Saluran saraf biokejuruteraan dan balutan untuk pembaikan saraf periferi anggota atas
Información
- DOI:
- https://doi.org/10.1002/14651858.CD012574.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 07 diciembre 2022see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Neuromuscular
- Copyright:
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- Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
SET, MR, AH, and PK conceived the review.
SET and NN drafted the protocol, and MR, AH, PK, LD, and MW revised the draft. All authors approved publication of the protocol.
All authors developed the search strategy with assistance from Cochrane team.
SET and NN: screened titles and abstracts and full‐text reports performed data extraction and assessed risk of bias.
AH, MR, or PK: resolved differences in study selection and risk of bias assessment.
NN entered data into Review Manager 5 and SET checked data entry.
All authors commented on and approved the final draft of the review.
Sources of support
Internal sources
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No sources of support provided
External sources
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Medical Research Council, UK
Clinical Research Training Fellowship (SET)
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National Institute of Health Research (NIHR), Queen Square Centre for Neuromuscular Diseases, UK
This project was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure funding to Cochrane Neuromuscular. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health. Cochrane Neuromuscular is also supported by the Queen Square Centre for Neuromuscular Diseases.
Declarations of interest
SET: recently complete PhD clinical research training fellowship (MRC 70085). She collaborates with NHS Blood & Transplant (NHSBT) on peripheral nerve repair projects with no financial links and no current research output. She holds a Tenovus Scotland Grant actively researching nerve regeneration strategies in collaboration with the Centre for the Cellular Microenvironment at the Advanced Research Centre, University of Glasgow. She works clinically on surgery of the peripheral nerve and has published and presented translationally relevant research on the topic. She serves on the British Surgical Society of the Hand (BSSH) Overseas Trainee Committee as research lead and contributes to global research in the field of upper limb surgery.
NYBN: is an Orthopaedic Surgery Registrar, NHS Greater Glasgow and Clyde.
MOR: University Of Glasgow (MRC Fellowship (MR/L017741/1) held by Suzanne Thomson: grant/contract) (July 2014 to July 2017). He has given talks on multiple occasions in the UK (Strathclyde, University College London, Aberdeen, King's College London), posted on Twitter (@morenorse), and contributed to scientific publications and commentary. He is a member of the British Neuroscience Association, British Society for Cell Biology and of the Federation of European Neuroscience Societies.
PJK: his former institution is the patent holder for a peripheral nerve growth conduit (patent US20160082149A1) and a peripheral nerve growth scaffold including poly‐E‐caprolactone (patent GB2490269A), for which he has received no personal payment.
LBD: has received payment from AxoGen for membership of an advisory board on a practical course in nerve repair and membership of a Data Safety and Monitoring Board (November 2019). LBD was a member of an EU consortium, financially supported by an EU grant, in which Medovent AG (manufacturer of chitosan nerve guides) was also a member. He has received no financial support from this company. Medovent Inc provides chitosan conduits in the project. He has an active research collaboration with Vibrosense Inc concerning evaluation of vibrotactile sense (Dahlin 2015), which is supported by the foundation VINNOVA, Sweden. He has received no financial support from the company. He has been consultant for AxoGen Inc, Gainsville, Florida, USA 2003 to 2004. AxoGen Inc produce Avance (R) Nerve Graft, Axoguard(R) Nerve Connector, and Axoguard(R) Nerve Protector. LBD has been a principal investigator in a clinical trial of Neurocap(R) (Protect Neuro) for neuroma treatment financed by Polyganics B.V. LBD is also a board member of Scania Hand Center AB. He was involved in an included study that had university and Swedish Medical Research Council funding (Lundborg 2004).
MW: works as a hand surgeon at Umeå University Hospital. He was involved in a study eligible for the review funded as previously in receipt of an AstraTech research funding for the investigation of poly(R)‐3‐hydroxybutyrate (PHB) as a material for use in peripheral nerve repair from 1992 to 2008, a consulting fee 2002 to 2008, and funding for a prospective randomised clinical controlled trial of the use of PHB material for wraparound repair of peripheral nerve injuries. The research has been concluded and there are no ongoing connections by AstraTech (Aberg 2009).
AMH: is in receipt of a stipend from the British Association of Plastic and Reconstructive Surgery (BAPRAS) for his role as Editor of the Journal of Plastic Reconstructive & Aesthetic Surgery (JPRAS). He receives payment from BMI and Nuffield hospitals for small volume private practice as a Consultant Hand & Plastic Surgeon, which (rarely) includes peripheral nerve reconstruction. His institution receives grants from the following: NHSBT – provision of clinical and academic advice on product development (potential decellularised nerve allograft product) and research options, and ethical/regulatory dataset requirements; Ossur – clinical trial lead, contract start January 2021; and Bobby Charlton Foundation – clinical trial lead for the first in human testing of a nanokicked osteogenic stem cell therapy. He has worked as a hand and plastic surgeon in the National Health Service, New Zealand, and Sweden for over 20 years, as a consultant since around 2006. His honorary post in the University of Glasgow is focused on peripheral nerve injury and tissue engineering research. He has subspecialty clinical practice in major peripheral nerve injury (adult and paediatric). He has published, presented, supervised research, and given expert advice in the field of peripheral nerve regeneration and reconstruction as part of normal clinical and academic roles. He is a member of British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) and the BSSH, in addition to other professional bodies. BSSH and, to a lesser extent, BAPRAS have been actively involved in the field of peripheral nerve research, and AMH was involved in the BSSH‐funded James Lind Alliance project to identify research priorities, which included the field of peripheral nerve injury.
Acknowledgements
The review authors would like to acknowledge the support of the Medical Research Council, which funded the lead author's PhD Fellowship (L70085). We would also like to acknowledge the ongoing support throughout the review process of Ruth Brassington, Cochrane Neuromuscular and Information Specialists of Cochrane Neuromuscular, Angela Gunn and Farhad Shokraneh, who developed the search strategy in consultation with the review authors.
The Methods section of this review is based on a template developed by Cochrane Neuromuscular from an original created by the Cochrane Airways Group.
Version history
| Published | Title | Stage | Authors | Version |
| 2022 Dec 07 | Bioengineered nerve conduits and wraps for peripheral nerve repair of the upper limb | Review | Suzanne E Thomson, Nigel YB Ng, Mathis O Riehle, Paul J Kingham, Lars B Dahlin, Mikael Wiberg, Andrew M Hart | |
| 2017 Mar 08 | Bioengineered nerve conduits and wraps for peripheral nerve repair of the upper limb | Protocol | Suzanne E Thomson, Nigel YB Ng, Mathis O Riehle, Paul J Kingham, Lars B Dahlin, Mikael Wiberg, Andrew M Hart | |
Differences between protocol and review
We made the following changes from our protocol (Thomson 2017).
Types of studies. Our protocol described plans for narrative discussion of large cohort studies if RCTs were unavailable. We identified RCTs and this was not necessary.
No subgroup analysis was possible due to heterogeneity, methodological variation, and relatively low participant numbers per trial. There were no instances of three or more treatment groups per trial and there were no cases when participants were randomised to one graft and an alternative used for a second graft.
We prespecified 24 months' follow‐up for the primary outcomes in our summary of findings tables and also 12‐month time point for secondary outcomes. We changed them to '24 months or more' and '12 to 24 months' to allow for extended follow‐up times, given their relevance for decision‐makers, and to maximise the use of data from 12 to 24 months. In the protocol, we specified a minimum follow‐up duration of 12 months in included studies, which we applied in the review. In keeping with this, we made a correction to the outcomes section in the review to remove references to outcome measurement at six months.
The review protocol specified that we would report serious adverse events. Only one study made the distinction between serious and non‐serious device‐related adverse events (Aberg 2009), and did not find either. Other studies did not make a distinction between serious and non‐serious adverse events. We reported all adverse events mentioned in the included studies in order to adequately capture benefits and harms.
Data on cost of bioengineered devices were complex and we did not report them in the summary of findings table as planned in the protocol. Instead, the authors provided detail in a separate table, for clarity of presentation.
We removed a planned sensitivity analysis on the advice of the group methodologist: 'Repeat the analysis excluding any large studies to establish how much they dominate the results.'
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
Medical Subject Headings Check Words
Humans;
PICO
Study PRISMA flow diagram.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Forest plot of comparison: 1 Repair using bioengineered device versus standard nerve repair, outcome: 1.5 Integrated functional outcome, assessed with Rosén Model Instrument.
Forest plot of comparison: 1 Repair using bioengineered device versus standard nerve repair, outcome: 1.9 Adverse events.
Forest plot of comparison: 1 Repair using bioengineered device versus standard nerve repair, outcome: 1.10 Device removal or revision.
Comparison 1: Repair using bioengineered device versus standard nerve repair, Outcome 1: Sensory recovery at ≥ 24 months
Comparison 1: Repair using bioengineered device versus standard nerve repair, Outcome 2: Muscle strength, assessed with BMRC motor grading at 12–24 months
Comparison 1: Repair using bioengineered device versus standard nerve repair, Outcome 3: Motor Rosén at 12–24 months
Comparison 1: Repair using bioengineered device versus standard nerve repair, Outcome 4: Sensory recovery, assessed with BMRC sensory grading at 12–24 months
Comparison 1: Repair using bioengineered device versus standard nerve repair, Outcome 5: Integrated functional outcome, assessed with Rosén Model Instrument
Comparison 1: Repair using bioengineered device versus standard nerve repair, Outcome 6: Touch threshold, measured by Semmes‐Weinstein Monofilament
Comparison 1: Repair using bioengineered device versus standard nerve repair, Outcome 7: Cold intolerance
Comparison 1: Repair using bioengineered device versus standard nerve repair, Outcome 8: Sensory nerve action potential (SNAP)
Comparison 1: Repair using bioengineered device versus standard nerve repair, Outcome 9: Adverse events
Comparison 1: Repair using bioengineered device versus standard nerve repair, Outcome 10: Device removal or revision
| Repair using bioengineered devices versus standard techniques | ||||||
| Patient or population: people undergoing peripheral nerve repair of the upper limb | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with standard repair | Risk with bioengineered devices | |||||
| Muscle strength at ≥ 24 months | Not reported | |||||
| Sensory recovery at ≥ 24 months | The mean sensory recovery assessed with BMRC sensory grading in the standard repair group at 2 years was 2.75 points | The mean sensory recovery assessed with BMRC sensory grading at 2 years with bioengineered devices was 0.03 points higher | — | 28 (1 RCT) | ⊕⊝⊝⊝ | There may be no difference in therapeutic effect on sensory recovery with bioengineered devices compared to standard repair at 24 months, but the evidence is very uncertain. |
| Integrated functional outcome at ≥ 24 months Follow‐up: 2 years | The mean integrated functional outcome (RMI score) in the standard repair group was 1.875 | The mean integrated functional outcome (RMI score) with bioengineered devices was 0.17 lower (0.38 lower to 0.05 higher) | — | 60 | ⊕⊕⊝⊝ | There may be little or no difference in RMI with bioengineered devices compared to standard repair at 24 months to 5 years. At 5 years, the RMI may be slightly better after device repair than standard repair (MD 0.23, 95% CI 0.07 to 0.38; 1 RCT, 28 participants). |
| Touch threshold (score 0–1, where higher score is better) | Mean touch threshold score in the standard repair group was 0.81 | The mean touch threshold score with bioengineered devices was 0.01 higher (0.06 lower to 0.08 higher) | — | 32 (1 RCT) | ⊕⊝⊝⊝ | There may be little or no difference in touch threshold measured by Semmes‐Weinstein monofilament test with bioengineered nerve conduits compared to standard repair at 24 months. Semmes‐Weinstein monofilament test contributed to RMI data in 2 studies at 12 months. 1 further study planned to use this outcome measure but found it to be imprecise and did not report data. |
| Impact on daily living | No studies employed DASH PROM. | |||||
| Adverse events assessed as: adverse events (serious and non‐serious) Follow‐up: range 3 months to 5 years | 10 per 1000 | 68 per 1000 (17 to 280) | RR 7.15 (1.74 to 29.42) | 213 participants | ⊕⊝⊝⊝ | Use of bioengineered devices may increase adverse events compared to standard repair techniques, but the evidence is very uncertain. 2 studies included in this analysis had no adverse events. 1 study provided no information on adverse events in the standard repair group. |
| Specific serious adverse events: further surgery (device removal or revision)i assessed as: any unplanned secondary surgery to remove device Follow‐up: range 3 months to 5 years | 12/129 devices required further surgery (device removal) in the bioengineered devices group; 0/127 procedures required further surgery in the standard repair group | RR 7.61 (1.48 to 39.02) | 256 repairs | ⊕⊝⊝⊝ | The use of bioengineered devices may require more revision (device removal or revision) than standard repair but the evidence is uncertain. Unplanned removal of 12/44 devices (1/21 poly(DL‐lactide‐caprolactone) (Neurolac) devices, 8/17 silicone devices and 3/6 polyglycolic acid devices. 2 studies included in this analysis required no device removal. | |
| *The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BMRC: British Medical Research Council; CI: confidence interval; DASH PROM: Disability of Arm Shoulder and Hand Patient‐Reported Outcome Measure; MD: mean difference; RCT: randomised controlled trial; RMI: Rosén Model Instrument; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded twice for imprecision, because of the very small sample size. | ||||||
| Device trade name | Material | Cost for device to repair 10 mm gap, 2 mm diameter |
|---|---|---|
| NeuroTube | Polyglycolic acid | GBP 580 exc of VAT (November 2018) |
| Neurogen PNG220 | Type I collagen | GBP 689.26 exc of VAT (Nov 2018) |
| Neurolac (Polyganics) | poly(DL‐lactide‐ε‐caprolactone) | No reply November 2018 [email protected] and info@polyganics emailed further 7 January 2019 further 18 May 2019 |
| Salubridge | Polyvinyl alcohol | No reply November 2018 [email protected] emailed further 7 January 2019 further 18 May 2019 |
| Axoguard | Porcine small intestine submucosa | USD 1000 equivalent to GBP 789.04 (April 2019) |
| Avance Axogen | Decellularised cadaveric nerve | USD 1800 equivalent to GBP 1420.28 (April 2019) |
| RevoInerv (NG02‐0203) | Porcine Type I and III collagen, bovine Type I | GBP 348 exc of VAT (January 2019) |
| exc: exclusive; GBP: Great British pounds; USD: United States dollars; VAT: value added tax. | ||
| Conduit/name | Study detail | Outcomes measured | Status | Study design |
|---|---|---|---|---|
| Registry of Avance Nerve Graft Evaluating utilization and outcomes for the Reconstruction of peripheral nerve discontinuities (RANGER) Avance, Axogen Inc. | Avance vs standard practice (epineurial suture or autologous nerve graft). Aim 5000 participants, 36 months' follow‐up | Adverse events, "improvement in function, return of meaningful recovery" | Recruiting, estimated completion December 2020, extended to December 2025 | Observational retrospective registry |
| Polynerve University of Manchester (UK) | Polynerve repair of nerve gaps 5–20 mm Aim 16 participants, 12 months' follow‐up | Adverse reactions (Clavien‐Dindo classification), 2‐PD, SWM | Recruitment complete, 17 participants, estimated completion August 2019 | Prospective observational cohort |
| Fibrin wrap or conduit University Hospital Basel (Switzerland) | Fibrin wrap or conduit vs standard practice (epineurial suture or autologous nerve graft) direct repair or > 5 mm gap digital nerves. Aim 48 participants, 6 months' follow‐up | 2‐PD, SWM, electroneurography | Recruiting, estimated completion December 2022 | Interventional case control |
| Hydrophilic polymers at repair site Vanderbilt University (Nashville, Tennessee) | Repair and topical polyethylene glycol (MiraLAX (MERCK) at repair site vs repair alone (epineurial suture or autologous nerve graft)). Within 48 hours of injury. Aim 18 participants 12 months' follow‐up | Return of nerve function as measured by BMRC classification. | Recruiting, estimated completion March 2020 | Interventional RCT |
| Reaxon Siemers, Medovent, GmBH (Germany) | Reaxon vs standard practice (epineurial suture or autologous nerve graft) < 26 mm gap digital nerves. Within 3 months of injury. Aim 76 participants, study terminated | 2‐PD, cold intolerance, Hoffmann‐Tinel‐Test, adverse reactions | Recruiting, estimated completion December 2018. January 2019 update Terminated (study was stopped due to slow participant recruitment and insufficient participant compliance) | Interventional RCT |
| Comparison of processed nerve allograft and collagen nerve cuffs for peripheral nerve repair (RECON) Axogen Inc. | Human nerve allograft vs bovine collagen repair cuff Aim 220 participants 12 months' follow‐up | 2‐PD | Recruiting Estimated completion November 2021 | Interventional RCT |
| A multicentre prospective observational study of nerve repair and reconstruction associated with major extremity trauma Johns Hopkins (Baltimore, Maryland) | Partial or complete upper extremity nerve injury, all repair types. Aim 250 participants 24 months' follow‐up | Extensive list of primary and secondary outcome measures with 2‐year follow‐up period – detail available | Active, not recruiting Estimated completion September 2022 | Prospective observational cohort |
| Chitosan nerve tube for primary repair of traumatic sensory nerve lesions of the hand (CNT) BG Unfallklinik (Frankfurt, Germany) | Chitosan nerve tube vs standard repair sensory nerves of the hands Aim 100 participants 24 months' follow‐up | 2‐PD, DASH, grip strength, range of motion, pain, cold intolerance, hypersensitivity, existence of neuromas, adverse events | Recruiting Last update July 2017 | Interventional RCT |
| Mid‐term effect observation of biodegradable conduit small gap tubulisation repairing peripheral nerve injury Peking University People's Hospital (Beijing, China) | Repair of peripheral nerve injury in the upper extremities using a biodegradable conduit Aim 150 participants 36 months' follow‐up | BMRC grading SHEN Ning‐jiang score | Active Estimated completion December 2021 | Prospective observational cohort |
| Preliminary evaluation of the clinical safety and effectiveness of the bionic nerve scaffold Xijing Hospital (China) | Preliminary evaluation of the clinical safety and effectiveness of the bionic nerve scaffold Aim 10 participants 6 months' follow‐up | 2‐PD, joint position sense and haematological tests | Recruiting Last update December 2018 | Prospective observational cohort |
| Pilot study to evaluate the reconstruction of digital nerve defects in humans using an implanted silk nerve guide Klinik für Plastische Chirurgie und Handchirurgie – UniversitätsSpital Zürich (Switzerland) | Prospective, unblinded, single‐group assignment silk nerve guide Aim 15 participants 12 months' follow‐up | Adverse events, sensory recovery 2‐PD, VAS, patient satisfaction Patient Global Impression of Change questionnaire | Recruiting Estimated completion March 2021 | Prospective observational cohort |
| CoNNECT (Conduit Nerve approximation versus Neurorrhaphy Evaluation of Clinical Outcome Trial): a study of sutureless nerve repair Queen Elizabeth Hospital Birmingham (UK) | Digital nerve injuries in upper limb, direct repair vs poly(DL‐lactide‐caprolactone) (Neurolac) nerve guide sutured vs Neurolac nerve guide no sutures Aim 240 participants 12 months' follow‐up | Static and moving 2‐PD, monofilament pressure testing, DASH, EQ‐5D, Tinel sign, pain, cold intolerance, hyperaesthesia, site, and quality of repair | Active Estimated completion January 2021 | Interventional RCT |
| Expanded access for single patient treatment of autologous human Schwann cells (ahSC) for peripheral nerve repair | Autologous, culture expanded Schwann cells seeded in Duragen collagen matrix used to repair a sciatic nerve defect | Not provided | Single participant study, 5 years' follow‐up | Single participant study |
| BMAC Nerve Allograft Study | Decellularised cadaveric nerve graft combined with unexpanded autologous bone marrow cells. Aim 15 participant recruitment, comparison to historical outcome measures obtained for Avance nerve graft. | Adverse events, Rosén Model Instrument, motor and sensory nerve conduction studies, pinch and grip strength, 1‐PD and 2‐PD | Recruiting | Single group, interventional clinical trial |
| 1‐PD: 1‐point discrimination; 2‐PD: 2‐point discrimination; DASH: disability of the arm, shoulder and hand; EQ‐5D: Euro‐Qol 5 Dimension; BMRC: British Medical Research Council; RCT: randomised controlled trial; SWM: Semmes‐Weinstein monofilament; VAS: visual analogue scale. | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Sensory recovery at ≥ 24 months Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | |
| 1.1.1 At 5 years | 1 | 28 | Mean Difference (IV, Fixed, 95% CI) | 0.03 [‐0.43, 0.49] |
| 1.2 Muscle strength, assessed with BMRC motor grading at 12–24 months Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.2.1 At 18 months | 1 | 11 | Mean Difference (IV, Random, 95% CI) | 0.40 [‐0.38, 1.18] |
| 1.3 Motor Rosén at 12–24 months Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.3.1 At 24 months | 2 | 60 | Mean Difference (IV, Random, 95% CI) | ‐0.09 [‐0.24, 0.05] |
| 1.3.2 At 12 months | 1 | 35 | Mean Difference (IV, Random, 95% CI) | ‐0.15 [‐0.18, ‐0.12] |
| 1.4 Sensory recovery, assessed with BMRC sensory grading at 12–24 months Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.4.1 At 18 months | 1 | 11 | Mean Difference (IV, Random, 95% CI) | 0.93 [‐0.09, 1.95] |
| 1.5 Integrated functional outcome, assessed with Rosén Model Instrument Show forest plot | 2 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | |
| 1.5.1 At 5 years | 1 | 28 | Mean Difference (IV, Fixed, 95% CI) | 0.23 [0.07, 0.38] |
| 1.5.2 At 24 months | 2 | 60 | Mean Difference (IV, Fixed, 95% CI) | ‐0.17 [‐0.38, 0.05] |
| 1.5.3 At 12 months | 2 | 65 | Mean Difference (IV, Fixed, 95% CI) | ‐2.29 [‐2.49, ‐2.09] |
| 1.6 Touch threshold, measured by Semmes‐Weinstein Monofilament Show forest plot | 2 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | |
| 1.6.1 At 24 months | 1 | 32 | Mean Difference (IV, Fixed, 95% CI) | 0.01 [‐0.06, 0.08] |
| 1.6.2 At 12 months | 2 | 65 | Mean Difference (IV, Fixed, 95% CI) | 0.05 [‐0.07, 0.17] |
| 1.7 Cold intolerance Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.7.1 At 24 months | 1 | 32 | Mean Difference (IV, Random, 95% CI) | 0.11 [‐0.08, 0.30] |
| 1.8 Sensory nerve action potential (SNAP) Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.8.1 At 24 months | 2 | 60 | Mean Difference (IV, Random, 95% CI) | ‐0.08 [‐1.89, 1.73] |
| 1.8.2 At 12 months | 2 | 61 | Mean Difference (IV, Random, 95% CI) | 0.23 [‐0.58, 1.03] |
| 1.9 Adverse events Show forest plot | 5 | 213 | Risk Ratio (M‐H, Fixed, 95% CI) | 7.15 [1.74, 29.42] |
| 1.10 Device removal or revision Show forest plot | 5 | 256 | Risk Ratio (M‐H, Fixed, 95% CI) | 7.61 [1.48, 39.02] |
