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Trial record 2 of 48 for:    SERI

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

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 13, 2018
Last Update Posted Date September 17, 2018
Actual Study Start Date  ICMJE March 10, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outcomes of Hallux Valgus Correction Surgery
Official Title  ICMJE Radiological Measurements in Patients With Mild to Severe Hallux Valgus After Correction Surgery (SERI)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hallux Valgus
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Procedure: a minimally invasive surgery (SERI)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2018)
29
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 25, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03669900
Other Study ID Numbers  ICMJE Hallux Valgus and SERI
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raheef Alatassi, Security Forces Hospital
Study Sponsor  ICMJE Security Forces Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Talal Almalki, FRCS Security Forces Hospital
PRS Account Security Forces Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP