Arthroplasties, Hip ReplacementNCT02661620
REDAPT Retrospective-Prospective Modular Stem Study
An observational study of Arthroplasties, Hip Replacement, run by Smith & Nephew, Inc. at 5 sites in 3 countries.
Trial summary
A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market performance and safety of the study device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasties, Hip Replacement
- What is being tested?
- REDAPT Revision Femoral System modular stem
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Feb 2016to 16 Apr 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subject has undergone revision hip arthroplasty with the REDAPT™ Revision Femoral System modular stem with implantation from 2012 to the date of Institutional Review Board (IRB)/Ethics Committee (EC) approval of this protocol at the study site.
Who may be able to join
- Retrospective Limited Data Collection/Enrollment Phase:
- Subject has undergone revision hip arthroplasty with the REDAPT™ Revision Femoral System modular stem with implantation from 2012 to the date of Institutional Review Board (IRB)/Ethics Committee (EC) approval ofthe original version 1.0 protocol at the study site.
- Retrospective Expanded Data Collection \& Prospective Follow-Up Phase:
- Subject completed limited retrospective data collection phase and willing to consent to expanded retrospective data collection and the prospective phase of the study;
- Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.
- Exclusion Criteria:Retrospective Limited Data Collection/Enrollment Phase:
Show all 10Show fewer
- Not applicable
- Retrospective Expanded Data Collection \& Prospective Follow-Up Phase:
- Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse; or
- Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Detroit Receiving Hospital
Detroit, Michigan, 48201
Baptist Health Louisville Orthopedic
Louisville, Kentucky, 40207
The Oregon Health & Science University
Portland, Oregon, 97239-3098
Canada1 site
CHU De Quebec- Hôpital Saint-François d'Assise
Québec, Quebec, G1L 3L5
About this study
Official title: A Retrospective-Prospective Study of REDAPT™ Revision Femoral System Modular Stem
A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market performance and safety of the study device. The study will collect retrospective data from medical records review and prospective data from observations data at 5 and 10 postoperatively clinical visits. There will also be a 7.5 year telephone follow up contact to assess for device status and adverse events.
Read the detailed description
The primary purpose of this study is to demonstrate the REDAPT™ Revision Femoral System modular stem cumulative revision rate at 5 years.
The secondary purpose of this study is to provide 10 years of safety and performance data on the REDAPT™ Revision Femoral System modular stem in terms of Standard of Care Radiographic Assessment, Harris Hip Sore (if obtained prior to implant), adverse event assessment, whole blood metal ion level assessment for Cobalt and Chromium (only performed if subject if symptomatic with pain, swelling, and/or functional limitation related to the device and/ implant procedure as assessed by the Principal Investigator (PI), and Metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) or Computed Tomography (CT) will be obtained if metal ion levels of Cobalt and/or Chromium > 7parts per billion (ppb) 140 subjects have been enrolled in the study at 5 clinical study sites around the world. A Clinical Study Report (CSR) will be completed at years 5 and 10.
- Conditions
- Arthroplasties, Hip Replacement
- Being tested
- REDAPT Revision Femoral System modular stem
- Keywords
- REDAPT Femoral System modular stem implant, Total Hip arthroplasty revision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REDAPT Revision Femoral System modular stemDevice
Medical record review for retrospective information and observational prospective data collection of standard of care items at 5 years and 10 years post operatively plus a 7.5 year post op telephone call to assess stem status and adverse events.
What is being measured
The primary outcome is the main question the study is designed to answer.
Modular stem revision
Listing of stem implant status at 5 years to analyze stem survival rate
Measured: 5 years post operatively
Secondary outcomes (4)
Revision of any component for any reason
revision for any reason
Measured: 5 year post operative
Radiographic assessments
radiographic measurements to assess linear radiolucencies and subsidence to assess safety and potential changeover time
Measured: follow-up to 10 years as per standard of care
Harris Hip Score
Clinical evaluation to score and assess changes over time from baseline through 10 year post.
Measured: collect retrospectively from medical record preoperative and if done preoperatively at 1 year, 5 year and 10 year follow up visits
Adverse Events
Adverse events will be collected to monitor the safety, retrospectively from medical record review starting with operative date through end of study
Measured: through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completion16 Apr 2020
- Study completion16 Apr 2020
Why it stopped: The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the REDAPT 15 study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasties, Hip ReplacementStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachel Jahnke, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661620
- Sponsor's protocol ID
- REDAPT 15-4538-02
- Status last verified
- Apr 2024
- First submitted
- 12 Jan 2016
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective-Prospective Study of REDAPT™ Revision Femoral System Modular Stem
- ClinicalTrials.gov ID
- NCT02661620
- Acronym / sponsor ID
- REDAPT 15-4538-02
- Conditions
- Arthroplasties, Hip Replacement
- Keywords
- REDAPT Femoral System modular stem implant, Total Hip arthroplasty revision
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the REDAPT 15 study.
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 22 Jan 2016 (estimated)
- 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.
A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market performance and safety of the study device. The study will collect retrospective data from medical records review and prospective data from observations data at 5 and 10 postoperatively clinical visits. There will also be a 7.5 year telephone follow up contact to assess for device status and adverse events.
Detailed description
The primary purpose of this study is to demonstrate the REDAPT™ Revision Femoral System modular stem cumulative revision rate at 5 years.
The secondary purpose of this study is to provide 10 years of safety and performance data on the REDAPT™ Revision Femoral System modular stem in terms of Standard of Care Radiographic Assessment, Harris Hip Sore (if obtained prior to implant), adverse event assessment, whole blood metal ion level assessment for Cobalt and Chromium (only performed if subject if symptomatic with pain, swelling, and/or functional limitation related to the device and/ implant procedure as assessed by the Principal Investigator (PI), and Metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) or Computed Tomography (CT) will be obtained if metal ion levels of Cobalt and/or Chromium > 7parts per billion (ppb) 140 subjects have been enrolled in the study at 5 clinical study sites around the world. A Clinical Study Report (CSR) will be completed at years 5 and 10.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subject has undergone revision hip arthroplasty with the REDAPT™ Revision Femoral System modular stem with implantation from 2012 to the date of Institutional Review Board (IRB)/Ethics Committee (EC) approval of this protocol at the study site.
Key inclusion criteria (10 listed)
- Subject has undergone revision hip arthroplasty with the REDAPT™ Revision Femoral System modular stem with implantation from 2012 to the date of Institutional Review Board (IRB)/Ethics Committee (EC) approval ofthe original version 1.0 protocol at the study site.
- Subject completed limited retrospective data collection phase and willing to consent to expanded retrospective data collection and the prospective phase of the study;
- Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.
- Not applicable
- Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse; or
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| REDAPT Revision Femoral System modular stemMedical record review for retrospective information and observational prospective data collection of standard of care items at 5 years and 10 years post operatively plus a 7.5 year post op telephone call to assess stem status and adverse events. | Device | – |
Primary outcome
Modular stem revision
Time frame: 5 years post operatively
Listing of stem implant status at 5 years to analyze stem survival rate
4 secondary outcomes
Revision of any component for any reason
Time frame: 5 year post operative
Radiographic assessments
Time frame: follow-up to 10 years as per standard of care
Harris Hip Score
Time frame: collect retrospectively from medical record preoperative and if done preoperatively at 1 year, 5 year and 10 year follow up visits
Adverse Events
Time frame: through study completion, an average of 10 years
Results and safety
The study was stopped early (reason given: The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the REDAPT 15 study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Rachel Jahnke study chair
Smith & Nephew, Inc.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasties, Hip Replacement, run by Smith & Nephew, Inc. at 5 sites in 3 countries.
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 10 inclusion and 0 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: stopped early, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, 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 was stopped early (reason given: The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the REDAPT 15 study.). Results are not available in the source record.
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?
Modular stem revision (time frame: 5 years post operatively). 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 2 Apr 2024.