BADAL X In- and Exclusion criteria

Inclusion Criteria:

  • Lower limb amputation (transtibial and transfemoral)
  • Difficulties with the Socket Attached Artificial Limb because of problems such as:
    • Pain
    • A short stump preventing the use of socket prosthesis 
    • Volume fluctuation in the stump
    • Soft tissue scarring
    • Recurrent skin infections and ulcerations in the socket contact area
    • Vulnerable skin
    • Socket retention problems due to excessive perspiration
    • Impaired sitting comfort
    • Limited standing and walking possibilities with socket prosthesis 

 

Exclusion Criteria:

  • Atypical skeletal anatomy 
    • Skeletal dimensions outside defined interval
    • Developmental anomalies
    • Deformities 
  • Radiation therapy or chemotherapy at target limb with past 18 months
  • Concurrent diseases:
    • Severe peripheral vascular disease
    • Diabetic mellitus with complications
    • Skin infection of the residual limb
    • Active infection or dormant bacteria
    • Local or systemic inflammatory disease
    • Immunocompromised
    • History of allograft bone transplant in ipsilateral limb
  • Cardiorespiratory conditions that limit current and future potential for walking
  • Comorbidities in contralateral limb that would limit bilateral weight bearing and walking
  • Pregnant or intending to become pregnant during treatment periodt
  • Cognitive impairment that limits adherence to medical instructions