Nerve Composition of Human Lumbar Dorsal Primary Rami and... | NCT05091112

Studies
Nerve Composition of Human Lumbar Dorsal Primary Rami and Its Medial Branch

NCT05091112

Sponsor

University of Aberdeen

Status

Recruiting

Last Update Posted

Dec 24, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Lumbar Facet Arthrosis
Nerve Degeneration

Interventions

Spinal surgery
Histology

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 8, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 8, 2021

First Submission Date that Met QC Criteria

Oct 22, 2021

First Posted Date

Oct 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2024

Last Update Posted Date

Dec 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to understand the composition of the nerves supplying the facet joints in low back.

Detailed Description

After written informed consent, the nerves supplying the facet joints - lumbar dorsal rami and its medial branches, will be harvested when they are exposed during spinal surgery. These nerves will be fixed, washed and further dissected to enable smaller sections. The cut section will be stained and subjected to analysis of overall cross-sectional area and presence of connective tissue sheaths under light microscope.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active group		Patients who are scheduled to undergo lumbar spinal surgery and fulfill the inclusion and exclusion criteria	Procedure: Spinal surgery Other: Histology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spinal surgery	Procedure	In participants who undergo elective lumbar spinal surgery and consented for research, the medial branch and dorsal rami will be harvested for histological analysis.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nerve Histology	Percentage of nerves containing more than 50% sensory fibres in lumbar dorsal rami/medial branches to assess whether they are sensory or motor nerves	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be aged 18 or over
be able to give informed consent
scheduled to undergo lumbar spinal surgery

Exclusion Criteria:

Children under 18 years old
Vulnerable adults
Adults with incapacity
Inability to provide informed consent
History of previous spinal surgery
history of previous RF ablation for low back pain
has COVID-19 or displaying symptoms of COVID-19

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will be the cohort of patients who are scheduled to undergo lumbar spinal surgery. The potential population will be identified from the patients who are being invited for the surgery. All prospective participants will be sent an invitation letter and Participant Information Sheet along with their the clinical appointment letters.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Saravanakumar Kanakarajan, MD FRCA	Contact	00 44 1224 553237		saravanakumark@abdn.ac.uk

Overall Officials

Name	Affiliation	Role
Saravanakumar Kanakarajan, MD FRCA	NHS Grampian	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Woodend Hospital	Recruiting	Aberdeen	Scotland	AB15 6XS	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009410	Nerve Degeneration

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016626	Shadowing Technique, Histology

Ancestor Terms

ID	Term
D013194	Staining and Labeling
D016591	Histocytological Preparation Techniques
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques

Browse Leaves

Not provided

Browse Branches

Not provided