NCT04989998

Patient Outcomes Using HIP7 Software as Compared to Conventional THA

A Prospective, Multi-center, Randomized Controlled Study to Evaluate Patient Outcomes Using Hip7 Software as Compared to Conventional Surgical Technique in S+N Total Hip Arthroplasties (THA)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to demonstrate how Hip7 software can lead to improved patient outcomes compared to conventional procedures with standard instrumentation for total hip arthroplasties (THA) surgery.

Detailed description

This study is a prospective, multi-center, randomized, controlled clinical study in total hip arthroplasties (THA) surgery. The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive THA using either Hip7 software or conventional instrumentation. The clinical follow-up evaluation will be performed preoperatively (Baseline), operatively, 6 weeks, 6 and 12 months after surgery using patient reported outcome measures regarding their general health, hip and physical abilities, quality of life and pain level.

Conditions

• Hip Replacement

Interventions

Type	Name	Description
DEVICE	Hip7 Software on Kick/ CORI platforms	Total hip arthroplasty surgery using Hip7 software on Kick or CORI platforms using R3 Polarstem implants.
DEVICE	Conventional surgical procedures	THA surgery using standard, manual instrumentation and digital templating techniques using R3 polarstem implants.

Timeline

• Start date: 2021-09-30
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2021-08-04
• Last updated: 2022-07-29

Regulatory

• FDA-regulated device study