EVALUATION OF A NEW UNCEMENTED, FULLY HYDROXYAPATITE-COATED FEMORAL STEM FOR TREATMENT OF FEMORAL NECK FRACTURES. EARLY RESULTS

Abstract

Background: The standard fixation of femoral stems used for patients with femoral neck fractures is bone cement. Bone cement has side effects related to co-morbidity. The purpose of this study is to evaluate fixation, bone remodelling and clinical results with a new uncemented, fully hydroxyapatite-coated tapered femoral stem (Fracture Stem^®) designed for press-fit insertion in patients with femoral neck fractures.

Methods: Forty patients (25 women, 15 men) at a mean 82 (70–92) years of age with an acute displaced femoral neck fracture were included in the study. The patients were operated with the new stem and received a total hip arthroplasty. Tantalum markers were placed in the proximal femur during surgery. We have so far followed the patients for 1 year postoperatively with radiostereometric measurements, dual-energy x-ray absorptiometry and clinical evaluation including Harris hip score, pain numerical rating scale and health related quality of life.

Results: The stem showed good fixation. Subsidence and stem rotation for all stems but five were close to zero. Maximum total point motion increased above precision error at the 6 weeks follow-up but did not increase significantly after that. All stems with significant migration were stable after 3 months. We have had no per–or postoperative fracture. One stem has had to be revised because of a deep infection. Median bone loss after 6 months was significant (p=0.018 to 0.028) in all zones but Gruen zone 4. Bone loss was greatest in Gruen zone 1, 2, 6 and 7 with 29%, 22%, 18% and 32% loss respectively. Median Harris hip score decreased significantly (p=0.003) from 89 before fracture to 75 and 78 at the 6 weeks and 6 months follow-up. Pain numerical rating scale and Health related quality of life decreased until the 6 week visit but returned to prefracture value at 6 months.

Conclusions: According to these early 1-year results, Fracture Stem^® shows good fixation and fast ingrowth in osteoporotic bone. Periprosthetic bone loss due to stress-shielding was significant in all zones but zone 4. Clinically the stem behaved as expected. According to our results, we propose a randomized cinical trial in a larger patient population as the next step to evaluate this femoral stem.