OsteoarthritisPhase 4NCT01028469
Artelon Metatarsophalangeal (MTP) Spacer
A Phase 4 study testing Artelon MTP Spacer in people with Osteoarthritis and Hallux Rigidus, run by Artimplant AB at 1 site in Sweden.
Trial summary
The aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Hallux Rigidus
- What is being tested?
- Artelon MTP Spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2009to Dec 2011
- Phase
- Phase 4
- 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
Who may be able to join
- The patient experiences pain and limitations of the great toe dorsiflexion at the MTP-I joint.
- The patient has a clinically and radiographically verified arthritis in the MTP-I joint indicating the need for surgical treatment.
- The patient reads, understands and is able to complete the study questionnaires in Swedish.
- The patient has received written and oral information regarding the study and has signed the informed consent form.
Who cannot join
- The patient has a pronounced hallux rigidus without mobility in the MTP-I joint (ROM = 0°).
- The patient has previously received surgical treatment affecting the anatomy of the MTP-I joint.
- The patient has a systemic rheumatic disease, ongoing infection, hallux valgus or is seriously ill.
Trial locations and contacts
1 site in 1 country.
Martin Alund, M.D. contact
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset, Område Ortopedi, Mölndal
Mölndal
About this study
Official title: Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus
The aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.
- Conditions
- Osteoarthritis, Hallux Rigidus
- Being tested
- Artelon MTP Spacer
- Medical subject headings
- Osteoarthritis, Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artelon MTP SpacerDevice
Metatarsophalangeal hemi-implant
| Study group | Role | What they receive |
|---|---|---|
| Artelon MTP Spacer | Experimental | Metatarsophalageal hemi-implant Receives: Device: Artelon MTP Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system.
Measured: pre-treatment and 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2011 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artimplant AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Alund, M.D., Principal investigator, Sahlgrenska University Hospital, Mölndal, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028469
- Sponsor's protocol ID
- KP026
- Status last verified
- Dec 2009
- First submitted
- 8 Dec 2009
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus
- ClinicalTrials.gov ID
- NCT01028469
- Acronym / sponsor ID
- KP026
- Conditions
- Osteoarthritis, Hallux Rigidus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Artimplant ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (estimated)
- First posted
- 9 Dec 2009 (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 aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artelon MTP Spacer | Experimental | Device: Artelon MTP SpacerMetatarsophalageal hemi-implant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The patient experiences pain and limitations of the great toe dorsiflexion at the MTP-I joint.
- The patient has a clinically and radiographically verified arthritis in the MTP-I joint indicating the need for surgical treatment.
- The patient reads, understands and is able to complete the study questionnaires in Swedish.
- The patient has received written and oral information regarding the study and has signed the informed consent form.
Key exclusion criteria (3 listed)
- The patient has a pronounced hallux rigidus without mobility in the MTP-I joint (ROM = 0°).
- The patient has previously received surgical treatment affecting the anatomy of the MTP-I joint.
- The patient has a systemic rheumatic disease, ongoing infection, hallux valgus or is seriously ill.
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 |
|---|---|---|
| Artelon MTP SpacerMetatarsophalangeal hemi-implant | Device | Artelon MTP Spacer |
Primary outcome
Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system.
Time frame: pre-treatment and 12 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
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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.
Martin Alund, M.D. contact
Martin Alund, M.D. principal investigator
Sahlgrenska University Hospital, Mölndal, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artelon MTP Spacer in people with Osteoarthritis and Hallux Rigidus, run by Artimplant AB at 1 site in Sweden.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Dec 2009. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Alund, M.D. (martin.alund@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system. (time frame: pre-treatment and 12 months post-op). 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 15 Dec 2009.