Trial results for the Actis Total Hip System were posted on ClinicalTrials.gov on 2025-05-22, providing two-year follow-up data on its performance in total hip arthroplasty (THA) and hemi-hip arthroplasty (HHA) procedures. For THA subjects, the system achieved a mean Harris Hip Score of 95.7 at two years and a post-operative 2-year device survivorship of 97.7%.
Background
Osteoarthritis is a degenerative joint disease that commonly affects the hip, leading to pain, stiffness, and reduced mobility. When conservative treatments fail, total hip arthroplasty (THA) is a highly effective surgical intervention to relieve pain and restore function. The Actis Total Hip System is a commercially available option for cementless primary hip arthroplasty. Evaluating its long-term clinical and radiographic performance is crucial for understanding its efficacy and safety in patients with conditions like osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, and avascular necrosis of the femoral head.
Trial design
This completed study, which did not specify a traditional phase, enrolled a total of 266 participants. The trial aimed to evaluate the clinical outcomes of the commercially available Actis Total Hip System in cementless primary total hip arthroplasty (THA) and hemi-hip arthroplasty (HHA) procedures. The conditions investigated included Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congenital Hip Dysplasia, and Avascular Necrosis of the Femoral Head. Assessments included clinical, radiographic, and device and procedure-related adverse event evaluations over a two-year period.
Key results
Key measurements from the trial at various time points include:
- Harris Hip Score- THA Subjects Per Protocol at 2 Years: The mean Harris Hip Score was 95.7 (Standard Deviation 9.3) units on a scale for THA subjects.
- Harris Hip Score- HHA Subjects Per Protocol at 2 Years: The mean Harris Hip Score was 83.2 (Standard Deviation 15.3) units on a scale for HHA subjects.
- Harris Hip Score- THA Subjects Per Protocol at 3 Months: The mean Harris Hip Score was 93.5 (Standard Deviation 8.7) Units on a scale for THA subjects.
- Harris Hip Score- HHA Subjects Per Protocol at 3 Months: The mean Harris Hip Score was 85.3 (Standard Deviation 14.3) units on a scale for HHA subjects.
- Harris Hip Score- THA Subjects Per Protocol at 1 Year: The mean Harris Hip Score was 95.7 (Standard Deviation 9.0) Units on a scale for THA subjects.
- Harris Hip Score- HHA Subjects Per Protocol at 1 Year: The mean Harris Hip Score was 85.8 (Standard Deviation 12.6) units on a scale for HHA subjects.
- Post-Operative 2-Year Device Survivorship- THA Subjects Safety Population: The device survivorship was 97.7 Percentage of hip Implants.
- Post-Operative 2-Year Femoral Stem Survivorship- THA Subjects Safety Population: The femoral stem survivorship was 99.6 Percentage of hip Implants.
- Acetabular Shell Version at 2-years Postoperatively- THA Subjects Per Protocol: The mean version was 25.9 (Standard Deviation 3.89) Degrees.
- Acetabular Shell Inclination at 2-years Postoperatively- THA Subjects Per Protocol: The mean inclination was 39.9 (Standard Deviation 4.87) Degrees.
- Number of Participants With >4 Degrees Change in Acetabular Cup Inclination Angle at 2 Years Postoperatively - THA Subjects: 1 Participants experienced this change.
- Number of Participants With Acetabular Shell Migration >2mm at 2 Years Postoperatively - THA Subjects Per Protocol: 0 Participants experienced this migration.
What this means
The two-year follow-up results for the Actis Total Hip System indicate favorable clinical outcomes and high implant survivorship for patients undergoing total hip arthroplasty. The consistently high Harris Hip Scores, with a mean of 95.7 for THA subjects at both 1 and 2 years, suggest significant improvement in hip function and pain relief. The impressive 97.7% 2-year device survivorship and 99.6% femoral stem survivorship for THA subjects underscore the stability and durability of the implant. Furthermore, radiographic assessments showing minimal changes in acetabular shell inclination and no reported migration greater than 2mm suggest good implant fixation and stability. These findings support the Actis Total Hip System as an effective option for patients requiring primary hip arthroplasty due to conditions such as osteoarthritis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02783274, titled "Actis Total Hip System 2 Year Follow-up", were posted on 2025-05-22 on clinicaltrials.gov.