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Actis Total Hip System 2 Year Follow-up | Clinical Trials | Clareo Health

COMPLETEDNA

Actis Total Hip System 2 Year Follow-up

NCT02783274•DePuy Orthopaedics

Summary

Two-year (2 year) information regarding the performance of the commercially available Actis™ Total Hip System in order to obtain and evaluate the clinical outcomes on a series of cementless primary total hip arthroplasty (THA) and hemi-hip arthroplasty procedures using clinical, radiographic and device and procedure related adverse event assessments.

Detailed Description

A minimum of 10 study sites. A prospective, uncontrolled, non-randomized, multicenter study. A total of 255 Subjects to include a minimum of 225 Primary THA Subjects and a Sub-group with a minimum of 30 hemi-hip arthroplasty Subjects will be prospectively enrolled into the study. All Subjects will be seen for a preoperative clinic visit at the time of consent, and evaluated at the time of surgery, 6 weeks (28-70 days), 3 months (71-132 days), minimum 1 year (304-668 days), and minimum 2 years (669-1,763 days) postoperatively.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Total primary hip replacement is indicated in the following conditions:
•1. A severely painful and/or disable joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
•2. Avascular necrosis of the femoral head.
•3. Acute traumatic fracture of the femoral head or neck.
•4. Certain cases of ankylosis.
•Hemi-hip arthroplasty is indicated in the following conditions:
•5. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
•6. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
•7. Avascular necrosis of the femoral head.
•8. Non-union of femoral neck fractures.
+11 more criteria

Exclusion Criteria

•Subjects will be excluded if in the opinion of the Investigator, the individual meets any of the following exclusions:
•1. Active local or systemic infection.
•2. Loss of musculature, neuromuscular compromise or vascular
•3. Poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
•4. Charcot's or Paget's disease.
•5. For hemi-hip arthroplasty, any pathological condition of the acetabulum, such as distorted acetabuli with irregularities, protrusion acetabuli (arthrokatadysis), or migrating acetabuli, that would preclude the use of the natural acetabulum as an appropriate articular surface for the hemi-hip prosthesis.
•6. The Subject is a woman who is pregnant or lactating.
•7. Existing contralateral hip that was implanted less than 6 months from the date of surgery at the time of consent into this study.
•8. Subjects requiring a simultaneous bilateral hip at the time of consent will be excluded; there can be only one Actis™ study hip. This also means that even if another hip system is used for the contralateral hip during simultaneous THAs, the Subject will be excluded. As noted above, Subjects who have an existing contralateral total hip replacement greater than 6 months postoperatively at the time of consent may be entered into this study if they qualify based upon the eligibility criteria and the approved labeling requirements.
•9. Subject had a contralateral amputation.
+5 more criteria

Locations (9)

Louisville, Kentucky, United States

Boston, Massachusetts, United States

Rochester, Minnesota, United States

Lebanon, New Hampshire, United States

New York, New York, United States

Charlotte, North Carolina, United States

Philadelphia, Pennsylvania, United States

Austin, Texas, United States

Renton, Washington, United States

Key Dates

Start Date

July 1, 2016

Primary Completion Date

March 13, 2024

Completion Date

March 13, 2024

Last Updated

August 15, 2025

Enrollment

266

ACTUAL participants

Conditions

OsteoarthritisTraumatic ArthritisRheumatoid ArthritisCongenital Hip DysplasiaAvascular Necrosis of the Femoral HeadAcute Traumatic Fracture of the Femoral Head or NeckCertain Cases of AnkylosisNon-union of Femoral Neck FracturesCertain High Sub-Capital & Femoral Neck Fractures in Elderly

Interventions

Actis Total Hip System

DEVICE

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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RECRUITINGPHASE3

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

NCT07153471

Osteoarthritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Actis Total Hip System 2 Year Follow-up

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis

Plant-Based Diet for Patients With Rheumatoid Arthritis