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Outcomes of Hallux Valgus Correction Surgery

Primary Purpose

Hallux Valgus

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
a minimally invasive surgery (SERI)
Sponsored by
Security Forces Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring SERI, correction surgery, Complications, radiological, outcomes

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All adult patients aged 20 years old to 60 years old admitted and managed for hallux valgus during the last 3 years (2013 - 2016) at Security Forces Hospital, Riyadh, Saudi Arabia.
  • Reducible mild or moderate HV, HVA of ≤40o, IMA ≤20o with some severe cases.
  • Patient with arthritis of the 1st MTP joint up to grade 2 according to the Regnauld's classification
  • At least 2 years of follow-up in the hospital.

Exclusion Criteria:

  • Patients who have stiffness of the first MTP joint
  • Patients with severe arthritis of the first MTP joint (more than Regnauld's grade 2)
  • Patients with history of rheumatoid arthritis or other inflammatory diseases, diabetics.
  • Patients with neurological disorders.
  • Patients with prior hallux surgery.

Sites / Locations

  • Security Forces Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

a minimally invasive surgery (SERI)

Arm Description

The surgery consisted of varus traction, skin incision, metatarsal osteotomy and K- wire insertion. All the cases were done by the senior consultant orthopedic surgeon, including preoperative planning, the osteotomy itself and the follow up in the clinic. Another orthopedic surgeon was involved in collecting the data, doing all the measurements preoperative and postoperative and assisting the primary surgeon during the surgery.

Outcomes

Primary Outcome Measures

radiological measurements
Radiological assessment includes weight-bearing anteroposterior (AP) and lateral imaging of the foot. The severity of the deformity is usually classified as mild, when the hallux valgus angle (HVA) is up to 19o , intermetatarsal angle (IMA) up to 13o; moderate when HVA is 20o to 40o; and severe when HVA is >40o and IMA >20o

Secondary Outcome Measures

Full Information

First Posted
September 12, 2018
Last Updated
September 13, 2018
Sponsor
Security Forces Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03669900
Brief Title
Outcomes of Hallux Valgus Correction Surgery
Official Title
Radiological Measurements in Patients With Mild to Severe Hallux Valgus After Correction Surgery (SERI)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 10, 2018 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
August 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Security Forces Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
HV correction surgery using SERI appear to sufficiently reduce the severity of HV deformity in all radiological measurements (HVA, IMA, DMAA) and the correction of subluxation of the first MTP joint and the sesamoids. SERI technique is an easy, inexpensive, less invasive, more cosmetic, with shorter operative time and with minimal complication rates. To our knowledge, there is no report regarding HV treatment using SERI from Saudi Arabia or in any part of the Middle East. Therefore, this study conducted to determine the radiological measurements done preoperatively and compare the measurements done at one year postoperatively, recording the complication happened and measuring the cost effectiveness of such procedure.
Detailed Description
Hallux valgus (HV) is defined as a complex deformity where there is a lateral deviation of the proximal phalanx on the first metatarsal head (hallux) that is frequently associated with medial deviation of the first metatarsal, which may sometimes be accompanied by a significant functional disability and foot pain. Worldwide estimates from reports show a prevalence of 23% among adults below 65 years old and 35.7% among adults >65 years old, higher among females, and directly proportional to increasing age. Because of the concomitant pain and other functional disability with HV, surgery is indicated usually depending on the degree of deformity based on the radiological findings as well as the physical examination findings. Radiological assessment includes weight-bearing anteroposterior (AP) and lateral imaging of the foot. The severity of the deformity is usually classified as mild, when the hallux valgus angle (HVA) is up to 19o , intermetatarsal angle (IMA) up to 13o; moderate when HVA is 20o to 40o; and severe when HVA is >40o and IMA >20o. There were a multitude of modern concepts in the surgical treatment of HV, including the Keller's procedure, the distal soft-tissue procedure, osteotomies of the first metatarsal, distal metatarsal osteotomies (Wilson procedure, Mitchell osteotomy, distal Chevron osteotomy), and many other type of surgeries including diaphyseal osteotomies and arthrodesis. Most of these surgical procedures were shown to provide morphologic and functional re-balance after surgery. While there are more than 150 surgical procedures described to treat HV, none of them is considered as a gold standard and each one had it is own advantages and disadvantages. Minimally invasive techniques for correction of HV include arthroscopy, percutaneous and minimum incision surgery which were found to provide better outcome by decreasing recovery and rehabilitation time. On the other hand, some authors suggested that to correct HV deformity using SERI, a lateral soft tissue release should be performed first and reposition the sesamoids to avoid recurrence of the HV. The SERI technique (as abbreviated to stand for simple, effective, rapid and inexpensive) was presented by several authors to be a minimally invasive technique since it presents with the same advantages as the percutaneous techniques with less tissue dissection and a need for only temporary hardware, meaning no instrumentation and surgery is performed under direct vision without fluoroscopy. It is a type of distal first metatarsal osteotomy. Several studies using SERI have shown adequate correction of the deformity without avascular necrosis of the metatarsal head, pseudoarthrosis or recurrence. Radiographic assessment including angular radiological parameters, sesamoid subluxation, and the articular congruency were shown to prove adequate correction of angular HV deformities. Preoperatively, measuring the axial view of the sesamoid position in the radiographic assessment of HV was proven to guide the surgeon on the appropriate surgical technique. Furthermore, measurements of the HVA and the IMA were recommended to evaluate preoperative assessment of the severity of HV and postoperative outcome of surgical treatment of HV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
SERI, correction surgery, Complications, radiological, outcomes

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
a minimally invasive surgery (SERI)
Arm Type
Other
Arm Description
The surgery consisted of varus traction, skin incision, metatarsal osteotomy and K- wire insertion. All the cases were done by the senior consultant orthopedic surgeon, including preoperative planning, the osteotomy itself and the follow up in the clinic. Another orthopedic surgeon was involved in collecting the data, doing all the measurements preoperative and postoperative and assisting the primary surgeon during the surgery.
Intervention Type
Procedure
Intervention Name(s)
a minimally invasive surgery (SERI)
Intervention Description
The SERI technique (as abbreviated to stand for simple, effective, rapid and inexpensive) was presented by several authors to be a minimally invasive technique since it presents with the same advantages as the percutaneous techniques with less tissue dissection and a need for only temporary hardware, meaning no instrumentation and surgery is performed under direct vision without fluoroscopy
Primary Outcome Measure Information:
Title
radiological measurements
Description
Radiological assessment includes weight-bearing anteroposterior (AP) and lateral imaging of the foot. The severity of the deformity is usually classified as mild, when the hallux valgus angle (HVA) is up to 19o , intermetatarsal angle (IMA) up to 13o; moderate when HVA is 20o to 40o; and severe when HVA is >40o and IMA >20o
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adult patients aged 20 years old to 60 years old admitted and managed for hallux valgus during the last 3 years (2013 - 2016) at Security Forces Hospital, Riyadh, Saudi Arabia. Reducible mild or moderate HV, HVA of ≤40o, IMA ≤20o with some severe cases. Patient with arthritis of the 1st MTP joint up to grade 2 according to the Regnauld's classification At least 2 years of follow-up in the hospital. Exclusion Criteria: Patients who have stiffness of the first MTP joint Patients with severe arthritis of the first MTP joint (more than Regnauld's grade 2) Patients with history of rheumatoid arthritis or other inflammatory diseases, diabetics. Patients with neurological disorders. Patients with prior hallux surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talal Almalki, FRCS
Organizational Affiliation
Security Forces Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Security Forces Hospital
City
Riyadh
ZIP/Postal Code
12625
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
20868524
Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Outcomes of Hallux Valgus Correction Surgery

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