Muscle Connective Tissue in Limb Development and Disease
2 other identifiers
observational
150
1 country
5
Brief Summary
The objective of this work is to understand how the disruption of the muscle connective tissue contributes to the limb soft-tissue defects in radial dysplasia. In parallel, the researchers will investigate the role of muscle connective tissue in normal limb development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2016
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedStudy Start
First participant enrolled
February 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2036
ExpectedAugust 27, 2025
August 1, 2025
10 years
November 16, 2015
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Characterisation of muscle connective tissue derivatives - structure
The characterization of any structural difference in tissue organisation within muscle connective tissue derivatives, comparing normal control patients to patients with radial dysplasia.
3 years
Characterisation of muscle connective tissue derivatives - function
The characterization of any functional difference in gene expression within muscle connective tissue derivatives, comparing normal control patients to patients with radial dysplasia.
3 years
Secondary Outcomes (2)
Identification of biomarker(s).
3 years
Identification of muscle connective tissue progenitor-cell pool.
3 years
Study Arms (2)
Radial dysplasia patients
Recruited participants will have 2-3 small tissue biopsy samples taken during 1-2 of their planned reconstructive surgical procedures for radial dysplasia, whilst under general anaesthesia in the operating theatre. Samples will be taken by scalpel or scissors, by the operating surgeon, from within the surgical site in the forearm and hand. The skin incision and deep dissection will have to be made as part of the normal course of reconstructive surgery, regardless of participation in this study.
Control patients
Recruited participants will have 2-3 small tissue biopsy samples taken during their planned reconstructive surgery for hand trauma, whilst under general anaesthesia in the operating theatre. Samples will be taken by scalpel or scissors, by the operating surgeon, from within the surgical site in the forearm and hand. The skin incision and deep dissection will have to be made as part of the normal course of reconstructive surgery, regardless of participation in this study.
Interventions
Eligibility Criteria
Cases - Any patient attending Great Ormond Street Hospital or Guy's and St Thomas' Hospital for reconstructive hand surgery. Controls - Any patient attending Great Ormond Street Hospital, Guy's and St Thomas' Hospital Oxford University Hospitals, Chelsea and Westminster or the Royal Free Hospital for reconstructive hand surgery.
You may qualify if:
- Patients with a clinical diagnosis of radial dysplasia, requiring reconstructive surgery
- Either sex
- Informed (parental) consent to participate
You may not qualify if:
- Patients with a clinical diagnosis of radial dysplasia, but not requiring reconstructive surgery
- Patients with a diagnosis other than radial dysplasia
- Patients with extensive previous scarring to their forearm and hand.
- Patients with a significant pathological skin or soft tissue lesion at the donor site.
- Controls
- Patients with an injury requiring reconstructive surgery
- Either sex
- Informed (parental) consent to participate
- Patients with extensive previous scarring to their forearm and hand.
- Patients with a significant pathological skin or soft tissue lesion at the donor site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Oxford University Hospitals
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Guy's and St Thomas' Hospital
London, SE1 7EH, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH, United Kingdom
Related Links
Biospecimen
Tissue biopsies measuring no more than 5 x 10 mm, consisting of muscle, muscle connective tissue, tendon, fat and skin, or a combination of the above, and / or; Tissue normally discarded during the patient's routine reconstructive hand surgery.
Study Officials
- STUDY CHAIR
Malcolm Logan, PhD
King's College London
- PRINCIPAL INVESTIGATOR
Branavan Sivakumar, FRCS(Plast)
Great Ormond Street Hospital for Children NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Gill Smith, FRCS(Plast)
Great Ormond Street Hospital for Children NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
George Murphy, PhD FRCS
Great Ormond Street Hospital for Children NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Lucy Cogswell, FRCS(Plas)
Oxford University Hospitals
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2015
First Posted
November 20, 2015
Study Start
February 20, 2016
Primary Completion
February 1, 2026
Study Completion (Estimated)
August 1, 2036
Last Updated
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share