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Short-term clinical and radiographic outcomes of a novel, minimally invasive device for treatment of CMC arthritis
Lorenzo L Pacelli, MD
1; Roslyn M Kackman, BA
21Orthopaedic Surgery, Scripps Clinic, La Jolla, CA; 2Shiley Center for Orthopaedic Research and Education, La Jolla, CA
introductionThe Ensemble CMC™ is an interpositional pyrocarbon device with a saddle-shaped design that approximates the natural anatomy of the articular surfaces of the carpometacarpal (CMC) joint and indicated for early to moderate stage basal thumb arthritis (Figure 1). The purpose of this study was to assess the clinical and radiographic outcomes among patients who received the Ensemble CMC™.
materials & MethodsThe first 26 patients who received the Ensemble CMC™ by a single surgeon with a minimum follow up of 6 months were included. The CMC joint was exposed through a volar Wager approach that allowed visualization of entire trapezium. Osteophytes were removed and the metacarpal and trapezium were prepared using a series of rasps that shaped the bone to the specifications of the device. Trials were used to determine the optimal size implant on the trapezium, appropriate ligamentous tensioned, and normal range of motion of the joint. Clinical outcomes included the Visual Analog Scale (VAS) pain scores, Disabilities of the Arm, Shoulder, and Hand (QuickDASH), pinch strength (lateral and 3-point), and grip strength. Clinical outcomes were assessed at 3 months, 6 months, 1 year, and 2 years. The average follow-up time was 14.3 months. Radiographs were used to assess the level of CMC osteoarthritis prior to surgery and postoperative implant position and subsidence.
ResultsThe median age was 64.3 years and 57.7% were female. The median VAS pain score was 7 preoperatively and decreased at 3 months (p=0.009), 6 months (p<0.001), and 1 year postoperatively (p=0.005), with a slight increase at 2 years (Table 1). The median QuickDASH score was 46.2 preoperatively, with a statistically significant decrease at 6 months (p<0.001) and 1 year (p=0.005). Compared to preoperative measurements, grip strength, 3-pt pinch strength, and lateral pinch strength decreased at 3 months postoperatively, but returned to preoperative levels by 6 months. Preoperative radiographs confirmed Eaton 2-3 classification. Postoperative radiographic review at 3, 6 months, 1 and 2 years confirmed no dislocation implant. One patient required revision surgery for continued pain at 1 year postop, successfully converted to LRTI arthroplasty.
ConclusionsThe Ensemble CMC™ provided a viable surgical option for the treatment of early to moderate stage basal thumb arthritis among a case series of patients. Patients' pain and function scores improved at follow-up, pinch and grip strength remained stable with no dislocations and one failure requiring revision to LRTI arthroplasty at 1 year follow-up.
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