Health Condition 1: S629- Unspecified fracture of wrist andhand
Conditions
Interventions
Intervention1: FlexiOH: The intervention consists of treating clinically eligible forearm, wrist and hand bone fractures through immobilization with a FlexiOH immobilizer (where typically a POP or Fib
Sponsors
JC OrthoHeal Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: (1) Male or female aged 18 to 80 years (both inclusive) (2)Closed fractures of the distal forearm suitable for treatment with orthopaedic immobilization, not requiring surgical intervention (3)Subject has uncompromised cognitive function (4)General condition good and patient fit to be discharged to home after cast application (5)Subject able and willing to follow study procedures and precautions
Exclusion criteria
Exclusion criteria: (1)Wounds with whose care cast will interfere (2)Known nitrile rubber allergy (3)Any other skin condition with whose care cast will interfere or which will confound the assessment of the skin impact of the cast (4)Pathological fracture (5)Any other significant risk factor for delayed union, mal union, non-union
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To evaluate patient comfort & satisfaction during treatment Timepoint: Day 0 , 14, 42, 49;To evaluate ease of precise application & removalTimepoint: Day of application & removal | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of FlexiOH in timely achieving intended bone fracture healing outcomes, radiologically and functionally. To evaluate the safety and skin impact of the FlexiOHTimepoint: Day 0 , 14, 42, 49 | — |
Countries
India
Contacts
Public ContactDr Avijit Bansal
Mansi Hospital
Outcome results
None listed