Hip OsteoarthritisNCT04541693
REDAPT Revision Hip System With RSA
A study testing Full revision, Cup revision and Stem revision in people with Hip Osteoarthritis, run by Orthopaedic Innovation Centre at 1 site in Canada.
Trial summary
The principal objectives of the study are to evaluate early and mid-term fixation of the REDAPT revision hip stem and acetabular cup as measured by stem subsidence and proximal cup migration at 2 and 5 years post-surgery through model-based RSA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Full revision, Cup revision and Stem revision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients needing revision hip arthroplasty in which either the femoral stem or the acetabular cup, or both components, will be revised
- Ability to use study device (not requiring specialized implants)
- Patients between the ages of 18+ older
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Who cannot join
- Acute infection requiring washout, debridement, and liner exchange
- Unresolved infection
- Undergoing stage 1 of a 2-stage revision for infection
- Known metal allergy to device components
- Active participation in another clinical study (within the past 30 days)
- Known risk for loss to follow-up (significant geographical distance from treatment centre)
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- BMI>40 (severe obesity)
- Unable to provide informed consent (cognitive impairment)
- Patients requiring a bearing couple different than metal on polyethylene
- Patients requiring extreme distal press-fit revision stems (greater than 240 mm in length)
- Patients with severe defects, dysplasia, or tumor
- Inflammatory joint disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Stability Assessment of the REDAPT Revision Hip System With Radiostereometric Analysis
The principal objectives of the study are to evaluate early and mid-term fixation of the REDAPT revision hip stem and acetabular cup as measured by stem subsidence and proximal cup migration at 2 and 5 years post-surgery through model-based RSA. Secondary objectives include; evaluate the progression of migration between 1 and 2 years and between 2 and 5 years, assess pre- to post-surgery patient improvement in function and health status, evaluate femoral and acetabular radiolucency at 2 and 5 years, and assess patterns of stem migrate on for different revision scenarios (preservation of the trochanters and extended trochanteric osteotomy).
Read the detailed description
This is a prospective, single arm, consecutive series study of patients undergoing revision hip arthroplasty. Patients will be grouped based on the revision implants they receive during surgery. Patients who receive a full hip revision (stem and cup), will be counted in both study groups. The two study groups are:
- femoral stem revision (n=30 hips)
- acetabular cup revision (n=22 hips)
- Conditions
- Hip Osteoarthritis
- Being tested
- Full revision, Cup revision, Stem revision
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full revisionDevice
Both cup and stem require revision
Cup revisionDevice
Only the cup requires revision
Stem revisionDevice
Only the stem requires revision
| Study group | Role | What they receive |
|---|---|---|
| Hip revision | Other | Revision to cup and stem, cup only or stem only. Receives: Device: Full revision; Device: Cup revision; Device: Stem revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year
Stability over a period of two year measured by migration with Röntgen Stereometric Analysis
Measured: Post-op: 2-week, 6-month, 1-year, 2-year
Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living.
Measured: Pre-op, Post-op (6 months, 1 year, and 2 years)
Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year
The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Measured: Pre-op, Post-op (6 months, 1 year, and 2 years)
Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year
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: Pre-op, Post-op (6 months, 1 year, and 2 years)
Changes in Patient Satisfaction (Likert scale) from baseline(pre-op) to 6-month, 1-year and 2-year
Patient satisfaction with their hip surgery will be assessed using a 5-point Likert scale: Very Unsatisfied (1), Unsatisfied (2), Neutral (3), Satisfied (4), and Very Satisfied (5).
Measured: Pre-op, Post-op (6 months, 1 year, and 2 years)
Secondary outcomes (1)
Stem subsidence
Comparing RSA exams at the specified time points to determine relative movement of the REDAPT hip stem
Measured: 1-year, 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start15 Jan 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Innovation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Turgeon, MD, Principal investigator, Concordia Joint Replacement Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541693
- Sponsor's protocol ID
- B2018-092
- Status last verified
- Nov 2024
- First submitted
- 31 Aug 2020
- Last updated
- 15 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Stability Assessment of the REDAPT Revision Hip System With Radiostereometric Analysis
- ClinicalTrials.gov ID
- NCT04541693
- Acronym / sponsor ID
- B2018-092
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Orthopaedic Innovation CentreUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Sep 2020 (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 objectives of the study are to evaluate early and mid-term fixation of the REDAPT revision hip stem and acetabular cup as measured by stem subsidence and proximal cup migration at 2 and 5 years post-surgery through model-based RSA. Secondary objectives include; evaluate the progression of migration between 1 and 2 years and between 2 and 5 years, assess pre- to post-surgery patient improvement in function and health status, evaluate femoral and acetabular radiolucency at 2 and 5 years, and assess patterns of stem migrate on for different revision scenarios (preservation of the trochanters and extended trochanteric osteotomy).
Detailed description
This is a prospective, single arm, consecutive series study of patients undergoing revision hip arthroplasty. Patients will be grouped based on the revision implants they receive during surgery. Patients who receive a full hip revision (stem and cup), will be counted in both study groups. The two study groups are:
- femoral stem revision (n=30 hips)
- acetabular cup revision (n=22 hips)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip revision | Other | Device: Full revision, Device: Cup revision, Device: Stem revisionRevision to cup and stem, cup only or stem only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients needing revision hip arthroplasty in which either the femoral stem or the acetabular cup, or both components, will be revised
- Ability to use study device (not requiring specialized implants)
- Patients between the ages of 18+ older
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Key exclusion criteria (12 listed)
- Acute infection requiring washout, debridement, and liner exchange
- Unresolved infection
- Undergoing stage 1 of a 2-stage revision for infection
- Known metal allergy to device components
- Active participation in another clinical study (within the past 30 days)
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 |
|---|---|---|
| Full revisionBoth cup and stem require revision | Device | Hip revision |
| Cup revisionOnly the cup requires revision | Device | Hip revision |
| Stem revisionOnly the stem requires revision | Device | Hip revision |
Primary outcome
Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year
Time frame: Post-op: 2-week, 6-month, 1-year, 2-year
Stability over a period of two year measured by migration with Röntgen Stereometric Analysis
Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
Time frame: Pre-op, Post-op (6 months, 1 year, and 2 years)
The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living.
Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year
Time frame: Pre-op, Post-op (6 months, 1 year, and 2 years)
The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year
Time frame: Pre-op, Post-op (6 months, 1 year, and 2 years)
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)
Changes in Patient Satisfaction (Likert scale) from baseline(pre-op) to 6-month, 1-year and 2-year
Time frame: Pre-op, Post-op (6 months, 1 year, and 2 years)
Patient satisfaction with their hip surgery will be assessed using a 5-point Likert scale: Very Unsatisfied (1), Unsatisfied (2), Neutral (3), Satisfied (4), and Very Satisfied (5).
1 secondary outcome
Stem subsidence
Time frame: 1-year, 2-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
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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
Concordia Joint Replacement Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full revision, Cup revision and Stem revision in people with Hip Osteoarthritis, run by Orthopaedic Innovation Centre at 1 site 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 12 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: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year (time frame: Post-op: 2-week, 6-month, 1-year, 2-year). The study lists 5 primary outcomes in all. 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 15 Nov 2024.