- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07805902
Anatomical Probability Model for Tibial and Peroneal Motor Entry Points
Study Overview
Status
Intervention / Treatment
Detailed Description
Hyperselective neurectomy requires accurate localization of terminal motor branches and their neuromuscular entry points in the lower leg. This descriptive cadaveric study was designed to establish proportional anatomical reference zones for motor branches of the tibial, superficial peroneal, and deep peroneal nerves.
Fresh-frozen adult lower-limb specimens without prior trauma or prior surgical intervention were examined. One extremity per cadaver was selected by coin toss. Standardized posterior, lateral, and anterior compartment dissections were performed to identify the tibial nerve and the common peroneal nerve, trace the superficial and deep peroneal divisions, and follow terminal motor branches to the point at which each branch entered the corresponding muscle.
For tibial nerve branches, branch location was referenced to the posterior border of the tibia at the midpoint of the proximal epiphysis. For superficial and deep peroneal branches, the proximal reference point was the most superior aspect of the fibular head on its anterior surface. The distal reference point was the point of entry into the target muscle. Total leg length was measured from the knee joint line to the ankle joint line. The motor entry point was calculated as the distance to the entry point divided by total leg length. Distributions were evaluated separately for each muscle using the Shapiro-Wilk test. Means and standard deviations were calculated, and probability intervals corresponding to mean plus or minus one standard deviation and mean plus or minus two standard deviations were used to define the most likely anatomical zones of motor branch entry. When required, logarithmic, square-root, or power transformations were used to approximate normality, with results expressed on the original proportional scale.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: MARIA F GARCIA RUEDA, MD, Orthopedist
- Phone Number: +57 3208541343
- Email: m-garciar@javeriana.edu.co
Study Locations
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Bogotá, Colombia
- entro Latinoamericano de Investigación y Entrenamiento en Cirugía Mínimamente Invasiva (CLEMI)
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Contact:
- MARIA F GARCIA RUEDA, MD, Orthopedist
- Phone Number: +573208541343
- Email: m-garciar@javeriana.edu.co
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult cadaveric specimen (age at death 18 years or older)
- Fresh-frozen lower-limb specimen made available under institutional standards for cadaveric research
- No prior trauma involving the selected lower limb
- No prior surgical intervention involving the selected lower limb
Exclusion Criteria:
- Cadaveric specimen from an individual younger than 18 years at death
- Prior trauma involving the lower limb
- Prior surgical intervention involving the lower limb
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Adult Cadaveric Lower-Limb Specimens
Twenty fresh-frozen adult lower-limb cadaveric specimens were examined.
Specimens had no prior lower-limb trauma or surgical intervention.
One extremity per cadaver was selected by coin toss and underwent standardized dissection for identification and measurement of terminal motor branches of the tibial, superficial peroneal, and deep peroneal nerves.
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Standardized posterior, lateral, and anterior compartment dissections were performed.
The tibial nerve was identified through the posterior approach.
The common peroneal nerve was identified near the biceps femoris tendon and traced to its superficial and deep divisions.
Motor branches were followed to their points of entry into the target muscles.
The location of each motor entry point was measured relative to prespecified tibial or fibular landmarks and normalized to total leg length measured from the knee joint line to the ankle joint line.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean proportional localization of motor nerve entry points by target muscle
Time Frame: Periprocedural, during the single standardized cadaveric dissection session for each specimen. 1 day
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For each terminal motor branch, the distance from the prespecified proximal bony reference point to the point at which the branch entered the target muscle was measured.
For tibial branches, the proximal reference was the posterior border of the tibia at the midpoint of the proximal epiphysis.
For superficial and deep peroneal branches, the proximal reference was the most superior aspect of the fibular head on its anterior surface.
Total leg length was measured from the knee joint line to the ankle joint line.
The motor entry point was calculated as distance to the entry point divided by total leg length and expressed as a dimensionless proportion.
For each target muscle, the mean, standard deviation, 68% probability interval (mean ±1 standard deviation), and 95% probability interval (mean ±2 standard deviations) were calculated.
Target muscles included the medial and lateral gastrocnemius, soleus, flexor digitorum longus, flexor hallucis longus, tibialis posterior, fibularis/peroneus
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Periprocedural, during the single standardized cadaveric dissection session for each specimen. 1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of motor branches identified by parent nerve and target muscle
Time Frame: Periprocedural, during the single standardized cadaveric dissection session for each specimen. 1 day
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Count of terminal motor branches arising from the tibial, superficial peroneal, or deep peroneal nerve and entering each dissected target muscle.
Results are reported as counts by parent nerve and target muscle.
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Periprocedural, during the single standardized cadaveric dissection session for each specimen. 1 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria F Garcia Rueda, MD, Orthopedist
Publications and helpful links
General Publications
- Mikalef P, Power D. The role of neurectomy in the management of spasticity of the upper limb. EFORT Open Rev. 2017 Nov 27;2(11):469-473. doi: 10.1302/2058-5241.2.160074. eCollection 2017 Nov.
- Baroncini M, Baiz H, Wavreille G, Demondion X, Maurage CA, Buisset N, Blond S, Kim HJ, Fontaine C. Anatomical bases of tibial neurotomy for treatment of spastic foot. Surg Radiol Anat. 2008 Aug;30(6):503-8. doi: 10.1007/s00276-008-0359-9. Epub 2008 May 15.
- Sindou MP, Simon F, Mertens P, Decq P. Selective peripheral neurotomy (SPN) for spasticity in childhood. Childs Nerv Syst. 2007 Sep;23(9):957-70. doi: 10.1007/s00381-007-0399-1. Epub 2007 Jun 29.
- Leclercq C, Perruisseau-Carrier A, Gras M, Panciera P, Fulchignoni C, Fulchignoni M. Hyperselective neurectomy for the treatment of upper limb spasticity in adults and children: a prospective study. J Hand Surg Eur Vol. 2021 Sep;46(7):708-716. doi: 10.1177/17531934211027499. Epub 2021 Jul 13.
- Kim SC, Kang MH, Ock JJ. Calf-contouring surgery of gastrocnemius hypertrophy: selective neurectomy of the sural nerve. Aesthetic Plast Surg. 2008 Nov;32(6):889-93. doi: 10.1007/s00266-007-9107-5.
- Abbruzzese G. The medical management of spasticity. Eur J Neurol. 2002 May;9 Suppl 1:30-4; discussion 53-61. doi: 10.1046/j.1468-1331.2002.0090s1030.x.
- Dauleac C, Sindou M, Mertens P. How I do it: selective tibial neurotomy. Acta Neurochir (Wien). 2020 Aug;162(8):1921-1923. doi: 10.1007/s00701-020-04314-9. Epub 2020 May 7.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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