Pre-Op THA Modelling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Replacing diseased hip joints with prosthetic implants in a procedure called total hip arthroplasty (THA) is associated with high rates of patient satisfaction, pain relief, and functional improvement when the implant is appropriately placed. Incorrect implant size or placement may lead to a breadth of negative outcomes, which could result in the need for implant revision. It is difficult to assess the precise orientation of patient hips on the operating table, with one study revealing that only 26% of acetabular cups placed without technological assistance are correctly positioned. Using computer navigation as a guide to achieve optimal implant alignment may improve successful placement rates. The additional incorporation of real-time modeling software may further help realize higher rates of successful implant placement. This study, therefore, aims to investigate a computer navigation system coupled with real-time modeling software to establish the benefit of such technology in the operating room, and further improve positive patient outcomes following THA. We hypothesize that including technological assistance in THAs will yield better patient outcomes compared to surgeries performed freehand.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of a Software to Predict the Postoperative Component Position in Total Hip Arthroplasty (THA)

NCT07107282

Total Hip Arthroplasty

NOT_YET_RECRUITING

THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips

NCT02682602

Hip Injuries

COMPLETED

Total Hip Arthroplasty (THA): Early Load Versus Load Late

NCT01495546

Primary Total Hip Arthroplasty

UNKNOWN NA

Modeling and Workflow Recognition for the Anterior Approach in Total Hip Arthroplasty

NCT05993845

Hip Prosthesis

RECRUITING

Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

NCT01668160

Osteoarthritis of Hip Failure of Primary THA

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Hip Arthroplasty Computer-Assisted Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prospective Computer-Navigated Cohort

Patients in this arm will receive standard patient of care implants but navigation software will be used to plan optimal acetabular cup placement.

Group Type EXPERIMENTAL

Computer-navigated THA surgery

Intervention Type PROCEDURE

Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.

Cross-sectional Standard of Care Cohort

Patients in this arm will receive standard of care implants and undergo standard of care procedure for total hip arthroplasty.

Group Type ACTIVE_COMPARATOR

Standard of care THA surgery

Intervention Type PROCEDURE

Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Computer-navigated THA surgery

Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.

Intervention Type PROCEDURE

Standard of care THA surgery

Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* osteoarthritis of the hip requiring primary THA
* 40 years of age or older
* BMI \<40 kg/m2
* able to provide informed consent, able and willing to do study assessments and follow instructions

Exclusion Criteria

* prior surgery on the indicated hip with insertion of hardware
* prior surgery on the lower spine with insertion of hardware
* hip and/or spinal fixed deformities or inflammatory/ossification processes of the spine (e.g. DISH, ankylosing spondylolisthesis)
* limitations to range of motion of the contralateral hip

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No