A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation

A prospective study of 51 patients

R. Brånemark, Ö. Berlin, K. Hagberg, P. Bergh, B. Gunterberg, B. Rydevik

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Abstract

Patients with transfemoral amputation (TFA) often experience problems related to the use of socket-suspended prostheses. The clinical development of osseointegrated percutaneous prostheses for patients with a TFA started in 1990, based on the long-term successful results of osseointegrated dental implants.

Between1999 and 2007, 51 patients with 55 TFAs were consecutively enrolled in a prospective, single-centre non-randomised study and followed for two years. The indication for amputation was trauma in 33 patients (65%) and tumour in 12 (24%). A two-stage surgical procedure was used to introduce a percutaneous implant to which an external amputation prosthesis was attached. The assessment of outcome included the use of two self-report questionnaires, the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) and the Short-Form (SF)-36.

The cumulative survival at two years’ follow-up was 92%. The Q-TFA showed improved prosthetic use, mobility, global situation and fewer problems (all p < 0.001). The physical function SF-36 scores were also improved (p < 0.001). Superficial infection was the most frequent complication, occurring 41 times in 28 patients (rate of infection 54.9%). Most were treated effectively with oral antibiotics. The implant was removed in four patients because of loosening (three aseptic, one infection).

Osseointegrated percutaneous implants constitute a novel form of treatment for patients with TFA. The high cumulative survival rate at two years (92%) combined with enhanced prosthetic use and mobility, fewer problems and improved quality of life, supports the ‘revolutionary change’ that patients with TFA have reported following treatment with osseointegrated percutaneous prostheses.

Cite this article: Bone Joint J 2014;96-B:106–13.

Footnotes

  • RB is part time employed by the Integrum company.

    No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.

    This article was primary edited by S. P. H. Hughes and first-proof edited by J. Scott.

  • Supplementary material. A table detailing all adverse events encountered during the study is available with the electronic version of this article on our website www.bjj.boneandjoint.org.uk. A further opinion by R. Grimer is available with the electronic version of this article on our website at www.boneandjoint.org.uk/site/education/further_op

  • Supplementary video. Two videos demonstrating this system are available with the electronic version of this article.

  • Received February 25, 2013.
  • Accepted August 6, 2013.
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