Abstract
Background: Poor results were observed at medium term follow-up (FU) after first and second generation cementless stems implantation in total hip arthroplasty (THA). Revision rate up to 24% is reported with anatomic stems; stress-shielding rate up to 50%, thigh pain rate up to 21%, loosening rate up to 20% and osteolysis rate up to 29% were reported with cylindrical stems. A third generation tapered stem, the Synergy stem, was introduced in 1996 to rise such weakness points.
Material and methods: A retrospective, cohort study was carried out in two academic centers (London, Toronto, Canada & Rome, Italy) on 232 primary THA in 215 patients with a 10 to 12 yrs FU. Mean age at surgery was 60 yrs (18–82), 95 patients were males and 120 females. Thirty-six patients were lost at FU (13 died before the 10 yrs mark, 22 changed residency, 1 not willing to be seen) with no problems related to the replaced hip. Remained at FU 196 THA. Patients selection: Dorr type A and B femurs suitable for receive a Synergy stem. Its characteristics are the following: Ti-6Al-4V, straight, tapered, 3D wedge cross-section, proximal antirotational fins, low-profile neck, neck angle 131°, metaphyseal part porous or HA coated, diaphyseal part grit blasted, polished tip, surgeon-friendly ancillary instruments. Clinical results of the 196 THA with more than 10 yrs of FU were assessed preoperatively and postoperatively at 5 and 10 or 11 or 12 yrs by means of standard evaluation tools: SF12, WOMAC and Harris Hip Score. Thigh pain frequency and intensity were also scored. Radiographic analysis was focused on stem alignment, bone ingrowth, radiolucent lines presence, width and progression, stress-shielding, heterotophic ossification (HTO). Student paired test and Kaplan-Meier survival analysis were used for statistical analysis.
Results: All clinical evaluation tools showed both at 5 years FU and at latest FU (10–12 years) a statistically significant (p=0,001) improvement compared to the preoperative scores. We observed a not constant thigh pain in 7 patients (5,5%). Nineteen patients (10%) underwent evision due to polyethylene wear (6 cases), late periprosthetic fracture (5 cases), subsidence (2 cases), instability (3 cases), infection (3 cases). Cumulative survival rate was 97% at 2 and 5 years, 90% at 10 years. Stem related revisions were the 2 cases of subsidence, both related to occult intraoperative calcar crack and early revised (within 1 year); cumulative stem-related survival rate at 10 years was 99%. Alignment was varus in 9 cases and valgus in 3. Bone in-growth was observed in 194 patients (98%). Radiolucent lines were uncommon, non progressive, less than 2 mm, in Gruen zones 2 and 6. Stress-shielding was present as cortical reaction in 5 femurs in Gruen zones 3 and 5. Thirty-four cases of HTO (grade I and II in 27 case and grade III in 7 cases) were observed.
Conclusions: The Synergy stem demonstrates excellent clinical and radiographic results at 10–12 yerars FU in 196 patients. Survivorship (with stem revision as end point) is 99% at 10 years. Thigh pain is uncommon and the level of activity and autonomy is excellent. Radiographically bone ingrowth is evident in all stems and radiolucent lines are “benign” with no aseptic loosening. Attention must be paid at the moment of stem press fit insertion to avoid occult proximal femoral fractures that may require revision surgery.
Correspondence should be addressed to Diane Przepiorski at ISTA, PO Box 6564, Auburn, CA 95604, USA. Phone: +1 916-454-9884; Fax: +1 916-454-9882; E-mail: ista@pacbell.net