Actis Total Hip System 2 Year Follow-up

NCT02783274 | Completed Results FDA Device

• 1 other identifier: 14014
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Osteoarthritis; Traumatic Arthritis; Rheumatoid Arthritis; Congenital Hip Dysplasia; Avascular Necrosis of the Femoral Head; Acute Traumatic Fracture of the Femoral Head or Neck; Certain Cases of Ankylosis; Non-union of Femoral Neck Fractures; Certain High Sub-Capital & Femoral Neck Fractures in Elderly

Outcome Measures

Primary Outcomes (2)

• Harris Hip Score- THA Subjects Per Protocol at 2 Years

  The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent.

  2 Years

• Harris Hip Score- HHA Subjects Per Protocol at 2 Years

  The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent.

  2 Years

Secondary Outcomes (38)

• Harris Hip Score- THA Subjects Per Protocol at 3 Months

  3 months

• Harris Hip Score- HHA Subjects Per Protocol at 3 Months

  3 months

• Harris Hip Score- THA Subjects Per Protocol at 1 Year

  1 Year

• Harris Hip Score- HHA Subjects Per Protocol at 1 Year

  1 Year

• Post-Operative 2-Year Device Survivorship- THA Subjects Safety Population

  2 Years

Study Arms (1)

Actis Total Hip System

OTHER

The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement

Device: Actis Total Hip System

Interventions

Actis Total Hip System DEVICE

Total Hip Replacement and Hemi-hip Replacement

Also known as: Actis DuoFix Femoral Stem

Actis Total Hip System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total primary hip replacement is indicated in the following conditions:
• A severely painful and/or disable joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Certain cases of ankylosis.
• Hemi-hip arthroplasty is indicated in the following conditions:
• Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
• Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
• Avascular necrosis of the femoral head.
• Non-union of femoral neck fractures.
• Certain high sub-capital and femoral neck fractures in the elderly.
• Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
• Pathology involving only the femoral head in which the acetabulum does not require replacement.
• Individuals who are able to speak, read, and comprehend the informed patient consent (IPC) document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes (Joint Reconstruction).
• Individuals who are willing and able to return for follow-up as specified by the study protocol.

You may not qualify if:

• Active local or systemic infection.
• Loss of musculature, neuromuscular compromise or vascular
• 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).
• Charcot's or Paget's disease.
• 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.
• The Subject is a woman who is pregnant or lactating.
• Existing contralateral hip that was implanted less than 6 months from the date of surgery at the time of consent into this study.
• 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.
• Subject had a contralateral amputation.
• Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
• Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
• Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
• Subject has a medical condition with less than 2 years of life expectancy. Note: Diabetes, at present, has not been established as a contraindication. However, because of the increased risk for complications such as infection, slow wound healing, etc., the physician should carefully consider the advisability of hip replacement in the severely diabetic patient.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (9)

Unknown Facility

Louisville, Kentucky, 40241, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

Lebanon, New Hampshire, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Renton, Washington, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Hip Dislocation, Congenital; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kirstin Cosgrove
• Organization: Johnson & Johnson MedTech

kcosgro1@its.jnj.com

+1 574 4049398

Study Officials

• Deborah German, BS

  DePuy Synthes

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single cohort of Total Hips and the protocol also includes a single cohort for Hemi-hips. No comparisons are made to comparator devices, no randomization (open label). gathering data for a Post-market clinical follow-up study.

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 26, 2016
• Study Start: July 1, 2016
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: August 15, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (9)