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Recruiting NCT05534724

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

No phase Interventional Hallux Valgus Orthopedic Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Partial weight-bearing (10 - 15kg), Complete weight-bearing.
Who it may be relevant to
Registry conditions: Hallux Valgus, Orthopedic Disorder. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Is Full Weight Bearing After the Modified Lapidus Operation Possible? A Randomized Controlled Trial to Compare Early and Partial Weight-bearing

Overview

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).

Interventions

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

Primary outcome measures

  • Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS) [Time frame: at 6 weeks]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • EOC — Lugano

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. PMID 6437370
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT05534724 · ORL-ORT-033

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗