Hallux ValgusMISHVNCT02886221
Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy
A study of Hallux Valgus, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hallux Valgus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- May 2010to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild to severe symptomatic hallux valgus
Who cannot join
- congenital deformities of the foot
- hallux rigidus
- previous first ray trauma or foot and ankle surgery
- rheumatic, dismetabolic, neurologic, infective, or psychiatric pathologies.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Reverdin-Isham Osteotomy
- Keywords
- Hallux Valgus, Reverdin-Isham Osteotomy, Minimally Invasive Surgery, Percutaneous Distal Osteotomy, First Ray, Forefoot
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverdin-Isham OsteotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| HV patients | Other | patients with symptomatic Hallux Valgus treated my Reverdin-Isham Osteotomy Receives: Procedure: Reverdin-Isham Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical changes after surgical treatment
evaluation scale: AOFAS score
Measured: preoperative and at 3-12-48 months post-operative
Secondary outcomes (2)
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
Measured: preoperative and at 3-12-48 months post-operative
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.
Measured: Patients were evaluated prospectively at 7 days, 1, 3 and 6 months after surgery for pain at rest and during movement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startMay 2010
- Primary completionJun 2020
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Biz, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886221
- Sponsor's protocol ID
- MIS01
- Acronym
- MISHV
- Status last verified
- May 2021
- First submitted
- 23 Aug 2016
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Age, Gender, Radiological parameters and images.
Publications
Mann RA, Coughlin MJ. Hallux valgus--etiology, anatomy, treatment and surgical considerations. Clin Orthop Relat Res. 1981 Jun;(157):31-41.
PubMed 7249460Trnka HJ. Osteotomies for hallux valgus correction. Foot Ankle Clin. 2005 Mar;10(1):15-33. doi: 10.1016/j.fcl.2004.10.002.
PubMed 15831256Isham 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.
PubMed 2015537Biz 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.
PubMed 34911525Biz 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.
PubMed 27919259
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02886221
- Acronym / sponsor ID
- MISHV / MIS01
- Conditions
- Hallux Valgus
- Keywords
- Hallux Valgus, Reverdin-Isham Osteotomy, Minimally Invasive Surgery, Percutaneous Distal Osteotomy, First Ray, Forefoot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HV patients | Other | Procedure: Reverdin-Isham Osteotomypatients with symptomatic Hallux Valgus treated my Reverdin-Isham Osteotomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mild to severe symptomatic hallux valgus
Key exclusion criteria (4 listed)
- congenital deformities of the foot
- hallux rigidus
- previous first ray trauma or foot and ankle surgery
- rheumatic, dismetabolic, neurologic, infective, or psychiatric pathologies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reverdin-Isham OsteotomyIncision 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. | Procedure or surgery | HV patients |
Primary outcome
clinical changes after surgical treatment
Time frame: preoperative and at 3-12-48 months post-operative
evaluation scale: AOFAS score
2 secondary outcomes
radiological changes after surgical treatment
Time frame: preoperative and at 3-12-48 months post-operative
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Results publication: PubMed 7249460Mann RA, Coughlin MJ. Hallux valgus--etiology, anatomy, treatment and surgical considerations. Clin Orthop Relat Res. 1981 Jun;(157):31-41.
- Results publication: PubMed 15831256Trnka HJ. Osteotomies for hallux valgus correction. Foot Ankle Clin. 2005 Mar;10(1):15-33. doi: 10.1016/j.fcl.2004.10.002.
- Results publication: PubMed 2015537Isham 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.
- Derived from this study: PubMed 34911525Biz 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.
- Derived from this study: PubMed 27919259Biz 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.
- Individual participant dataSharing planned: Yes. Age, Gender, Radiological parameters and images.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hallux Valgus, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical changes after surgical treatment (time frame: preoperative and at 3-12-48 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02886221, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.