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

Orthopedic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534724
• Other study ID #: ORL-ORT-033
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Martin Riegger, MD
• Phone: 0041918117029
• Email: RicercaOrtopedia.ORL[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hallux Valgus
• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

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

Locations

Country	Name	City	State
Switzerland	EOC	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Ente Ospedaliero Cantonale, Bellinzona

Country where clinical trial is conducted

Switzerland, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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): — View Citation

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):e0 — View Citation

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 201 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	At the day of surgery, at 6, 12 and 24 weeks postoperatively.
Secondary	Bone consolidation through anteroposterior and lateral foot x-rays	Incidence of bone consolidation (bone callus formation) assessed in an objective measure by the radiologist	6 weeks and 12 weeks. At 24 weeks in case of fracture non-union reported at the 12th week postoperatively
Secondary	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.	at 6, 12 and 24 weeks
Secondary	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.	at 12 and 24 weeks

External Links

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