Hip OsteoarthritisNCT04879732
RSA - ACTIS Hip Stem
A study testing ACTIS in people with Hip Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- ACTIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesCanada
- Study dates
- 5 Oct 2021to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Multi-level lumbar spine fusion
- Ankylosing spondylolithesis
- Shortening osteotomy through the femur
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Nova Scotia Health - Orthopedic
Halifax, Nova Scotia, B3H 2E1
London Health Sciences Centre
London, Ontario, N6A 5W9
Orthopaedic Innovation Centre
Winnipeg, Manitoba, R2K 2M9
About this study
Official title: Roentgen Stereophotogrammetric Analysis (RSA): ACTIS Hip Stem
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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- ACTIS
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTISDevice
ACTIS Hip stem
| Study group | Role | What they receive |
|---|---|---|
| ACTIS hip stem | Other | All participants will receive the ACTIS hip stem. Receives: Device: ACTIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Year
Secondary outcomes (7)
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.
Measured: 2 Year
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.
Measured: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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.
Measured: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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.
Measured: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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).
Measured: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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).
Measured: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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.
Measured: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start5 Oct 2021
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Radiostereometric Analysis Network
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Sponsor
- Investigators
- Thomas Turgeon, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879732
- Sponsor's protocol ID
- B2021:005
- Status last verified
- Dec 2025
- First submitted
- 30 Apr 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roentgen Stereophotogrammetric Analysis (RSA): ACTIS Hip Stem
- ClinicalTrials.gov ID
- NCT04879732
- Acronym / sponsor ID
- B2021:005
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Canadian Radiostereometric Analysis NetworkUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTIS hip stem | Other | Device: ACTISAll participants will receive the ACTIS hip stem. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTISACTIS Hip stem | Device | ACTIS hip stem |
Primary outcome
Subsidence of the ACTIS femoral stem
Time frame: 2 Year
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.
7 secondary outcomes
Comparison of migration per surgical approach
Time frame: 2 Year
Oxford Hip Score (OHS)
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
European Quality of Life (EQ-5D-5L) questionnaire
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Visual analogue scale (VAS) for thigh pain
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Visual analogue scale (VAS) for satisfaction
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
University of California at Los Angeles (UCLA) Activity Level scale
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Turgeon, MD principal investigator
University of Manitoba
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIS in people with Hip Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subsidence of the ACTIS femoral stem (time frame: 2 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.