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

Primary Purpose

Hallux Valgus

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Reverdin-Isham Osteotomy
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring Hallux Valgus, Reverdin-Isham Osteotomy, Minimally Invasive Surgery, Percutaneous Distal Osteotomy, First Ray, Forefoot

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carlo Biz MD

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HV patients

Arm Description

patients with symptomatic Hallux Valgus treated my Reverdin-Isham Osteotomy

Outcomes

Primary Outcome Measures

clinical changes after surgical treatment
evaluation scale: AOFAS score

Secondary Outcome Measures

radiological changes after surgical treatment
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
Postoperative pain levels and incidence of Chronic Pain Syndrome (CPS)
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.

Full Information

First Posted
August 23, 2016
Last Updated
May 26, 2021
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT02886221
Brief Title
Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy
Acronym
MISHV
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
Hallux Valgus, Reverdin-Isham Osteotomy, Minimally Invasive Surgery, Percutaneous Distal Osteotomy, First Ray, Forefoot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HV patients
Arm Type
Other
Arm Description
patients with symptomatic Hallux Valgus treated my Reverdin-Isham Osteotomy
Intervention Type
Procedure
Intervention Name(s)
Reverdin-Isham Osteotomy
Intervention Description
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 Outcome Measure Information:
Title
clinical changes after surgical treatment
Description
evaluation scale: AOFAS score
Time Frame
preoperative and at 3-12-48 months post-operative
Secondary Outcome Measure Information:
Title
radiological changes after surgical treatment
Description
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
Time Frame
preoperative and at 3-12-48 months post-operative
Title
Postoperative pain levels and incidence of Chronic Pain Syndrome (CPS)
Description
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.
Time Frame
Patients were evaluated prospectively at 7 days, 1, 3 and 6 months after surgery for pain at rest and during movement.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Carlo Biz MD
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Age, Gender, Radiological parameters and images.
Citations:
PubMed Identifier
7249460
Citation
Mann RA, Coughlin MJ. Hallux valgus--etiology, anatomy, treatment and surgical considerations. Clin Orthop Relat Res. 1981 Jun;(157):31-41.
Results Reference
result
PubMed Identifier
15831256
Citation
Trnka HJ. Osteotomies for hallux valgus correction. Foot Ankle Clin. 2005 Mar;10(1):15-33. doi: 10.1016/j.fcl.2004.10.002.
Results Reference
result
PubMed Identifier
2015537
Citation
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.
Results Reference
result
PubMed Identifier
34911525
Citation
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.
Results Reference
derived
PubMed Identifier
27919259
Citation
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.
Results Reference
derived

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

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