Abstract
Purpose: There are two broad-based categories of cementless femoral components performed during total hip arthroplasty: proximally coated versus fully porous coated. While both have enjoyed widespread clinical applications, there remains debate regarding differences in clinical outcome scores, relative incidence of thigh pain and the development of stress shielding. The purpose of this study was to investigate these variables in a multi-center prospective randomized blinded clinical trial.
Method: Between three centers 388 patients were enrolled in this clinical trial. 198 patients received a proximally coated tapered cementless femoral component (Synergy, Smith and Nephew, Memphis) and 190 patients received a fully porous coated cementless femoral component (Prodigy, Depuy, Warsaw). Patients were evaluated pre-operatively, at 3, 6, 12 months and annually thereafter, with multiple validated outcome measures including WOMAC, SF12, HSS, UCLA activity and thigh pain scores. A cohort of 72 patients underwent preoperative and postoperative DEXA scanning.
Results: 367 patients had a minimum of 2 years follow-up (average 6.4 years). There were no differences in age at surgery, BMI, or pre-operative clinical outcome scores (WOMAC, SF12, HSS, UCLA activity, thigh pain) between groups. There were no differences in any post-operative clinical outcome scores at any interval of follow-up. There were no differences in incidence of thigh pain between groups at any time. The only measurable difference between study groups was in bone mineral density evaluation. Bone density change in Gruen zone 7 was 23.7% with the Prodigy stem and 15.3% with the Synergy stem (p=0.011).
Conclusion: Both fully porous coated and proximally porous coated cementless stems performed well, with no clinical differences at a minimum of 2 years follow-up. Only bone mineral density evaluations could detect any differences between these femoral components designs.
Correspondence should be addressed to CEO Doug C. Thomson. Email: doug@canorth.org
