Randomised trial comparing results of two surgical procedures in high grade radial club hand with an insight into the pathology of radial club hand
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Radial Club Hand
- Registration Number
- CTRI/2013/07/003806
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br> <br/ ><br>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. <br/ ><br>Timepoint: 1. At first presentation <br/ ><br>2. Immediately before surgery <br/ ><br>3. Immediately after surgery <br/ ><br>4. Post operative 3 months <br/ ><br>5. Post operative 6 months <br/ ><br>6. Post operative 12 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method Age,Sex,Anomalies,Laterality,dominance,Heikel type,Thumb condition,casts required preop <br/ ><br>clin. forearm length,arm length,hand forearm angle <br/ ><br>rad. forearm length,arm length,hand forearm angle ap view,hand forearm angle lat view,ulnar bow ap view, lateral view <br/ ><br>total angulation,elbow,wrist, digital ROM <br/ ><br>Ability to grasp and release objects <br/ ><br>Complications,Ms. fibre type <br/ ><br>Type 1 fibre predom. <br/ ><br>Type 1,type 2 ms. fibre <br/ ><br>myofibroblasts ,mast cells,PDGF,Desmin,SMA,Electron microscopic findingsTimepoint: 1. At first presentation <br/ ><br>2. Immediately before surgery <br/ ><br>3. Immediately after surgery <br/ ><br>4. Post operative 3 months <br/ ><br>5. Post operative 6 months <br/ ><br>6. Post operative 12 months