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NCT05416463 Clinical Trial

Clinical Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

— INSTHA  

Official title:
A Single-blinded Randomized Control Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05416463
Other study ID # INSTHA
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2022
Est. completion date December 2024

Study information
Verified date June 2022
Source Grand River Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the clinical and health economic value of an intraoperative navigation system for total hip arthroplasty in one Ontario hospital. The results of this study will be used to generate evidence-based recommendations on the use and funding of the device in public hospitals and inform the development of a provincial healthcare innovation pathway.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 190
Est. completion date December 2024
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Receiving primary THA - Elective THA - Provision of informed consent Exclusion Criteria: - Unable to obtain informed consent - Receiving revision THA - THA is to treat trauma (i.e. hip fracture and/or dislocation) - Patient is undergoing simultaneous bilateral hip replacement - Performing surgeon is not participating in the study - Hip fracture - Hip dislocation - Severe osteoporosis - Trochanteric osteotomy - Suspected or actual infection - Existing implanted hardware - Severe deformities of the femoral or pelvic bone - High Body Mass Index (BMI)*

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Intra-Operative Device for THA
The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Grand River Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Activities of Daily Living Hip disability and Osteoarthritis Outcome Score (HOOS)
Scores are 1-100 and each subscale is scored and then connected with a line on a graph to generate a "HOOS profile".
"0 indicates extreme problems and 100 indicates no problems."		 up to 12 months
See also
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Completed NCT02242201 - Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular Phase 4
Completed NCT02414542 - Minima Clinical Study
Completed NCT01817010 - Strength and Function Following Total Hip Arthroplasty N/A
Completed NCT01443975 - Clinical Evaluation on the Use of the X-pander Device N/A
Recruiting NCT05530174 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture N/A
Recruiting NCT05530551 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA N/A
Recruiting NCT05054192 - Reliability and Validity of Modified Four Square Step Test
Recruiting NCT06141928 - Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty N/A
Recruiting NCT04492462 - The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery N/A
Withdrawn NCT02926651 - Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty Phase 4
Completed NCT02308813 - Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip N/A
Recruiting NCT02032017 - Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation. N/A
Recruiting NCT01312077 - The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement Phase 4
Withdrawn NCT01380665 - Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty Phase 4
Recruiting NCT05893563 - Corail Stability at 5-Years Post-Total Hip Arthroplasty
Recruiting NCT06088069 - Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty N/A
Active, not recruiting NCT03210844 - The Clinical Outcomes After Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty N/A
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