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'Evaluatie van MTP-1 artrodese en (hemi)prothese als behandeling van MTP-1 artrose met behulp van gangbeeld analyse'


- candidate number28080
- NTR NumberNTR6770
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-okt-2017
- Secondary IDsMETC 14-4-080 17-N-14
- Public Title'Evaluatie van MTP-1 artrodese en (hemi)prothese als behandeling van MTP-1 artrose met behulp van gangbeeld analyse'
- Scientific TitleClinical and Quantitative Gait Analysis in Patients with Hallux Rigidus treated with MTP-1 arthrodesis, hemiprosthesis or prosthesis.
- ACRONYM
- hypothesisWe hypothesize that the range of motion of the hallux is limited during gait in patients with hallux rigidus (HR). In addition, we hypothesize that patients with HR will compensate this loss of motion of the hallux by increasing joint motion in the forefoot and hindfoot, in order to facilitate movement. Concerning plantar pressure, we expect a decreased pressure beneath the hallux with increased plantar pressure beneath the lesser metatarsals due to pain.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Hallux rigidus, Metatarsophalangeal joint
- Inclusion criteria- Degenerative Hallux Rigidus, radiologically confirmed
- Failed conservative traject
- Able to walk more than 100 meters barefoot
- Exclusion criteria- Diabetes Mellitus
- Reumatoid Arthritis
- Gout
- Total Knee Prosthesis
- Total Hip Prosthesis
- Arthrodesis of another joint in the foot of interest
- Neurological condition resulting in an altered gait pattern
- Fractur(s) of bone(s) in the lower extremities resulting in an altered gait pattern
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-jan-2015
- planned closingdate1-jan-2019
- Target number of participants45
- Interventions- MTP1 arthrodesis
- MTP1 hemiprosthesis
- MTP1 prosthesis
- Primary outcomeRange of Motion (ROM) of the hallux-forefoot segment, forefoot-hindfoot segment and hindfoot-tibia segment
- Secondary outcome- Spatiotemporal parameters (gait velocity, stride length, stride width, step length, step time, cadence, stance time)
- Plantar Pressure (Peak Pressure & Pressure Time Integral)
- Clinical Functioning/Outcome (AOFAS-HMI, VAS-pain, MOXFQ, FFI, SF-36)
- TimepointsT1= prior to surgery
T2= one year after surgery
- Trial web siten.a.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Jasper Stevens
- CONTACT for SCIENTIFIC QUERIESDrs. Jasper Stevens
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryDespite the extensive literature on the surgical treatment of HR, no studies compared arthrodesis, hemiprosthesis and prosthesis as treatment options from an biomechanical point of view. The goal of this study is to find some clues in the gait pattern of patients with HR, which can help us in the future to predict which treatment option results in the best patient reported outcome in a patient-specific manner.
- Main changes (audit trail)
- RECORD24-okt-2017 - 5-nov-2017


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