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

NCT ID: NCT02886221

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2021-03-31

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.

Detailed Description

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.

Conditions

Hallux Valgus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HV patients

patients with symptomatic Hallux Valgus treated my Reverdin-Isham Osteotomy

Group Type: OTHER

Reverdin-Isham Osteotomy

Intervention Type: 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.

Interventions

Reverdin-Isham Osteotomy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Carlo Biz

MD, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Carlo Biz MD

Padua, PD, Italy

Countries

Italy

References

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

Reference Type: RESULT

PMID: 7249460 (View on PubMed)

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

Reference Type: RESULT

PMID: 15831256 (View on PubMed)

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.

Reference Type: RESULT

PMID: 2015537 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34911525 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27919259 (View on PubMed)

Other Identifiers

MIS01

Identifier Type: -

Identifier Source: org_study_id