Arthroplasty, Replacement, HipNCT00957658
Accolade® TMZF® Hip Stem Outcomes Study
A study testing Accolade® TMZF® Hip Stem in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Accolade® TMZF® Hip Stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2006to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a candidate for a primary total hip replacement.
- Patient has primary diagnosis of osteoarthritis (OA).
- Male and non-pregnant female patients ages 18 to 90.
- Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
- Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.
Who cannot join
- Patient has an active infection within the affected hip joint.
- Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- Patient who is morbidly obese, Body Mass Index (BMI) > 40.
- Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
- Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
- Patient is a prisoner.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Orthopaedic Surgery Associates
Boynton Beach, Florida, 33435
Coastal Orthopaedics
Bradenton, Florida, 34209
Hughston Clinic P.A.
Columbus, Georgia, 31908
Plymouth Bay Ortho Association
Duxbury, Massachusetts, 02332
Specialty Orthopaedics
Harrison, New York, 10528
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Newport Orthopaedic Institute
Newport Beach, California, 92660
Alvarado Ortho Medical Group
San Diego, California, 92120
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 23907
New England Orthopaedic Surgeons
Springfield, Massachusetts, 01107
Northwest Orthopaedic Institute
Tacoma, Washington, 98402
About this study
Official title: Accolade® TMZF® Study A Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade® TMZF® Hip Stem
The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.
Read the detailed description
A prospective, post-market, multi-centered clinical evaluation of the Accolade® TMZF® hip stem device. All patients enrolled will receive the study device. All study patients will undergo a preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone mineral density (BMD) values.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Accolade® TMZF® Hip Stem
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accolade® TMZF® Hip StemDevice
Accolade® TMZF® Hip Stem
| Study group | Role | What they receive |
|---|---|---|
| Accolade® TMZF® Hip Stem | Other | Accolade® TMZF® Hip Stem Study Device Receives: Device: Accolade® TMZF® Hip Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain
Measured: 2 years
Secondary outcomes (9)
Percentage (%) of Hip Stems With Aseptic Loosening
Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view.
Measured: 5 years
Revision/Removal Rates
The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals.
Measured: 2 and 5 years
Change in Harris Hip Score (HHS)
The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.
Measured: Preoperative, 2 and 5 years
Change in SF-12 Score
The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Measured: Preoperative, 2 and 5 years
Change in Lower Extremity Activity Scale (LEAS) Score
The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement.
Measured: Preoperative, 2 and 5 years
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.
EXPECTATIONS KEY:
Participate in recreational activities (dancing,traveling,gardening)
Exercise or participate in sports
Independently perform household chores/daily routine
Easily change position,sit to stand/stand to sit
Remove need for cane crutch or walker
Use stairs normally step by step
Ability to sleep through night
Maintain social activites,caring for someone,playing with children
Use public transportation or drive
Maintain psychological well-being
Maintain sexual activity
Maintain employment
Measured: 6 months, 1 year and 2 years
PEQ (Patient Evaluation Questionnaire) Percent Achievement
The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.
EXPECTATIONS KEY:
Participate in recreational activities (dancing,traveling,gardening)
Exercise or participate in sports
Independently perform household chores/daily routine
Easily change position,sit to stand/stand to sit
Remove need for cane crutch or walker
Use stairs normally step by step
Ability to sleep through night
Maintain social activites,caring for someone,playing with children
Use public transportation or drive
Maintain psychological well-being
Maintain sexual activity
Maintain employment
Measured: 6 months, 1 year, 2 years
Acetabular Insert Wear
The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.
Measured: 5 years
Wrist DXA Scan Analysis
DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startMar 2006
- Primary completionMay 2011
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Krushell, MD, Study chair, Baystate Medical CenterCarlton Savory, MD, Principal investigator, Hughston Sports Medicine CenterRobert Zann, MD, Principal investigator, Boca Raton Community HospitalSteven Gausewitz, MD, Principal investigator, Hoag HospitalR. Scott Oliver, MD, Principal investigator, Jordan HospitalMary O'Connor, MD, Principal investigator, Mayo ClinicAnthony Sanchez, MD, Principal investigator, Spartanburg Regional Health Service District, IncMark Visk, MD, Principal investigator, Spartanburg Regional Health Service District, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957658
- Sponsor's protocol ID
- 59
- Status last verified
- Jul 2016
- First submitted
- 10 Aug 2009
- Last updated
- 14 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accolade® TMZF® Study A Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade® TMZF® Hip Stem
- ClinicalTrials.gov ID
- NCT00957658
- Acronym / sponsor ID
- 59
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.
Detailed description
A prospective, post-market, multi-centered clinical evaluation of the Accolade® TMZF® hip stem device. All patients enrolled will receive the study device. All study patients will undergo a preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone mineral density (BMD) values.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accolade® TMZF® Hip Stem | Other | Device: Accolade® TMZF® Hip StemAccolade® TMZF® Hip Stem Study Device |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is a candidate for a primary total hip replacement.
- Patient has primary diagnosis of osteoarthritis (OA).
- Male and non-pregnant female patients ages 18 to 90.
- Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Key exclusion criteria (7 listed)
- Patient has an active infection within the affected hip joint.
- Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- Patient who is morbidly obese, Body Mass Index (BMI) > 40.
- Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
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 |
|---|---|---|
| Accolade® TMZF® Hip StemAccolade® TMZF® Hip Stem | Device | Accolade® TMZF® Hip Stem |
Primary outcome
Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain
Time frame: 2 years
9 secondary outcomes
Percentage (%) of Hip Stems With Aseptic Loosening
Time frame: 5 years
Revision/Removal Rates
Time frame: 2 and 5 years
Change in Harris Hip Score (HHS)
Time frame: Preoperative, 2 and 5 years
Change in SF-12 Score
Time frame: Preoperative, 2 and 5 years
Change in Lower Extremity Activity Scale (LEAS) Score
Time frame: Preoperative, 2 and 5 years
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Time frame: 6 months, 1 year and 2 years
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Time frame: 6 months, 1 year, 2 years
Acetabular Insert Wear
Time frame: 5 years
Wrist DXA Scan Analysis
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Krushell, MD study chair
Baystate Medical Center
Carlton Savory, MD principal investigator
Hughston Sports Medicine Center
Robert Zann, MD principal investigator
Boca Raton Community Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accolade® TMZF® Hip Stem in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 11 sites 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 6 inclusion and 7 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain (time frame: 2 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 14 Aug 2017.