Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular SystemNCT01672086
Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System
An observational study of Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System, run by StelKast, Inc. at 4 sites in United States.
Trial summary
The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a retrospective, multi-center, single-arm study intended to collect data on the survivorship and long-term safety and effectiveness of the device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System
- What is being tested?
- Stelkast Surpass Acetabular System implant
- Type of treatment
- Medical device
- How many people
- 347 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2012to Jun 2016
- 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: All patients treated with the Stelkast Surpass Acetabular System at the participating siteswill be included in the evaluation.
Who may be able to join
- Primary hip arthroplasty
- Skeletal maturity
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis
Who cannot join
- The Stelkast Surpass Acetabular System is contraindicated in patients with the following conditions: Overt or latent infection in or around the hip joint, insufficient bone stock to allow appropriate insertion and fixation of the prosthesis, insufficient soft tissue integrity to provide adequate stability, muscle laxity or inadequate soft tissue for proper function and healing, mental or neuromuscular disorders that do not allow control of the affected joint, revision hip arthroplasty, inflammatory hip joint disease, and neuropathic hip joint disease.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mutschler Orthopedic Institute
Canonsburg, Pennsylvania, 15317
Gill Orthopedic Clinic
Charlotte, North Carolina, 28207
Premier Orthopedics and SPM Associates
Glen Mills, Pennsylvania, 19342
The Rothman Institute
Philadelphia, Pennsylvania, 19107
About this study
The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a retrospective, multi-center, single-arm study intended to collect data on the survivorship and long-term safety and effectiveness of the device.
Read the detailed description
This active surveillance study is intended to evaluate the survivorship and long-term safety and effectiveness of the Stelkast Surpass Acetabular System. Neither the patient nor the surgeon are blinded to treatment. The study will compare the Surpass' survivorship to the survivorship observed in a historical control group established by a meta-analysis. The evaluation will be conducted for a period of ten years. These evaluations will be recorded through onsite visits and/or mailings sent to physicians requesting deidentified patient-level data for subjects implanted with the Surpass system.
- Conditions
- Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System
- Being tested
- Stelkast Surpass Acetabular System implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stelkast Surpass Acetabular System implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Stelkast Surpass Patients | Not described Receives: Device: Stelkast Surpass Acetabular System implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Product is no longer being manufactured and marketed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular SystemStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- StelKast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abigail Allen, Study director, MCRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672086
- Sponsor's protocol ID
- 344-01
- Status last verified
- Oct 2016
- First submitted
- 21 Aug 2012
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System
- ClinicalTrials.gov ID
- NCT01672086
- Acronym / sponsor ID
- 344-01
- Conditions
- Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Product is no longer being manufactured and marketed.
- Enrolment
- 347 participants (actual)
- Lead sponsor
- StelKast, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Aug 2012 (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 active surveillance post-approval study of the Stelkast Surpass Acetabular System is a retrospective, multi-center, single-arm study intended to collect data on the survivorship and long-term safety and effectiveness of the device.
Detailed description
This active surveillance study is intended to evaluate the survivorship and long-term safety and effectiveness of the Stelkast Surpass Acetabular System. Neither the patient nor the surgeon are blinded to treatment. The study will compare the Surpass' survivorship to the survivorship observed in a historical control group established by a meta-analysis. The evaluation will be conducted for a period of ten years. These evaluations will be recorded through onsite visits and/or mailings sent to physicians requesting deidentified patient-level data for subjects implanted with the Surpass system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stelkast Surpass Patients | – | Device: Stelkast Surpass Acetabular System implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with the Stelkast Surpass Acetabular System at the participating siteswill be included in the evaluation.
Key inclusion criteria (3 listed)
- Primary hip arthroplasty
- Skeletal maturity
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis
Key exclusion criteria (1 listed)
- The Stelkast Surpass Acetabular System is contraindicated in patients with the following conditions: Overt or latent infection in or around the hip joint, insufficient bone stock to allow appropriate insertion and fixation of the prosthesis, insufficient soft tissue integrity to provide adequate stability, muscle laxity or inadequate soft tissue for proper function and healing, mental or neuromuscular disorders that do not allow control of the affected joint, revision hip arthroplasty, inflammatory hip joint disease, and neuropathic hip joint disease.
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 |
|---|---|---|
| Stelkast Surpass Acetabular System implant | Device | Stelkast Surpass Patients |
Primary outcome
Survivorship
Time frame: 10 Years
Results and safety
The study was stopped early (reason given: Product is no longer being manufactured and marketed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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.
Abigail Allen study director
MCRA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System, run by StelKast, Inc. at 4 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 3 inclusion and 1 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 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study was stopped early (reason given: Product is no longer being manufactured and marketed.). 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?
Survivorship (time frame: 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 13 Oct 2016.