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Randomised trial comparing results of two surgical procedures in high grade radial club hand with an insight into the pathology of radial club hand

Randomised trial comparing results of radialisation and centralisation procedures in high grade radial club hand with an insight into the histopathology of radial club hand - RCH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/07/003806
Enrollment
17
Registered
2013-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Radial Club Hand

Interventions

Intervention1: Radialisation: Surgical Procedure: It is a comparative trial between two surgical procedures used for the treatment of the same disease and hence it is not a single arm trial. Also sinc

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with high grade radial club hand (Heikel grade 3 and 4 2. Patients willing to give consent for this study.

Exclusion criteria

Exclusion criteria: Patients with previously operated radial club hand. 2. Low grade radial club hand (Heikel grade 1 and 2)(33) 3. Patients with other associated systemic abnormalities rendering the patient unfit for general anaesthesia. 4. Patients who have adapted to the deformity 5. Patients not willing to give consent for this study.

Design outcomes

Primary

MeasureTime frame
1. To study the clinical, radiological and functional outcome following Centralization and Radialization procedures in high grade (Heikel grade 3 and 4) radial club hand. 2. To study the histopathological changes (using light microscopy with immunohistochemistry and electron microscopy) in muscle and connective tissue in patients with radial club hand. Timepoint: 1. At first presentation 2. Immediately before surgery 3. Immediately after surgery 4. Post operative 3 months 5. Post operative 6 months 6. Post operative 12 months—

Secondary

MeasureTime frame
Age,Sex,Anomalies,Laterality,dominance,Heikel type,Thumb condition,casts required preop clin. forearm length,arm length,hand forearm angle rad. forearm length,arm length,hand forearm angle ap view,hand forearm angle lat view,ulnar bow ap view, lateral view total angulation,elbow,wrist, digital ROM Ability to grasp and release objects Complications,Ms. fibre type Type 1 fibre predom. Type 1,type 2 ms. fibre myofibroblasts ,mast cells,PDGF,Desmin,SMA,Electron microscopic findingsTimepoint: 1. At first presentation 2. Immediately before surgery 3. Immediately after surgery 4. Post operative 3 months 5. Post operative 6 months 6. Post operative 12 months—

Countries

India

Contacts

Public ContactSamarth Mittal

All India Institute of Medical Sciences (AIIMS)

prakash.kotwal@gmail.com9868397101

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026