OsteoarthritisNCT01107340
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
A study testing AMIStem Hip System in people with Osteoarthritis and Arthritis, run by Medacta International SA at 2 sites in 2 countries.
Trial summary
This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Arthritis, Avascular Necrosis
- What is being tested?
- AMIStem Hip System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2010to Jan 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is a good candidate for a primary hip arthroplasty using AMIStem Hip System
- Patient is willing and able to give informed consent to participate in the follow-up program
- Patient is suitable for surgery and able to participate in the follow-up program.
- Those presenting with disease that meets the indication for use for Medacta implants defined in the study (on-label use)
Who cannot join
- Acute systemic or chronic infection
- Skeletal immaturity
- Severe muscular, neurological, vascular deficiency or other pathologies of the affected limb that may compromise the stability of the implant.
- Bone condition that may compromise the stability of the implant.
- Patient who are unwilling or unable to give consent, or to comply with the protocol and the follow-up program.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
The Elective Orthopaedic Centre (EOC)
Epsom, Surrey, KT18 7EG
About this study
This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.
- Conditions
- Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia
- Being tested
- AMIStem Hip System
- Medical subject headings
- Osteoarthritis, Arthritis, Osteonecrosis, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMIStem Hip SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| AMIStem Hip System | Other | Patients who comply with the protocol and received an AMIStem femoral component. Receives: Device: AMIStem Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of implant survivorship using Kaplan Meier curve
Measured: 10 years after surgery
Secondary outcomes (4)
Assessment of the patient's physical level of activity using the Oxford Hip Score
Measured: pre-op, annually post-op up to 10 years
Assessment of the improvement in quality of life and joint movement using the EuroQol-5D score
Measured: pre-op, annually post-op up to 10 years
Assessment of implant survivorship as a measure of safety using Kaplan Meier curve
Measured: 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery
Assessment of the clinical outcome following total hip replacement using the Harris Hip Score
Measured: pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard E Field, PhD FRCS, Principal investigator, British Orthopaedic Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107340
- Sponsor's protocol ID
- P01.004.11
- Status last verified
- Dec 2024
- First submitted
- 15 Apr 2010
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
- ClinicalTrials.gov ID
- NCT01107340
- Acronym / sponsor ID
- P01.004.11
- Conditions
- Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2010 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 20 Apr 2010 (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.
This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMIStem Hip System | Other | Device: AMIStem Hip SystemPatients who comply with the protocol and received an AMIStem femoral component. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is a good candidate for a primary hip arthroplasty using AMIStem Hip System
- Patient is willing and able to give informed consent to participate in the follow-up program
- Patient is suitable for surgery and able to participate in the follow-up program.
- Those presenting with disease that meets the indication for use for Medacta implants defined in the study (on-label use)
Key exclusion criteria (5 listed)
- Acute systemic or chronic infection
- Skeletal immaturity
- Severe muscular, neurological, vascular deficiency or other pathologies of the affected limb that may compromise the stability of the implant.
- Bone condition that may compromise the stability of the implant.
- Patient who are unwilling or unable to give consent, or to comply with the protocol and the follow-up program.
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 |
|---|---|---|
| AMIStem Hip System | Device | AMIStem Hip System |
Primary outcome
Assessment of implant survivorship using Kaplan Meier curve
Time frame: 10 years after surgery
4 secondary outcomes
Assessment of the patient's physical level of activity using the Oxford Hip Score
Time frame: pre-op, annually post-op up to 10 years
Assessment of the improvement in quality of life and joint movement using the EuroQol-5D score
Time frame: pre-op, annually post-op up to 10 years
Assessment of implant survivorship as a measure of safety using Kaplan Meier curve
Time frame: 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery
Assessment of the clinical outcome following total hip replacement using the Harris Hip Score
Time frame: pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery
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 16 Dec 2024.
Related trials for Osteoarthritis
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
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.
Richard E Field, PhD FRCS principal investigator
British Orthopaedic Association
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMIStem Hip System in people with Osteoarthritis and Arthritis, run by Medacta International SA at 2 sites in 2 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 4 inclusion and 5 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland, United Kingdom. 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?
Assessment of implant survivorship using Kaplan Meier curve (time frame: 10 years after surgery). 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 2024.