Hallux ValgusNCT05534724
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
A study testing Partial weight-bearing (10 - 15kg) and Complete weight-bearing in people with Hallux Valgus and Orthopedic Disorder, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
This is a two-arm randomized controlled trial with the aim to evaluate the effectiveness and safety of post-operative management after a modified Lapidus arthrodesis with/without an Akin or a Weil/Hohmann surgery fusion with immediate complete weight-bearing compared with partial weight-bearing (10 - 15kg) for 6 weeks… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus, Orthopedic Disorder
- What is being tested?
- Partial weight-bearing (10 - 15kg) and Complete weight-bearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Jan 2023to 1 Jul 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient who undergo modified Lapidus arthrodesis operation and associated with:
- Additional surgical gestures such as e.g. interventions on the proximal phalanx of the first finger (Akin) or interventions on the 2nd and / or 3rd ray (Weil / Hohmann) [23,24].
- Willingness and ability to participate in the trial
- Signed Informed Consent
Who cannot join
- Diabetes mellitus
- Rheumatoid arthritis
- Previous foot surgery
- Classic Lapidus surgery
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
- Inability or contraindications to undergo the investigated intervention
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
EOC
Lugano, 6900
Martin Riegger, Dr.med, +41 (0) 91 811 70 29, RicercaOrtopedia.ORL@eoc.ch
About this study
Official title: Is Full Weight Bearing After the Modified Lapidus Operation Possible? A Randomized Controlled Trial to Compare Early and Partial Weight-bearing
This is a two-arm randomized controlled trial with the aim to evaluate the effectiveness and safety of post-operative management after a modified Lapidus arthrodesis with/without an Akin or a Weil/Hohmann surgery fusion with immediate complete weight-bearing compared with partial weight-bearing (10 - 15kg) for 6 weeks as a novel approach for rehabilitation after a foot surgery.
Read the detailed description
The surgical operation will be carried out according to the standard clinical practice, namely following the modified Lapidus general and specific rules concerning the surgical treatment of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion. Post-operatively, patients who meet the eligibility criteria will be randomized into one of the two groups (partial weight-bearing limited at 15kg vs full weight-bearing) Patient in both groups will be wearing a VACOPASO shoe for 6 weeks.
Standard X-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at weeks 6, 12, 24.
Change in pain severity from the day of surgery to 6, 12 and 24 weeks postoperatively will be measured using the pain Visual Analogue Scale (VAS). Quality of life will be assessed through the American Orthopedic Foot and Ankle Score (AOFAS). Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS).
- Conditions
- Hallux Valgus, Orthopedic Disorder
- Being tested
- Partial weight-bearing (10 - 15kg), Complete weight-bearing
- Keywords
- Quality of life, Bone consolidation, Foot surgery, Lapidus surgery, Weil surgery, Hohmann surgery, Akin surgery
- Medical subject headings
- Hallux Valgus, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial weight-bearing (10 - 15kg)Other
Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks
Complete weight-bearingOther
Complete post-operative weight-bearing with a VACOPASO shoe for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Partial weight-bearing (10 - 15kg) | Other | Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks, crutches and antithrombotic prophylaxis Receives: Other: Partial weight-bearing (10 - 15kg) |
| Complete weight-bearing | Experimental | Immediate post-operative complete weight-bearing with a VACOPASO shoe for 6 weeks and antithrombotic prophylaxis Receives: Other: Complete weight-bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)
The Olerud and Molander Ankle Score (OMAS) is a functional rating scale from 0 to 100 and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and activities of daily living. Higher scores mean a better outcome.
Measured: at 6 weeks
Secondary outcomes (4)
Pain on a Visual Analogue Scale
Change in pain severity postoperatively measured using the pain Visual Analogue Scale (VAS).
The pain VAS scale is a validated, self-assessment scale in which patients rate their pain by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10).
Measured: At the day of surgery, at 6, 12 and 24 weeks postoperatively.
Bone consolidation through anteroposterior and lateral foot x-rays
Incidence of bone consolidation (bone callus formation) assessed in an objective measure by the radiologist
Measured: 6 weeks and 12 weeks. At 24 weeks in case of fracture non-union reported at the 12th week postoperatively
American Orthopedic Foot and Ankle Score questionnaire
The American Orthopedic Foot and Ankle Score (AOFAS) is used find the quality of life index for foot-and-ankle pathologies. It is made of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Higher scores mean a better outcome.
Measured: at 6, 12 and 24 weeks
Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)
Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS).
The Olerud and Molander Ankle Score (OMAS) [7] is a functional rating scale from 0 to 100 and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and activities of daily living. Higher scores mean a better outcome.
Measured: at 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start19 Jan 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The surgical operation will be the modified Lapidus arthrodesis of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion. Post-operatively, patients will be randomized into one of the two groups: * Group A (control intervention): immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO for 6 weeks, crutches and antithrombotic prophylaxis. * Group B (experimental intervention): immediate post-operative complete weight-bearing with a VACOPASO for 6 weeks and antithrombotic prophylaxis.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Riegger, MD, Principal investigator, EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534724
- Sponsor's protocol ID
- ORL-ORT-033
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.
PubMed 6437370LAPIDUS PW. A quarter of a century of experience with the operative correction of the metatarsus varus primus in hallux valgus. Bull Hosp Joint Dis. 1956 Oct;17(2):404-21. No abstract available.
PubMed 13413410Butson AR. A modification of the Lapidus operation for hallux valgus. J Bone Joint Surg Br. 1980 Aug;62(3):350-2. doi: 10.1302/0301-620X.62B3.6997319.
PubMed 6997319Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. doi: 10.1177/107110079401500701.
PubMed 7951968Drummond D, Motley T, Kosmopoulos V, Ernst J. Stability of Locking Plate and Compression Screws for Lapidus Arthrodesis: A Biomechanical Comparison of Plate Position. J Foot Ankle Surg. 2018 May-Jun;57(3):466-470. doi: 10.1053/j.jfas.2017.10.025. Epub 2018 Feb 19.
PubMed 29472168Ray RG, Ching RP, Christensen JC, Hansen ST Jr. Biomechanical analysis of the first metatarsocuneiform arthrodesis. J Foot Ankle Surg. 1998 Sep-Oct;37(5):376-85. doi: 10.1016/s1067-2516(98)80045-8.
PubMed 9798168Sangeorzan BJ, Hansen ST Jr. Modified Lapidus procedure for hallux valgus. Foot Ankle. 1989 Jun;9(6):262-6. doi: 10.1177/107110078900900602.
PubMed 2744666Myerson M, Allon S, McGarvey W. Metatarsocuneiform arthrodesis for management of hallux valgus and metatarsus primus varus. Foot Ankle. 1992 Mar-Apr;13(3):107-15. doi: 10.1177/107110079201300301.
PubMed 1601337Bednarz PA, Manoli A 2nd. Modified lapidus procedure for the treatment of hypermobile hallux valgus. Foot Ankle Int. 2000 Oct;21(10):816-21. doi: 10.1177/107110070002101004.
PubMed 11128011Saxena A, Nguyen A, Nelsen E. Lapidus bunionectomy: Early evaluation of crossed lag screws versus locking plate with plantar lag screw. J Foot Ankle Surg. 2009 Mar-Apr;48(2):170-9. doi: 10.1053/j.jfas.2008.12.009.
PubMed 19232969Blitz NM, Lee T, Williams K, Barkan H, DiDimenico LA. Early weight bearing after modified lapidus arthodesis: a multicenter review of 80 cases. J Foot Ankle Surg. 2010 Jul-Aug;49(4):357-62. doi: 10.1053/j.jfas.2010.04.014.
PubMed 20610203Kopp FJ, Patel MM, Levine DS, Deland JT. The modified Lapidus procedure for hallux valgus: a clinical and radiographic analysis. Foot Ankle Int. 2005 Nov;26(11):913-7. doi: 10.1177/107110070502601103.
PubMed 16309603Catanzariti AR, Mendicino RW, Lee MS, Gallina MR. The modified Lapidus arthrodesis: a retrospective analysis. J Foot Ankle Surg. 1999 Sep-Oct;38(5):322-32. doi: 10.1016/s1067-2516(99)80003-9.
PubMed 10553545Myerson MS, Badekas A. Hypermobility of the first ray. Foot Ankle Clin. 2000 Sep;5(3):469-84.
PubMed 11232392Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
PubMed 30211382
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Full Weight Bearing After the Modified Lapidus Operation Possible? A Randomized Controlled Trial to Compare Early and Partial Weight-bearing
- ClinicalTrials.gov ID
- NCT05534724
- Acronym / sponsor ID
- ORL-ORT-033
- Conditions
- Hallux Valgus, Orthopedic Disorder
- Keywords
- Quality of life, Bone consolidation, Foot surgery, Lapidus surgery, Weil surgery, Hohmann surgery, Akin surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 9 Sep 2022 (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.
This is a two-arm randomized controlled trial with the aim to evaluate the effectiveness and safety of post-operative management after a modified Lapidus arthrodesis with/without an Akin or a Weil/Hohmann surgery fusion with immediate complete weight-bearing compared with partial weight-bearing (10 - 15kg) for 6 weeks as a novel approach for rehabilitation after a foot surgery.
Detailed description
The surgical operation will be carried out according to the standard clinical practice, namely following the modified Lapidus general and specific rules concerning the surgical treatment of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion. Post-operatively, patients who meet the eligibility criteria will be randomized into one of the two groups (partial weight-bearing limited at 15kg vs full weight-bearing) Patient in both groups will be wearing a VACOPASO shoe for 6 weeks.
Standard X-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at weeks 6, 12, 24.
Change in pain severity from the day of surgery to 6, 12 and 24 weeks postoperatively will be measured using the pain Visual Analogue Scale (VAS). Quality of life will be assessed through the American Orthopedic Foot and Ankle Score (AOFAS). Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The surgical operation will be the modified Lapidus arthrodesis of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion. Post-operatively, patients will be randomized into one of the two groups: * Group A (control intervention): immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO for 6 weeks, crutches and antithrombotic prophylaxis. * Group B (experimental intervention): immediate post-operative complete weight-bearing with a VACOPASO for 6 weeks and antithrombotic prophylaxis.
| Arm | Type | Receives |
|---|---|---|
| Partial weight-bearing (10 - 15kg) | Other | Other: Partial weight-bearing (10 - 15kg)Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks, crutches and antithrombotic prophylaxis |
| Complete weight-bearing | Experimental | Other: Complete weight-bearingImmediate post-operative complete weight-bearing with a VACOPASO shoe for 6 weeks and antithrombotic prophylaxis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient who undergo modified Lapidus arthrodesis operation and associated with:
- Additional surgical gestures such as e.g. interventions on the proximal phalanx of the first finger (Akin) or interventions on the 2nd and / or 3rd ray (Weil / Hohmann) [23,24].
- Willingness and ability to participate in the trial
- Signed Informed Consent
Key exclusion criteria (7 listed)
- Diabetes mellitus
- Rheumatoid arthritis
- Previous foot surgery
- Classic Lapidus surgery
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
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 |
|---|---|---|
| Partial weight-bearing (10 - 15kg)Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks | Other | Partial weight-bearing (10 - 15kg) |
| Complete weight-bearingComplete post-operative weight-bearing with a VACOPASO shoe for 6 weeks | Other | Complete weight-bearing |
Primary outcome
Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)
Time frame: at 6 weeks
The Olerud and Molander Ankle Score (OMAS) is a functional rating scale from 0 to 100 and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and activities of daily living. Higher scores mean a better outcome.
4 secondary outcomes
Pain on a Visual Analogue Scale
Time frame: At the day of surgery, at 6, 12 and 24 weeks postoperatively.
Bone consolidation through anteroposterior and lateral foot x-rays
Time frame: 6 weeks and 12 weeks. At 24 weeks in case of fracture non-union reported at the 12th week postoperatively
American Orthopedic Foot and Ankle Score questionnaire
Time frame: at 6, 12 and 24 weeks
Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)
Time frame: at 12 and 24 weeks
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 11 Sep 2026.
- Background: PubMed 6437370Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.
- Background: PubMed 13413410LAPIDUS PW. A quarter of a century of experience with the operative correction of the metatarsus varus primus in hallux valgus. Bull Hosp Joint Dis. 1956 Oct;17(2):404-21. No abstract available.
- Background: PubMed 6997319Butson AR. A modification of the Lapidus operation for hallux valgus. J Bone Joint Surg Br. 1980 Aug;62(3):350-2. doi: 10.1302/0301-620X.62B3.6997319.
- Results publication: PubMed 7951968Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. doi: 10.1177/107110079401500701.
- Results publication: PubMed 29472168Drummond D, Motley T, Kosmopoulos V, Ernst J. Stability of Locking Plate and Compression Screws for Lapidus Arthrodesis: A Biomechanical Comparison of Plate Position. J Foot Ankle Surg. 2018 May-Jun;57(3):466-470. doi: 10.1053/j.jfas.2017.10.025. Epub 2018 Feb 19.
- Results publication: PubMed 9798168Ray RG, Ching RP, Christensen JC, Hansen ST Jr. Biomechanical analysis of the first metatarsocuneiform arthrodesis. J Foot Ankle Surg. 1998 Sep-Oct;37(5):376-85. doi: 10.1016/s1067-2516(98)80045-8.
- Results publication: PubMed 2744666Sangeorzan BJ, Hansen ST Jr. Modified Lapidus procedure for hallux valgus. Foot Ankle. 1989 Jun;9(6):262-6. doi: 10.1177/107110078900900602.
- Results publication: PubMed 1601337Myerson M, Allon S, McGarvey W. Metatarsocuneiform arthrodesis for management of hallux valgus and metatarsus primus varus. Foot Ankle. 1992 Mar-Apr;13(3):107-15. doi: 10.1177/107110079201300301.
- Results publication: PubMed 11128011Bednarz PA, Manoli A 2nd. Modified lapidus procedure for the treatment of hypermobile hallux valgus. Foot Ankle Int. 2000 Oct;21(10):816-21. doi: 10.1177/107110070002101004.
- Results publication: PubMed 19232969Saxena A, Nguyen A, Nelsen E. Lapidus bunionectomy: Early evaluation of crossed lag screws versus locking plate with plantar lag screw. J Foot Ankle Surg. 2009 Mar-Apr;48(2):170-9. doi: 10.1053/j.jfas.2008.12.009.
- Results publication: PubMed 20610203Blitz NM, Lee T, Williams K, Barkan H, DiDimenico LA. Early weight bearing after modified lapidus arthodesis: a multicenter review of 80 cases. J Foot Ankle Surg. 2010 Jul-Aug;49(4):357-62. doi: 10.1053/j.jfas.2010.04.014.
- Results publication: PubMed 16309603Kopp FJ, Patel MM, Levine DS, Deland JT. The modified Lapidus procedure for hallux valgus: a clinical and radiographic analysis. Foot Ankle Int. 2005 Nov;26(11):913-7. doi: 10.1177/107110070502601103.
- VACOpaso Free OPEDLink provided by the sponsor.
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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.
Martin Riegger, MD principal investigator
EOC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial weight-bearing (10 - 15kg) and Complete weight-bearing in people with Hallux Valgus and Orthopedic Disorder, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
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 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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 Switzerland. 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?
Contact Martin Riegger, MD (0041918117029, RicercaOrtopedia.ORL@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS) (time frame: at 6 weeks). 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 NCT05534724, which also lists 20 linked publications.
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 11 Sep 2026.