Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT03575338|
Recruitment Status : Unknown
Verified June 2018 by josep torrent, Hospital Mutua de Terrassa.
Recruitment status was: Recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hallux Valgus and Bunion (Disorder)||Procedure: Open Scarf Osteotomy Procedure: Minimally invasive scarf Osteotomy||Not Applicable|
Hallux valgus surgery is a common procedure being the open scarf osteotomy, one of the most studied techniques for correction of the hallux valgus. It is widely reported its capacity to reduce the angle of the first metatarso-phalangeal joint.
Minimally invasive scarf (MIS) technique has been designed to decrease the soft tissue damage and postoperative pain. This procedure does not require ischemia, being able to do under local anesthesia and sedation. This technique is more suitable for outpatient surgery.
There is a lack of studies comparing both techniques, and our purpose is to do a prospective comparative study among the two approaches of the scarf osteotomy: open vs MIS.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcomes assessor will not know the technique|
|Official Title:||Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
Active Comparator: Open Scarf Osteotomy
This group of patients will undergo surgery performing an open scarf osteotomy
Procedure: Open Scarf Osteotomy
Open Scarf Osteotomy
Experimental: Minimally invasive scarf Osteotomy
This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy
Procedure: Minimally invasive scarf Osteotomy
Minimally invasive scarf Osteotomy
- Hallux valgus angle postoperative [ Time Frame: 1 year - 2 years ]The angle among the first metatarsal and the first phalanx
- Intermetatarsal 1-2 angle [ Time Frame: 1 year - 2 years ]The angle among the 1st and the 2nd metatarsal
- First metatarso-phalangeal range of movement [ Time Frame: 1 year - 2 years ]The range of movement of the first metatarso-phalangeal joint
- Surgery duration [ Time Frame: Measurement during the surgery ]The records of the surgery duration
- Irradiation [ Time Frame: Measurement during the surgery ]The records of the radiation during the surgeries
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): NCT03575338