Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy

NCT02886221 | Completed

• 1 other identifier: MIS01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Minimally invasive surgery (MIS) represents one of the most innovative surgical treatments of Hallux Valgus (HV). However, long-term outcomes still remain a matter of discussion within the orthopaedic community. The purpose of this longitudinal prospective study was to evaluate radiographic and functional outcomes in patients with mild-to-severe HV who underwent Reverdin-Isham and Akin percutaneous osteotomy, following exostosectomy and lateral release.

Conditions

Hallux Valgus

Keywords

Hallux Valgus; Reverdin-Isham Osteotomy; Minimally Invasive Surgery; Percutaneous Distal Osteotomy; First Ray; Forefoot

Outcome Measures

Primary Outcomes (1)

• clinical changes after surgical treatment

  evaluation scale: AOFAS score

  preoperative and at 3-12-48 months post-operative

Secondary Outcomes (2)

• radiological changes after surgical treatment

  preoperative and at 3-12-48 months post-operative

• Postoperative pain levels and incidence of Chronic Pain Syndrome (CPS)

  Patients were evaluated prospectively at 7 days, 1, 3 and 6 months after surgery for pain at rest and during movement.

Study Arms (1)

HV patients

OTHER

patients with symptomatic Hallux Valgus treated my Reverdin-Isham Osteotomy

Procedure: Reverdin-Isham Osteotomy

Interventions

Reverdin-Isham Osteotomy PROCEDURE

Incision on the medial part of the foot, a Shannon Isham burr was introduced at the junction of metaphysis and epiphysis. It was applied to the flat bone surface achieved previously at approximately 45°, keeping the articular cartilage surface of the first metatarsal head as reference point on the superior cortex. In this position, under fluoroscopic control, the osteotomy was started following a distal-dorsal and proximal-plantar direction. At this point, the burr was slightly withdrawn in order to preserve a few millimetres of the lateral cortex, and the osteotomy of the plantar cortex was performed completely. Then, a Wedge burr was used to create a wedge with a medially oriented base. At the point of closing the wedge, osteoclasis of the preserved lateral cortex was achieved, modifying the orientation of the articular surface, normalizing the DMAA value, and adding an intrinsic stability to the osteotomy by producing contact of the trabecular bone.

HV patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mild to severe symptomatic hallux valgus

You may not qualify if:

• congenital deformities of the foot
• hallux rigidus
• previous first ray trauma or foot and ankle surgery
• rheumatic, dismetabolic, neurologic, infective, or psychiatric pathologies.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Carlo Biz MD

Padua, PD, 35128, Italy

Location

Related Publications (5)

• Mann RA, Coughlin MJ. Hallux valgus--etiology, anatomy, treatment and surgical considerations. Clin Orthop Relat Res. 1981 Jun;(157):31-41.

  PMID: 7249460 RESULT

• Trnka HJ. Osteotomies for hallux valgus correction. Foot Ankle Clin. 2005 Mar;10(1):15-33. doi: 10.1016/j.fcl.2004.10.002.

  PMID: 15831256 RESULT

• Isham SA. The Reverdin-Isham procedure for the correction of hallux abducto valgus. A distal metatarsal osteotomy procedure. Clin Podiatr Med Surg. 1991 Jan;8(1):81-94.

  PMID: 2015537 RESULT

• Biz C, de Iudicibus G, Belluzzi E, Dalmau-Pastor M, Bragazzi NL, Funes M, Parise GM, Ruggieri P. Prevalence of chronic pain syndrome in patients who have undergone hallux valgus percutaneous surgery: a comparison of sciatic-femoral and ankle regional ultrasound-guided nerve blocks. BMC Musculoskelet Disord. 2021 Dec 15;22(1):1043. doi: 10.1186/s12891-021-04911-4.

  PMID: 34911525 DERIVED

• Biz C, Fosser M, Dalmau-Pastor M, Corradin M, Roda MG, Aldegheri R, Ruggieri P. Functional and radiographic outcomes of hallux valgus correction by mini-invasive surgery with Reverdin-Isham and Akin percutaneous osteotomies: a longitudinal prospective study with a 48-month follow-up. J Orthop Surg Res. 2016 Dec 5;11(1):157. doi: 10.1186/s13018-016-0491-x.

  PMID: 27919259 DERIVED

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 1, 2016
• Study Start: May 1, 2010
• Primary Completion: June 1, 2020
• Study Completion: March 1, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)