A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery

NCT05534724 | Recruiting

• 1 other identifier: ORL-ORT-033
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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 as a novel approach for rehabilitation after a foot surgery.

Conditions

Hallux Valgus; Orthopedic Disorder

Keywords

Quality of life; Bone consolidation; Foot surgery; Lapidus surgery; Weil surgery; Hohmann surgery; Akin surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  at 6 weeks

Secondary Outcomes (4)

• Pain on a Visual Analogue Scale

  At the day of surgery, at 6, 12 and 24 weeks postoperatively.

• Bone consolidation through anteroposterior and lateral foot x-rays

  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

  at 6, 12 and 24 weeks

• Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)

  at 12 and 24 weeks

Study Arms (2)

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

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

Other: Complete weight-bearing

Interventions

Partial weight-bearing (10 - 15kg) OTHER

Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks

Partial weight-bearing (10 - 15kg)

Complete weight-bearing OTHER

Complete post-operative weight-bearing with a VACOPASO shoe for 6 weeks

Complete weight-bearing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

EOC

Lugano, 6900, Switzerland

RECRUITING

Related Publications (20)

• 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.

  PMID: 6437370 BACKGROUND

• LAPIDUS 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.

  PMID: 13413410 BACKGROUND

• Butson 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.

  PMID: 6997319 BACKGROUND

• Kitaoka 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.

  PMID: 7951968 RESULT

• Drummond 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.

  PMID: 29472168 RESULT

• Ray 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.

  PMID: 9798168 RESULT

• Sangeorzan BJ, Hansen ST Jr. Modified Lapidus procedure for hallux valgus. Foot Ankle. 1989 Jun;9(6):262-6. doi: 10.1177/107110078900900602.

  PMID: 2744666 RESULT

• Myerson 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.

  PMID: 1601337 RESULT

• Bednarz 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.

  PMID: 11128011 RESULT

• Saxena 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.

  PMID: 19232969 RESULT

• Blitz 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.

  PMID: 20610203 RESULT

• Kopp 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.

  PMID: 16309603 RESULT

• Catanzariti 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.

  PMID: 10553545 RESULT

• Myerson MS, Badekas A. Hypermobility of the first ray. Foot Ankle Clin. 2000 Sep;5(3):469-84.

  PMID: 11232392 RESULT

• Delgado 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.

  PMID: 30211382 RESULT

• Arnold H. [The Akin procedure as closing wedge osteotomy for the correction of a hallux valgus interphalangeus deformity]. Oper Orthop Traumatol. 2008 Dec;20(6):477-83. doi: 10.1007/s00064-008-1503-8. German.

  PMID: 19137394 RESULT

• Podskubka A, Stedry V, Kafunek M. [Distal shortening osteotomy of the metatarsals using the Weil technique: surgical treatment of metatarsalgia and dislocation of the metatarsophalangeal joint]. Acta Chir Orthop Traumatol Cech. 2002;69(2):79-84. Czech.

  PMID: 12073646 RESULT

• Christensen PH, Hansen TB. Hallux valgus correction using a modified Hohmann technique. Foot Ankle Int. 1995 Apr;16(4):177-80. doi: 10.1177/107110079501600401.

  PMID: 7787972 RESULT

• Nix S, Smith M, Vicenzino B. Prevalence of hallux valgus in the general population: a systematic review and meta-analysis. J Foot Ankle Res. 2010 Sep 27;3:21. doi: 10.1186/1757-1146-3-21.

  PMID: 20868524 RESULT

• Deal JB Jr, Patzkowski JC, Groth AT, Ryan PM, Dowd TC, Osborn PM, Anderson CD, Ficke JR, Kirk KL. Early vs Delayed Weightbearing After Microfracture of Osteochondral Lesions of the Talus: A Prospective Randomized Trial. Foot Ankle Orthop. 2019 May 6;4(2):2473011419838832. doi: 10.1177/2473011419838832. eCollection 2019 Apr.

  PMID: 35097322 RESULT

Related Links

• VACOpaso Free OPED

MeSH Terms

Conditions

Hallux Valgus; Musculoskeletal Diseases

Interventions

Partial Weight-Bearing

Condition Hierarchy (Ancestors)

Foot Deformities

Intervention Hierarchy (Ancestors)

Weight-Bearing; Mechanical Phenomena; Physical Phenomena

Study Officials

• Martin Riegger, MD

  EOC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Riegger, MD

CONTACT

0041918117029; RicercaOrtopedia.ORL@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: January 19, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

CH (1)