - of digital sensory nerves at the time of amputation |
| Regenerative Peripheral Nerve Interface | Experimental | Procedure: Digital nerve procedureRegenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients requiring single finger amputations at the level of the proximal interphalangeal joint or proximal (i.e., closer to the body than this joint).
- Patients have the capacity to complete the informed consent process
Key exclusion criteria (3 listed)
- Patients less than 18 years of age, prisoner, or other vulnerable population
- Patients with significant concomitant ipsilateral extremity injuries that would confound study
- Patients requiring emergent, staged (guillotine-type) amputations of any kind
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 |
|---|---|---|
| Digital nerve procedureThe type of procedure performed on the digital nerve at the time of amputation | Procedure or surgery | Regenerative Peripheral Nerve Interface, Targeted Muscle Reinnervation, Traction Neurectomy |
Primary outcome
bMHQ
Time frame: 3 months postop minus preop; 6 months postop minus preop
Breif Michigan Hand Questionnaire Score difference
2 secondary outcomes
NPS
Time frame: 3 months postop minus preop; 6 months postop minus preop
Grip strength
Time frame: 3 months postop minus preop; 6 months postop minus preop
Results and safety
The study was stopped early (reason given: inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- 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.
Joshua Adkinson, MD principal investigator
Indiana University
Scott N Loewenstein, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital nerve procedure in people with Pain and Amputation Neuroma, run by Indiana University at 1 site 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 2 inclusion and 3 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: inadequate enrollment). Results are not available in the source record.
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?
bMHQ (time frame: 3 months postop minus preop; 6 months postop minus preop). 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 30 Aug 2023.