- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02886221
Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy (MISHV)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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PD
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Padova, PD, Italy, 35128
- Carlo Biz MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: HV patients
patients with symptomatic Hallux Valgus treated my Reverdin-Isham Osteotomy
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical changes after surgical treatment
Time Frame: preoperative and at 3-12-48 months post-operative
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evaluation scale: AOFAS score
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preoperative and at 3-12-48 months post-operative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
radiological changes after surgical treatment
Time Frame: preoperative and at 3-12-48 months post-operative
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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
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preoperative and at 3-12-48 months post-operative
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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.
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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.
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Patients were evaluated prospectively at 7 days, 1, 3 and 6 months after surgery for pain at rest and during movement.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Mann RA, Coughlin MJ. Hallux valgus--etiology, anatomy, treatment and surgical considerations. Clin Orthop Relat Res. 1981 Jun;(157):31-41.
- Trnka HJ. Osteotomies for hallux valgus correction. Foot Ankle Clin. 2005 Mar;10(1):15-33. doi: 10.1016/j.fcl.2004.10.002.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIS01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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