NCT04191993

Direct Superior Approach (DSA) vs Posterior Approach (PA) in THA

A Prospective Randomised Controlled Trial Comparing the Direct Superior Approach Versus the Posterior Approach for Total Hip Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Total Hip Arthroplasty (THA) is a highly effective treatment for patients with symptomatic hip osteoarthritis. The surgical approach in THA is important as it influences postoperative clinical recovery, functional outcomes, and implant positioning \[1\]. The evolution of surgical techniques in THA has led to the development of minimally invasive surgery, which is performed through smaller skin incisions, reduced soft tissue disruption and greater muscle preservation \[2-10\]. This prospective, randomised control study compares clinical and radiological outcomes in THA performed using the standard posterior approach (PA) and its less invasive modification, the direct superior approach (DSA). The study will include 80 patients with hip osteoarthritis undergoing THA. Following informed consent, patients will be randomised to one of the two treatment groups, and undergo THA using either the PA or DSA. The control group includes patients undergoing THA through the PA while the investigation group includes patients undergoing THA with the DSA. A further 25 patients randomly selected from each treatment group will undergo radiosteriometric analysis (RSA) to assess differences in early implant migration between PA and DSA groups. Clinical and radiological outcomes of interest will be recorded by blinded observers at regular intervals for 2 years after surgery. The findings of this study will enable an improved understanding of differences in postoperative clinical recovery, functional outcomes, and implant positioning in THA performed using the DSA compared to the PA approach.

Conditions

• Surgery
• Surgical Incision
• Patient Satisfaction

Interventions

Type	Name	Description
DEVICE	Total hip arthroplasty	Surgical intervention designed to replace arthritic joint with artificial implant

Timeline

• Start date: 2018-06-12
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2019-12-10
• Last updated: 2023-06-28

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study