Abstract
Introduction
The BIRMINGHAM HIP◊ Resurfacing is a metal-on-metal (MOM) hip implant system approved by the US FDA in 2006. The approval required a multicenter, prospective, post-approval study (PAS). Our purpose is to report the current minimum 10-year results.
Methods
253 patients (280 hips) had surgery between October 2006 and December 2009 at one of 5 sites. We report revisions, survivorship, EQ-5D, Harris Hip Score (HHS), radiographic findings, and metal levels including cobalt (Co) and chromium (Cr). The mean age at surgery was 51 years, 74% male, BMI 28, osteoarthritis 95%. 243 (87%) of hips have known outcome or 10-year minimum follow-up (fup). Prior to 10 years, 5 patients died, 20 hips were revised, and 37 hips did not complete 10-year fup.
Results
The 10-year component survivorship is 92.9% (95% CI 89.8–96.1%). The reasons for revision were femoral neck fracture (3), femoral loosening (5), acetabular loosening (1), pseudotumor (3), osteolysis (2) and the remaining 6 for a combination of pain, noise, or metal levels.
The EQ-QAL VAS improved (mean preop: 70, 1-year: 89, p<0.001) and was stable through 10 years (87, p=0.05). The HHS improved (mean preop: 57, 1-year: 96, p<0.001) and remained stable through 10 years (96, p=0.93).
Radiographically, no surviving components have migrated. 4.6% (10/218) have osteolysis.
The Co and Cr levels increased at 1 year (median Co preop: 0.12 ppb, 1-year: 1.5 ppb, p<0.001; Cr preop: 0.60 ppb, 1-year: 1.70 ppb, p<0.001) and remained stable through 10 years (Co 10-year: 1.29 ppb, p=0.28; Cr 10-year: 1.36 ppb, p=0.88). The number of patients with a Co or Cr >7 ppb at one and 10 years remained similar (1-year: 3.4% (7/205), 10-year: 4.4%, (9/205), p=0.61).
Conclusion
This prospective, multicenter PAS demonstrated this resurfacing is safe and durable. 10-year survivorship for males less than 55 years old is 98.3% (95% CI 95.9–100%).
