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Outcomes of Hallux Valgus Correction Surgery

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ClinicalTrials.gov Identifier: NCT03669900
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Raheef Alatassi, Security Forces Hospital

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.


Condition or disease Intervention/treatment Phase
Hallux Valgus Procedure: a minimally invasive surgery (SERI) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiological Measurements in Patients With Mild to Severe Hallux Valgus After Correction Surgery (SERI)
Actual Study Start Date : March 10, 2018
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : August 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion

Arm Intervention/treatment
a minimally invasive surgery (SERI)
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.
Procedure: a minimally invasive surgery (SERI)
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 Measures :
  1. radiological measurements [ Time Frame: one year ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669900


Locations
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Saudi Arabia
Security Forces Hospital
Riyadh, Saudi Arabia, 12625
Sponsors and Collaborators
Security Forces Hospital
Investigators
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Study Director: Talal Almalki, FRCS Security Forces Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Raheef Alatassi, Orthopedic Surgeon, Security Forces Hospital
ClinicalTrials.gov Identifier: NCT03669900    
Other Study ID Numbers: Hallux Valgus and SERI
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raheef Alatassi, Security Forces Hospital:
SERI
correction surgery
Complications
radiological
outcomes
Additional relevant MeSH terms:
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Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired