Total Hip Arthroplasty (THA)NCT02344160
REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness
An observational study of Total Hip Arthroplasty (THA), run by Smith & Nephew, Inc. at 1 site in United States.
Trial summary
The objective of the study is to demonstrate non-inferiority of stem revision rate in subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5 year mark assuming an observed rate of 6.5% at 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Phlebotomy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 340 subjects
Who may be able to join
- Subject requires revision hip arthroplasty
- Subject requires subsequent revision of a joint replacement that involves the insertion, removal and/or replacement of a prosthesis or implant
- Subjects with inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
- Treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
- Endoprosthesis, femoral osteotomy, or Girdlestone resection
- Subject is at least 18 years of age
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- Subject is skeletally mature in Investigators judgment
- Subject is willing to consent to participate in the study
- Subject is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk
Who cannot join
- Known allergies to any components of the devices
- Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation
- Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits
- Subject is facing current or impending incarceration
- Female subject is of child-bearing age and not using an approved method of contraception
- Mental or neurological conditions which could impair the subject's ability or willingness to comply with the study
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- Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.
- Skeletal immaturity
- Subject is severely overweight (BMI > 40)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-center Consecutive Series Study of Subjects Treated With the REDAPT™ Revision Femoral System
The objective of the study is to demonstrate non-inferiority of stem revision rate in subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5 year mark assuming an observed rate of 6.5% at 5 years. Additional data will be collected as outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.
Read the detailed description
This study is a prospective, multi-center, consecutive series study of subjects treated with REDAPT™. The safety and effectiveness of the REDAPT™ revision stem will be assessed over a maximum of 5 years with additional follow up to 10 years to assess outcomes. The objective of this study is to establish if the REDAPT™ stem revision rate is less than 9.8% at 5 years with an observed rate from literature review of 6.5% at 5 year.
- Conditions
- Total Hip Arthroplasty (THA)
- Being tested
- Phlebotomy
- Keywords
- Total Hip Arthroplasty, THA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotomyOther
Also called blood draw
Phlebotomy will be performed at study follow up visits to obtain blood for metal ion analysis which will monitor levels for safety outcome measures
What is being measured
The primary outcome is the main question the study is designed to answer.
Stem revision
the primary outcome will be assessed by the incidence of stem revision
Measured: 5 years with additional follow up to 10 years
Secondary outcomes (6)
Revision for any reason
Revision for any reason
Measured: 5 years with additional follow-up to 10 years
Radiographic Measurements
radiographic measurements to assess linear radiolucencies and subsidence to assess safety and potential change over time.
Measured: post operatively with additional follow-up to 10 years
Hip Disability and Osteoarthritis Outcome Score (HOOS) and Euro Group Questionnaire (EQ-5D)
Subject reported outcomes will be collected and scored over time to assess change over time from baseline to 10 year post REDAPT Revision surgery
Measured: At baseline and up to 10 year follow up
Harris Hip Score
Clinical evaluations to score and assess changes over time from baseline to 10 year follow up post REDAPT Revision surgery
Measured: at baseline and follow up visits up to 10 year follow up post surgically
Number of participants with Adverse Events
Adverse events will be collected to monitor safety
Measured: Adverse events will be collected and assessed as safety out come at each study visit up to 10 years post surgery
Metal Ion measurement in whole blood
blood will be analysed for metal ion levels at baseline and each study visit up to 10 years to assess change in serum metal ion level over time.
Measured: baseline and at each study visit up to 10 years following REDAPT REvison surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Unable to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Waddell, MD, Principal investigator, St. Michaels Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344160
- Sponsor's protocol ID
- 13-4538-02
- Status last verified
- Dec 2016
- First submitted
- 14 Jan 2015
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Consecutive Series Study of Subjects Treated With the REDAPT™ Revision Femoral System
- ClinicalTrials.gov ID
- NCT02344160
- Acronym / sponsor ID
- 13-4538-02
- Conditions
- Total Hip Arthroplasty (THA)
- Keywords
- Total Hip Arthroplasty, THA
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to recruit subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jan 2015 (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.
The objective of the study is to demonstrate non-inferiority of stem revision rate in subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5 year mark assuming an observed rate of 6.5% at 5 years. Additional data will be collected as outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.
Detailed description
This study is a prospective, multi-center, consecutive series study of subjects treated with REDAPT™. The safety and effectiveness of the REDAPT™ revision stem will be assessed over a maximum of 5 years with additional follow up to 10 years to assess outcomes. The objective of this study is to establish if the REDAPT™ stem revision rate is less than 9.8% at 5 years with an observed rate from literature review of 6.5% at 5 year.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 340 subjects
Key inclusion criteria (9 listed)
- Subject requires revision hip arthroplasty
- Subject requires subsequent revision of a joint replacement that involves the insertion, removal and/or replacement of a prosthesis or implant
- Subjects with inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
- Treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
- Endoprosthesis, femoral osteotomy, or Girdlestone resection
Key exclusion criteria (9 listed)
- Known allergies to any components of the devices
- Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation
- Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits
- Subject is facing current or impending incarceration
- Female subject is of child-bearing age and not using an approved method of contraception
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 |
|---|---|---|
| PhlebotomyAlso: blood drawPhlebotomy will be performed at study follow up visits to obtain blood for metal ion analysis which will monitor levels for safety outcome measures | Other | – |
Primary outcome
Stem revision
Time frame: 5 years with additional follow up to 10 years
the primary outcome will be assessed by the incidence of stem revision
6 secondary outcomes
Revision for any reason
Time frame: 5 years with additional follow-up to 10 years
Radiographic Measurements
Time frame: post operatively with additional follow-up to 10 years
Hip Disability and Osteoarthritis Outcome Score (HOOS) and Euro Group Questionnaire (EQ-5D)
Time frame: At baseline and up to 10 year follow up
Harris Hip Score
Time frame: at baseline and follow up visits up to 10 year follow up post surgically
Number of participants with Adverse Events
Time frame: Adverse events will be collected and assessed as safety out come at each study visit up to 10 years post surgery
Metal Ion measurement in whole blood
Time frame: baseline and at each study visit up to 10 years following REDAPT REvison surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
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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.
James Waddell, MD principal investigator
St. Michaels Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty (THA), run by Smith & Nephew, Inc. at 1 site in United States.
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 9 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: withdrawn, as of the sponsor's last update on 16 Dec 2016. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Stem revision (time frame: 5 years with additional follow up to 10 years). 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 16 Dec 2016.