title: Are Complications Associated With the Repiphysis(®) Expandable Distal Femoral Prosthesis Acceptable for Its Continued Use?
abstract: BACKGROUND
  Reconstruction of the distal femur after resection for malignant bone tumors in skeletally immature children is challenging. The use of megaprostheses has become increasingly popular in this patient group since the introduction of custom-made, expandable devices that do not require surgery for lengthening, such as the Repiphysis(®) Limb Salvage System. Early reports on the device were positive but more recently, a high complication rate and associated bone loss have been reported.
  
  
  OBJECTIVE
  We asked: (1) what are the clinical outcomes using the Musculoskeletal Tumor Society (MSTS) scoring system after 5-year minimum followup in patients treated with this prosthesis at one center; (2) what are the problems and complications associated with the lengthening procedures of this implant; and (3) what are the specific concerns associated with revision of this implant?
  
  
  METHODS
  At our institute, between 2002 and 2007, the Repiphysis(®) expandable prosthesis was implanted in 15 children (mean age, 8 years; range, 6-11 years) after distal femoral resection for malignant bone tumors. During this time, the general indication for use of this implant was resection of the distal femur for localized malignant bone tumors in pediatric patients. Alternative techniques used for this indication were modular prosthetic reconstruction, massive (osteoarticular or intercalary) allograft reconstruction, or rotationplasty. Age and tumor extension were the main factors to decide on the surgical indication. Of the 15 patients who had this prosthesis implanted during reconstruction surgery, five died with the implant in situ or underwent amputation before 5 years followup and the remaining 10 were evaluated at a minimum of 5 years (mean, 104 months; range, 78-140 months). No patients were lost to followup. These 10 patients were long-term survivors and underwent the lengthening program. They were included in our study analysis. The first seven lengthening procedures were attempted in an outpatient setting; however, owing to pain and burning sensations experienced by the patients, the procedures failed to achieve the desired lengthening. Therefore, other procedures were performed with the patients under general anesthesia. We reviewed clinical data at index surgery for all 15 patients. We further analyzed the lengthening procedures, implant survival, radiographic and functional results, for the 10 long-term survivors. Functional results were assessed according to the MSTS scoring system. Complications were classified according to the International Society of Limb Salvage (ISOLS) classification system.
  
  
  RESULTS
  Nine of the 10 survivors underwent revision of the implant for mechanical failure. They had a mean MSTS score of 64% (range, 47%-87%) before revision surgery. At final followup the 10 long-term surviving patients had an average MSTS score of 81% (range, 53%-97%). In total, we obtained an average lengthening of 39 mm per patient (range, 17-67 mm). Exact expansion of the implant was unpredictable and difficult to control. Nine of 10 of the long-term surviving patients underwent revision surgery of the prosthesis-eight for implant breakage and one for stem loosening. At revision surgery, six patients had another type of expandable prosthesis implanted and three had an adult-type megaprosthesis implanted. In five cases, segmental bone grafts were used during revision surgery to compensate for loss of bone stock.
  
  
  CONCLUSIONS
  We could not comfortably expand the Repiphysis(®) prosthesis in an outpatient setting because of pain experienced by the patients during the lengthening procedures. Furthermore, use of the prosthesis was associated with frequent failures related to implant breakage and stem loosening. Revisions of these procedures were complex and difficult. We no longer use this prosthesis and caution others against the use of this particular prosthesis design.
  
  
  METHODS
  Level IV, therapeutic study.
authors.affiliation: Department of Orthopaedics - Musculoskeletal Oncology, Istituto Ortopedico Rizzoli (IOR) Clinica 3, Via Pupilli 1, 40136, Bologna, Italy, eric.staals@ior.it.
authors.forename: Eric L
authors.initials: EL
authors.lastname: Staals
authors.forename: Marco
authors.initials: M
authors.lastname: Colangeli
authors.forename: Nikolin
authors.initials: N
authors.lastname: Ali
authors.forename: José M
authors.initials: JM
authors.lastname: Casanova
authors.forename: Davide M
authors.initials: DM
authors.lastname: Donati
authors.forename: Marco
authors.initials: M
authors.lastname: Manfrini
mesh_terms: D000367:Age Factors; D001696:Biomechanical Phenomena; D001852:Bone Lengthening / Q000009:adverse effects* / Q000295:instrumentation*; D016025:Bone Transplantation; D002648:Child; D005260:Female; D005266:Femoral Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D005269:Femur / Q000000981:diagnostic imaging / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007558:Italy; D023821:Limb Salvage; D008297:Male; D010027:Osteotomy; D010149:Postoperative Pain / Q000175:diagnosis / Q000209:etiology* / Q000601:surgery; D018579:Patient Selection; D011474:Prosthesis Design; D011475:Prosthesis Failure; D019919:Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation*; D011859:Radiography; D012086:Reoperation; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome