Hallux ValgusNCT03133039
A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery
A study testing surgery, bioabsorbable screw in people with Hallux Valgus and Hallux Rigidus, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The investigators sought to determine whether bioabsorbable cannulated screws could perform as well as titanium cannulated screws in the Lapidus procedure and MTP1-joint arthorodesis in anatomical models and clinical series of the foot. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus, Hallux Rigidus
- What is being tested?
- surgery, bioabsorbable screw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2015to 1 Dec 2021
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- valuntary 18-65-yers-old, patient have hallux valgus or hallux rigidus deformity which need surgery treatment
Who cannot join
- Over 65 yers-old or less than 18-years-old, diabetes, rheumatism, smoker or lack of co-operation
Trial locations and contacts
1 site in 1 country.
Heikki Mäenpää, M.D, Ph.D. contact
Finland1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Tampere, Pirkanmaa, FI-33014
Nikke Partio, M.D., +358 3 355 111, nikke.partio@tuni.fi
About this study
Official title: Comparative Experimental and Clinical Study: a New Type of Bioabsorbable Screw and the Titanium Screw in the Hallux Valgus Surgery
The investigators sought to determine whether bioabsorbable cannulated screws could perform as well as titanium cannulated screws in the Lapidus procedure and MTP1-joint arthorodesis in anatomical models and clinical series of the foot.
- Conditions
- Hallux Valgus, Hallux Rigidus
- Being tested
- surgery, bioabsorbable screw
- Medical subject headings
- Hallux Valgus, Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery, bioabsorbable screwProcedure or surgery
In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery
| Study group | Role | What they receive |
|---|---|---|
| bioabsorbable screw | Active comparator | Not described Receives: Procedure: surgery, bioabsorbable screw |
| titanium screw | Active comparator | Not described Receives: Procedure: surgery, bioabsorbable screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS score
score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Oct 2015
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikke Partio, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133039
- Sponsor's protocol ID
- R16143
- Status last verified
- Aug 2019
- First submitted
- 25 Apr 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Partio N, Mattila V, Waris V, Maenpaa H. Bioabsorbable vs. titanium screws in first metatarsophalangeal joint arthrodesis: a pilot randomized controlled trial with 2-year follow-up. Arch Orthop Trauma Surg. 2026 Sep 9;146(1):329. doi: 10.1007/s00402-026-06501-2.
PubMed 42714616
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Experimental and Clinical Study: a New Type of Bioabsorbable Screw and the Titanium Screw in the Hallux Valgus Surgery
- ClinicalTrials.gov ID
- NCT03133039
- Acronym / sponsor ID
- R16143
- Conditions
- Hallux Valgus, Hallux Rigidus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 28 Apr 2017 (actual)
- 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 investigators sought to determine whether bioabsorbable cannulated screws could perform as well as titanium cannulated screws in the Lapidus procedure and MTP1-joint arthorodesis in anatomical models and clinical series of the foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bioabsorbable screw | Active comparator | Procedure: surgery, bioabsorbable screw |
| titanium screw | Active comparator | Procedure: surgery, bioabsorbable screw |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- valuntary 18-65-yers-old, patient have hallux valgus or hallux rigidus deformity which need surgery treatment
Key exclusion criteria (1 listed)
- Over 65 yers-old or less than 18-years-old, diabetes, rheumatism, smoker or lack of co-operation
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 |
|---|---|---|
| surgery, bioabsorbable screwIn this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery | Procedure or surgery | bioabsorbable screw, titanium screw |
Primary outcome
AOFAS score
Time frame: 2 years
score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 42714616Partio N, Mattila V, Waris V, Maenpaa H. Bioabsorbable vs. titanium screws in first metatarsophalangeal joint arthrodesis: a pilot randomized controlled trial with 2-year follow-up. Arch Orthop Trauma Surg. 2026 Sep 9;146(1):329. doi: 10.1007/s00402-026-06501-2.
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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.
Heikki Mäenpää, M.D, Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery, bioabsorbable screw in people with Hallux Valgus and Hallux Rigidus, run by Tampere University Hospital at 1 site in Finland.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nkke Partio, M.D (+3583 311611, partio.nikke.n@student.uta.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133039, which also lists 1 linked publication.
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 28 Aug 2019.