ABSTRACT Introduction Regenerative Peripheral Nerve Interface (RPNI) and Targeted Muscle Reinnervation (TMR) are two reinnervation techniques which have shown clear superiority over classical amputation. It is mainly due to a lower incidence of painful neuromas, residual limb pain and phantom limb pain associated with these new procedures. However, they have never been compared to each other. Neither has their effectiveness been evaluated based on patients demographics, age, sex, comorbidities (diabetes, coronary heart disease, peripheral arterial disease, chronic kidney disease, congestive heart failure), amputations cause, type of amputation, amputation level, previous surgeries and if there was or not previous nerve division into fascicles. Therefore, the objective of this systematic review and meta-analysis is to compile all the evidence to date and provide a comprehensive view of what each technique offers. Methods and design The review will be conducted according to this protocol, following the recommendations of the Cochrane Handbook for Systematic Reviews. A comprehensive electronic search will be performed in: Cochrane Register of Controlled Trials (CENTRAL), Web of Science, Scopus, PubMed and MedRixb. This review will include randomized, quasi-randomized, and observational studies written in English and Spanish. We will use Covidence for assessing all titles and abstracts identified during the literature search. Two review authors will independently assess the trial eligibility, risk of bias and extract appropriate data points. Ethics and dissemination The proposed systematic review will collect and analyse data from published studies; therefore, it raises no ethical issues. The results of the review will be disseminated by publication in a peer-review journal and submitted for presentations at conferences. Keywords: Systematic review, Meta-Analysis, Pain management, Neuroma, TMR, RPNI, Amputation. PROSPERO registration number: CRD42024617299.
Competing Interest StatementThe authors have declared no competing interest.
Clinical Protocolshttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=617299
Funding StatementThis study did not receive any funding
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
We will only use literature available data, as this is a systematic review protocol.
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Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityThis is just the protocol, we will make our data available when we collect it.
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