RSA - ACTIS Hip Stem - Clinical Trial for Hip Osteoarthritis | NCT04879732

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

ACTIS

About this trial

This is an interventional other trial for Hip Osteoarthritis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty
Aged 21 years or older
Patients willing and able to comply with follow-up requirements and self-evaluations
Ability to give informed consent
Body mass index ≤45 kg/m2

Exclusion Criteria

Active or prior infection
Medical condition precluding major surgery
Medical condition with less than 2 years life expectancy
Overhanging pannus (for anterior approach cohort only)
Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
Skin condition on the area of incision
Multi-level lumbar spine fusion
Ankylosing spondylolithesis
Shortening osteotomy through the femur

Sites / Locations

Orthopaedic Innovation Centre
Nova Scotia Health - Orthopedic
London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ACTIS hip stem

Arm Description

All participants will receive the ACTIS hip stem.

Outcomes

Primary Outcome Measures

Subsidence of the ACTIS femoral stem

Compare mean 2-year subsidence using model-based RSA (radiostereometric analysis) (mm). The images taken at each time point will be compared with the baseline to assess the change in implant position.

Secondary Outcome Measures

Comparison of migration per surgical approach

Comparison between the 3 approaches (postero-lateral, direct lateral, and direct anterior); measured migration (mm). The images taken at each time point will be compared with the baseline to assess implant migration. Therefore the outcome is change in implant position measured using RSA.

Oxford Hip Score (OHS)

Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance.

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Evaluate and compare the change from preoperative to 2 years between the study groups and timepoints. The scores in each section (pain, stiffness and function limitation) are totaled; 5 items for pain (score range 0-20), 2 for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

European Quality of Life (EQ-5D-5L) questionnaire

Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome. A health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state. The overall health state range from 0 to 1.0.

Visual analogue scale (VAS) for thigh pain

Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable).

Visual analogue scale (VAS) for satisfaction

Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied).

University of California at Los Angeles (UCLA) Activity Level scale

Evaluate and compare the change in UCLA activity score compared to baseline in the study cohort. UCLA activity scores range from 1 to 10, and is a measure of activity with 10 being most active.

Full Information

NCT ID

NCT04879732

First Posted

April 30, 2021

Last Updated

June 26, 2023

Sponsor

Canadian Radiostereometric Analysis Network

Collaborators

DePuy Synthes

1. Study Identification

Unique Protocol Identification Number

NCT04879732

Brief Title

RSA - ACTIS Hip Stem

Official Title

Roentgen Stereophotogrammetric Analysis (RSA): ACTIS Hip Stem

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 5, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Canadian Radiostereometric Analysis Network

Collaborators

DePuy Synthes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

No

5. Study Description

Brief Summary

The principal objective of this study is to compare mean 2-year subsidence of the ACTIS femoral stem using model-based RSA against published migration patterns for hip stems of a similar design. Secondary objectives include comparison of migration per surgical approach, quantifying changes in functional and health status of subjects following surgery, and assess occurrences of complications and adverse events.

Detailed Description

This is a multi-centre, sequential enrollment trial of patients undergoing primary total hip arthroplasty. Patients will be recruited at three Canadian Centres to receive the ACTIS femoral hip stem via 3 different surgical approaches. Model-based RSA will identify migration of the implant with respect to the femoral bone during the first 2 post-operative years. Patient health and functional outcomes will be recorded at pre- and post-operative intervals to quantify improvement as a result of the surgery and trajectory of recovery. Adverse events and clinical complications in each study group will be captured and compared. Select surgical, hospital and rehabilitation data will be collected to measure health economic outcomes relating to the surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Osteoarthritis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACTIS hip stem

Arm Type

Other

Arm Description

All participants will receive the ACTIS hip stem.

Intervention Type

Device

Intervention Name(s)

ACTIS

Intervention Description

ACTIS Hip stem

Primary Outcome Measure Information:

Title

Subsidence of the ACTIS femoral stem

Description

Compare mean 2-year subsidence using model-based RSA (radiostereometric analysis) (mm). The images taken at each time point will be compared with the baseline to assess the change in implant position.

Time Frame

2 Year

Secondary Outcome Measure Information:

Title

Comparison of migration per surgical approach

Description

Comparison between the 3 approaches (postero-lateral, direct lateral, and direct anterior); measured migration (mm). The images taken at each time point will be compared with the baseline to assess implant migration. Therefore the outcome is change in implant position measured using RSA.

Time Frame

2 Year

Title

Oxford Hip Score (OHS)

Description

Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance.

Time Frame