Hallux Valgus
Conditions
Keywords
Lapidus Arthrodesis, Early Weight Bearing, First Tarsometatarsal Arthrodesis
Brief summary
A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight Bearing Following Modified Lapidus Arthrodesis
Detailed description
The purpose of this prospective randomized control trial is to assess outcomes in patients who undergo modified Lapidus arthrodesis and whose postoperative management includes early weight bearing on heel (in a boot) and compare it to standard of care non weight bearing post operative management.
Interventions
OTHER(EWB) Early Weight Bearing (2 Weeks Post-op)
Patient were permitted to progressively weightbear on their heel at 2 week post-op.
Sponsors
Grand Rapids Medical Education Partners
Orthopaedic Associates of Michigan, PC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients were blinded to treatment until their 2 week post-operative visit.
Intervention model description
Prospective, Randomized, Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient has signed the Institutional Review Board approved informed consent form specific to this study prior to enrollment * Failure of conservative treatment (i.e. non-surgical action, consisting of footwear modification in the form of shoes with wide toe boxes, padded inserts, activity modifications and pain control medications) * Patients who underwent Lapidus procedure with or without other procedures of the first ray (i.e., muscle-tendon procedures, distal metatarsal osteotomy, Akin procedure) * Patient older than 18 years of age * Patient is able to give informed consent * Patient is independent, ambulatory, and agrees to comply with all postoperative visits
Exclusion criteria
* Patient has a pre-existing condition which may cause impairment of healing and bone fusion * Any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study * Patients who underwent Lapidus arthrodesis in conjunction with other procedures that did not focus on the first pedal ray with the exception of harvesting autogenous ipsilateral calcaneal bone graft
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TMT Fusion Rate | 6 months | To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | 12 months | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: \[0 (no pain) - 10 (worse possible pain)\] |
| American Foot & Ankle Society Midfoot Scores (AOFAS) | 12 months | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period.\] AOFAS Scale: \[0 (no function/severe deformity) to 83 (full function/no limitations/deformity)\] |
| Short Musculoskeletal Function Assessment (SMFA) | 12 months | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SMFA Scale: 101 items scored 1 to 5 \[1( problems/no difficulty/not bothered) - 5 (unable to do task/symptoms constantly/extremely bothered)\] |
| Foot Function Index Revised (FFIr) | 12 months | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. FFIr Scale: 67 items scored 1 to 7 \[1(no problems/no difficulty/not bothered) - 6 (unable to do a task/symptoms all the time/worst pain imaginable) - 7 (Not applicable)\]. Score range: 46 to 230. |
| Short Form Health Survey (SF-36) v.2 | 12 months | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SF-36 v.2 Scale: Self-reporting outcomes assessment \[0 (no function/severe physical/mental disability) to 100 (full function, no limitations to mental/physical health)\]. Score range: 46 to 230. |
Countries
United States
Outcome results
None listed