SURVIVAL OF THE IMPLANTS IN PRIMARY AND SECONDARY RECONSTRUCTIONS WITH GMRS® MODULAR PROSTHESES FOR THE LOWER LIMB: COMPLICATIONS, FUNCTIONAL RESULTS AND A COMPARATIVE STATISTICAL ANALYSIS

Abstract

Purpose of this study is to analyze the results of a modular reconstructive tumor prosthesis for the lower limb (GMRS^®) with a comparative statistical analysis of primary and secondary implants.

Material and methods: From October 2003 to September 2007 at Rizzoli 161 GMRS^® prostheses were implanted, most after resection of osteosarcoma (94 cases, 58%). It is a modular system with a rotating hinge mechanism for the knee, cemented and uncemented stems, in titanium and chromium-cobalt-molybdenum, curved and straight-fluted, with or without hydroxyapatite coating. Moreover adaptors are available to revise HMRS^® implants. This series includes 88 males and 73 females ranging in age from 9 to 80 years. Sites of reconstruction were 109 distal femurs, 19 proximal femurs, 1 total femur and 32 proximal tibias. There were 149 oncologic and 12 non oncologic diagnoses, including 96 primary reconstructions and 65 revisions after failure of previous implant. A retrospective analysis of imaging and complications was performed and functional results assessed according to MSTS system. Statistical analysis with Kaplan-Meier curves was used to study implant survival.

Results: At a mean follow up of 2 yrs. 106 patients are continuously NED, 31 are NED after treatment of one or more local recurrence or metastasis, 7 AWD, 5 DWD. There were 10 major complications: 8 infections (4,7%) (5 in primary and 3 in secondary implants, 2 previously infected) and 2 aseptic loosening (1,2%) (1 each). There were 9 minor complications (4 wound sloughs, 1 stiff joint, 3 disrupted extensor apparatus,1 patellar instability) requiring revision. Comparative statistical analysis of primary and secondary implants survival at major complications shows no statistically significant difference. Functional results were good or excellent in 95% of the evaluated patients, without any poor.

Conclusions: Middle term results are promising: good function, very low incidence of major complications, no breakage of implant components. This prosthetic reconstruction is indicated in oncological cases as well as in selected in some non oncological settings, such as challenging revisions of prosthetic failures with massive bone loss or post-radiation non unions or allografts failures. Although a higher incidence of complications was expected in secondary implants, statistical analysis shows similar survival.