Patient outcomes using HIP7 software as compared to conventional THA
Research type
Research Study
Full title
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)
IRAS ID
297386
Contact name
Edward Davis
Contact email
Sponsor organisation
Smith+Nephew
Duration of Study in the UK
2 years, 9 months, 30 days
Research summary
Background: HIP7 is a system of software and hardware as well as surgical instruments. The system assists the implantation of prosthetic hip implants by helping the surgeon place the acetabular hip implant (cup) accurately according to the patients pelvic anatomy. Further, the HIP7 navigation system accurately measures the total leg length and offset change of the treated leg in respect to the pelvic bone.
Purpose: This study is being carried out to demonstrate how Hip7 software can lead to improved patient outcomes compared to conventional procedures with standard instrumentation and digital templating techniques.
Objectives:
The primary objective of this study is to compare Forgotten Joint Score (FJS) utilizing Hip7 software on KICK and CORI platforms with POLAR3 system to conventional procedures with standard instrumentation and digital templating techniques at 12 months post-operation.
Secondary objectives are to generate performance data on the Hip7 software regarding cup placement accuracy, range of motion, functional scores and dislocation rates.Research participants/locations: A total of 440 subjects will be enrolled in 4-8 sites in China, North America and UK. 220 subjects will be enrolled for Hip7 Software on Kick or CORI platforms using POLAR3 system and 220 subjects will be enrolled for conventional procedures with standard, manual instrumentation and digital templating techniques utilizing POLAR3 system.
REC name
HSC REC B
REC reference
21/NI/0117
Date of REC Opinion
16 Jul 2021
REC opinion
Unfavourable Opinion