Muscle Connective Tissue in Limb Development and Disease
NCT ID: NCT02611089
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2016-02-20
2036-08-31
Brief Summary
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Detailed Description
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The investigators have previously shown, in an experimental mouse model of radial dysplasia, the underlying soft tissue problem is a change in the muscle connective tissue and its derivatives, causing abnormal soft-tissue patterning. The investigators wish to expand this work into the investigators' patient population by comparing samples of post-natal muscle connective tissue derivatives from radial dysplasia patients with control samples.
The investigators will ask patients undergoing corrective hand surgery to let the investigators take small tissue samples during their planned operations. The investigators will also ask patients having other forms of hand surgery, such as surgery for hand injuries, to let the investigators take similar samples for comparison. In either case, their scar and peri-operative treatment will be unchanged. The investigators will examine the tissue samples in the investigators' laboratory to look for changes in tissue architecture, cellular composition, cell signalling, and how they behave when grown in culture. The investigators will also make attempts to derive cell lines from biopsy samples to use in further studies, exploring cellular phenotype and functional capacity.
Simultaneously, the investigators will look at the long-term surgical outcomes and the range of genetic changes in the investigators' patient population. Eligible patients will be referred for consideration in the (separate) 100,000 genome project; this should further expand the investigators' knowledge of the genetic changes underlying limb anomalies. The ability to combine data on genotype, long-term phenotype and soft tissue changes will give a comprehensive overview of the condition. The investigators expect this to lead to a better understanding of patient subgroups, and to provide a rational basis for improved treatment approaches.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
Tissue biopsy
Sampling of tissue as described.
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.
Tissue biopsy
Sampling of tissue as described.
Interventions
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Tissue biopsy
Sampling of tissue as described.
Eligibility Criteria
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Inclusion Criteria
* Either sex
* Informed (parental) consent to participate
* Patients with an injury requiring reconstructive surgery
* Either sex
* Informed (parental) consent to participate
Exclusion Criteria
* 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 extensive previous scarring to their forearm and hand.
* Patients with a significant pathological skin or soft tissue lesion at the donor site.
ALL
No
Sponsors
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Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Royal Free Hospital NHS Foundation Trust
OTHER
Chelsea and Westminster NHS Foundation Trust
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Malcolm Logan, PhD
Role: STUDY_CHAIR
King's College London
Branavan Sivakumar, FRCS(Plast)
Role: PRINCIPAL_INVESTIGATOR
Great Ormond Street Hospital for Children NHS Foundation Trust
Gill Smith, FRCS(Plast)
Role: PRINCIPAL_INVESTIGATOR
Great Ormond Street Hospital for Children NHS Foundation Trust
George Murphy, PhD FRCS
Role: PRINCIPAL_INVESTIGATOR
Great Ormond Street Hospital for Children NHS Foundation Trust
Lucy Cogswell, FRCS(Plas)
Role: PRINCIPAL_INVESTIGATOR
Oxford University Hospitals
Locations
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Oxford University Hospitals
Oxford, Oxfordshire, United Kingdom
Royal Free Hospital
London, , United Kingdom
Guy's and St Thomas' Hospital
London, , United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, , United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Lucy Cogswell, FRCS Plast
Role: primary
Provided Documents
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Document Type: Study Protocol
Related Links
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Study website - for version control \& distribution of patient information leaflets / consent forms.
Other Identifiers
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15/LO/2085
Identifier Type: OTHER
Identifier Source: secondary_id
14SG01
Identifier Type: -
Identifier Source: org_study_id
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