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NCT Number: NCT02886221

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

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.

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carlo Biz MD

Padova, PD, 35128, Italy

About this study

One hundred and eighty patients with mild-to-severe symptomatic HV were treated by MIS. Clinical evaluation was assessed pre-operatively, as well as at 3 and 12 months after surgery and at final follow-up of 48 months, using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux grading system. Patient satisfaction and complications were recorded.Further parameters assessed were postoperative pain at rest and during movement by the numerical rating scale (NRS), patient satisfaction using the Visual Analogue Scale (VAS), quality of life, and return to daily activities. Incidence of Chronic Pain Syndrome (CPS), Type of anesthesia and ASA were evaluated and recorded.

Computer-assisted measurement of antero-posterior radiographs was taken pre-operatively, as well as at 3 and 12 months after surgery and at 48-month follow-up, analysing the intermetatarsal angle (IMA), the hallux valgus angle (HVA), the distal metatarsal articular angle (DMAA), and the tibial sesamoid position. Also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency and the metatarsal index were calculated only preoperatively and at last follow-up. Statistical analysis was carried out using the paired t-test. Statistical significance was set at p < 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with mild to severe symptomatic hallux valgus

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. clinical changes after surgical treatment

    Time frame: preoperative and at 3-12-48 months post-operative

    evaluation scale: AOFAS score

Secondary outcomes

  1. radiological changes after surgical treatment

    Time frame: preoperative and at 3-12-48 months post-operative

    evaluation of the Intermetatarsal angle(IMA) of the first ray, distal metatarsal articular angle of the first metatarsal (DMAA), hallux valgus angle (HVA) and tibial sesamoid position

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

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

    The parameters assessed were postoperative pain at rest and during movement by the numerical rating scale (NRS), patient satisfaction using the Visual Analogue Scale (VAS), quality of life, and return to daily activities.

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy: a Longitudinal Prospective Study With a 48-month Follow-up

Acronym: MISHV

Important dates

Study start
2010
Primary completion
2020
Study completion
2021
First posted
Sep 1, 2016
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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