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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05009394
Registration number
NCT05009394
Ethics application status
Date submitted
12/07/2021
Date registered
17/08/2021
Date last updated
29/09/2023
Titles & IDs
Public title
Surgical Treatments for Postamputation Pain
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Scientific title
Surgical Treatments for Postamputation Pain
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Secondary ID [1]
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2021-02346
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Residual Limb Pain
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Amputation Neuroma
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Phantom Limb Pain
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Pain, Neuropathic
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Pain, Nerve
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Targeted Muscle Reinnervation (TMR)
Treatment: Surgery - Regenerative Peripheral Nerve Interface (RPNI)
Treatment: Surgery - Standard neuroma treatment, neuroma excision, and muscle burying
Active Comparator: Targeted Muscle Reinnervation (TMR) - The surgical procedure comprises three steps: preparation of the donor nerve, identification of a motor branch to the targeted muscle, and nerve coaptation. To prepare the donor nerve, the surgeon will identify the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Next, the surgeon will identify a motor branch to a nearby target muscle and will confirm muscle contraction using a hand-held nerve stimulator. The motor branch to the target muscle will be transected as close as possible to its entry point without tension. In the final step, the previous nerve stump from which the neuroma was resected will be transferred and coapted to the newly severed motor branch that innervates the target muscle and secured by 2-3 non-resorbable monofilament sutures. The surgery time is approximately 2-3 hours and it takes place in the hospital.
Active Comparator: Regenerative Peripheral Nerve Interface (RPNI) - The RPNI procedure involves construction of a residual peripheral nerve split into several nerve fascicles and implanted into free skeletal muscle grafts. First, the surgeon identifies the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Then, a longitudinal intraneural dissection will be performed exposing its fascicles. Next, autologous muscle grafts will be harvested from a healthy donor site, and the dissected nerve stumps will be placed parallel to the muscle fibers. The nerve stump will be secured to the muscle graft, thereafter the graft will be wrapped around the nerve stump and anchored in the folded graft, thus creating an RPNI. This will be repeated for each fascicle obtained from splitting the transected nerve. Lastly, the RPNIs will be placed in a protected area. The surgery time is approximately 2-3 hours and it takes place in the hospital.
Active Comparator: Standard neuroma treatment, neuroma excision, and muscle burying - The standard neuroma treatment, also called neuroma transposition, includes excision of the terminal neuroma and burying the nerve into an adjacent deep muscle.The standard neuroma treatment entails the excision of the terminal neuroma and then implanting the nerve into an adjacent muscle. Firstly, the surgeon will identify the nerve with a painful neuroma and thereafter resect the neuroma up to healthy fascicles. Next, the surgeon will identify a nearby muscle which is not involved in joint motion and has limited output opportunities for the nerve. The nerve will then be channeled at least 1 cm inside the muscle without applying any tension to it and secured by 1-2 non-resorbable monofilament sutures. The identified nerve with the painful neuroma will not be treated with any additional therapy than the resection (e.g., diathermy, pharmacotherapy, crushing, etc.). The surgery time is approximately 1-2 hours and it takes place in the hospital.
Treatment: Surgery: Targeted Muscle Reinnervation (TMR)
Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.
Treatment: Surgery: Regenerative Peripheral Nerve Interface (RPNI)
Surgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.
Treatment: Surgery: Standard neuroma treatment, neuroma excision, and muscle burying
Surgical procedure where the neuroma is excised and the nerve stump is buried in an adjacent deep muscle.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Residual limb pain intensity
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Assessment method [1]
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Difference in residual limb pain intensity will be measured by numerical rating scale (NRS, 0-10), where 0 - no pain and 10 - worst imaginable pain, between baseline period and at the 12-month follow-up visit.
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Timepoint [1]
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Baseline to 12-month post-surgery
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Secondary outcome [1]
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Neuroma pain intensity
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Assessment method [1]
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Difference in neuroma pain intensity will be measured by numerical rating scale (NRS, 0-10), where 0 - no pain and 10 - worst imaginable pain, between baseline period and at the 12-month follow-up visit.
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Timepoint [1]
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Baseline to 12-month post-surgery
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Secondary outcome [2]
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Phantom limb pain intensity
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Assessment method [2]
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Difference in phantom limb pain intensity will be measured by numerical rating scale (NRS, 0-10), where 0 - no pain and 10 - worst imaginable pain, between baseline period and at the 12-months follow-up visit.
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Timepoint [2]
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Baseline to12-month post-surgery
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Eligibility
Key inclusion criteria
- The participant must have a major limb amputation.
- The participant is = 18 years old at the time of consent.
- The participant must be in generally good health to undergo a surgical intervention,
as per the clinical investigator's opinion.
- Time since the last amputation must be over a year at the time of consent.
- The participant must have an average residual limb pain score equal or greater than 4
on the Numerical Rating Scale (NRS, 0-10) after the baseline period.
- If the participant has been prescribed pharmacological treatments for pain, there must
be no variations in dosage (steady consumption) for at least 1 month before the
screening visit.
- If the participant has been prescribed non-pharmacological treatments for pain, such
as spinal cord stimulation, transcutaneous electrical nerve stimulation, and mirror
therapy, the treatment must have ended at least 1 month before the screening visit.
- The participant must have a stable prosthetic fitting for at least a month before the
screening visit.
- The participant has a sufficient understanding of the language in which the
assessments will be conducted, as per the clinical investigator's opinion.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Neurological or other conditions that affect nerve regeneration for the nerve to be
treated.
- Active infection in the residual limb.
- Prior RPNI or TMR surgery of the nerve to be treated (with painful neuroma) to address
postamputation pain.
- Mental disorders (e.g., schizophrenia, paranoia, psychosis, etc.), reluctance, or
language difficulties that result in difficulty understanding the meaning of study
participation.
- Ongoing participation in a clinical study that the clinical investigator deems
detrimental to participation in this study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2028
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Actual
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Sample size
Target
110
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Dandenong Hospital, Monash Health - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
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United States of America
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Illinois
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United States of America
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Massachusetts
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United States of America
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Michigan
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Canada
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Alberta
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Chile
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Santiago
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Italy
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Emilia-Romagna
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Sweden
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Västra Götaland
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United Kingdom
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Edinburgh
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Funding & Sponsors
Primary sponsor type
Other
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Name
Center for Bionics and Pain Research
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Vastra Gotaland Region
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Other collaborator category [2]
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Other
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Göteborg University
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Other collaborator category [3]
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Other
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Chalmers University of Technology
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Other
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Istituto Ortopedico Rizzoli
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Other
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Hospital del Trabajador de Santiago
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Other
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NHS Lothian
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Other
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NHS Greater Clyde and Glasgow
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Other
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NHS Grampian
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Other
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Northwestern Memorial Hospital
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University of Michigan
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Other
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Massachusetts General Hospital
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Other
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Dandenong Hospital
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Other collaborator category [13]
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Other
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The Bionics Institute of Australia
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Other
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University of Alberta
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a double-blind randomised controlled trial (RCT) which compares the effectiveness of
three surgical techniques for alleviating residual limb pain (RLP), neuroma pain and phantom
limb pain (PLP). The three surgical treatments are Targeted Muscles Reinnervation (TMR),
Regenerative Peripheral Nerve Interface (RPNI), and an active control (neuroma excision and
muscle burying). Patients will be follow-up for 4 years.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05009394
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Trial related presentations / publications
Dumanian GA, Potter BK, Mioton LM, Ko JH, Cheesborough JE, Souza JM, Ertl WJ, Tintle SM, Nanos GP, Valerio IL, Kuiken TA, Apkarian AV, Porter K, Jordan SW. Targeted Muscle Reinnervation Treats Neuroma and Phantom Pain in Major Limb Amputees: A Randomized Clinical Trial. Ann Surg. 2019 Aug;270(2):238-246. doi: 10.1097/SLA.0000000000003088.
Souza JM, Cheesborough JE, Ko JH, Cho MS, Kuiken TA, Dumanian GA. Targeted muscle reinnervation: a novel approach to postamputation neuroma pain. Clin Orthop Relat Res. 2014 Oct;472(10):2984-90. doi: 10.1007/s11999-014-3528-7.
Woo SL, Kung TA, Brown DL, Leonard JA, Kelly BM, Cederna PS. Regenerative Peripheral Nerve Interfaces for the Treatment of Postamputation Neuroma Pain: A Pilot Study. Plast Reconstr Surg Glob Open. 2016 Dec 27;4(12):e1038. doi: 10.1097/GOX.0000000000001038. eCollection 2016 Dec.
Pettersen E, Sassu P, Reinholdt C, Dahm P, Rolfson O, Bjorkman A, Innocenti M, Pedrini FA, Breyer JM, Roche A, Hart A, Harrington L, Ladak A, Power H, Hebert J, Ortiz-Catalan M. Surgical treatments for postamputation pain: study protocol for an international, double-blind, randomised controlled trial. Trials. 2023 May 2;24(1):304. doi: 10.1186/s13063-023-07286-0. Erratum In: Trials. 2023 Oct 9;24(1):654.
Chang BL, Mondshine J, Attinger CE, Kleiber GM. Targeted Muscle Reinnervation Improves Pain and Ambulation Outcomes in Highly Comorbid Amputees. Plast Reconstr Surg. 2021 Aug 1;148(2):376-386. doi: 10.1097/PRS.0000000000008153.
Bjorklund KA, Alexander J, Tulchin-Francis K, Yanes NS, Singh S, Valerio I, Klingele K, Scharschmidt T. Targeted Muscle Reinnervation for Limb Amputation to Avoid Neuroma and Phantom Limb Pain in Patients Treated at a Pediatric Hospital. Plast Reconstr Surg Glob Open. 2023 Apr 13;11(4):e4944. doi: 10.1097/GOX.0000000000004944. eCollection 2023 Apr.
Kubiak CA, Kemp SWP, Cederna PS, Kung TA. Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain. Plast Reconstr Surg. 2019 Sep;144(3):421e-430e. doi: 10.1097/PRS.0000000000005922.
Valerio IL, Dumanian GA, Jordan SW, Mioton LM, Bowen JB, West JM, Porter K, Ko JH, Souza JM, Potter BK. Preemptive Treatment of Phantom and Residual Limb Pain with Targeted Muscle Reinnervation at the Time of Major Limb Amputation. J Am Coll Surg. 2019 Mar;228(3):217-226. doi: 10.1016/j.jamcollsurg.2018.12.015. Epub 2019 Jan 8.
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Public notes
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Contacts
Principal investigator
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Max Ortiz Catalan, PhD
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Address
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Center for Bionics and Pain Research
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Email
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Contact person for public queries
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Emily Pettersen, MSc
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Phone
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+46764026503
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05009394
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