BADAL X™ Safety and Effectiveness

BADAL X: 5-year follow-up on performance and safety

Dr. R. Atallah et al., in ‘Bone and Joint Journal’, April 2025

A single-center study at the Radboud University Medical Center in the Netherlands

Results

  1. Implant survival: 94.2%
  2. Performance: Prosthesis use improved by 58%,
    Quality of life (QTFA total score) improved by 68%.

Patient group

69 people with transfemoral amputations and 21 people with transtibial amputations
Including:
13% of people with a dysvascular amputation cause


53 people received a standard femoral stem (2 bilaterally)


16 people received a short femoral stem (1 bilaterally)


21 people received a tibial stem (1 bilaterally)

Statistics

Comparison of implant survival rates of bone anchorage systems in the EU:

BADAL X (OTN Implants, NL): 94.2% (this study; Atallah et al., BJJ, 2025)
OPRA (Integrum, SE): 92% (Branemark et al., J Am Acad Orthop Surg, 2019)
Endo Exo (Eska/Orthodynamics, DE): 90% (Reetz et al., JBJS Am, 2020)

Improving prosthetic use:

58% (52.7 points at baseline with stem prosthesis, up to 83.4 points after 5 years of FU with BADAL X)

Improvement in quality of life (QTFA total score):

68% (39.5 points at baseline with stem prosthesis, up to 66.6 points after 5 years of FU with BADAL X)