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randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions
The objective of this prospective, randomized controlled trial is to determine if there are any adverse outcomes associated with immediate weight bearing as compared to non-weight bearing following first MTP joint fusion. The primary outcome measures will look at patient reported outcomes of pain and function. The secondary outcome measures will be the difference in the incidence of non-union, as well as adverse events/complications (malunion, wound complications, hardware complications, infection, stress fracture).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weightbearing | Active Comparator | Immediate weightbearing after surgery |
|
| Non weightbearing | Active Comparator | nonweightbearing x 6 weeks post surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| weightbearing | Other | immediate weightbearing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Foot and Ankle Ability Measure (FAAM) | Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function | pre op |
| Foot and Ankle Ability Measure (FAAM) | Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function | 6 months |
| Visual analogue scale(VAS) | patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain | pre op |
| Visual analogue scale(VAS) | patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic healing | Union is defined as new bone formation across the cortex of the fusion site | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Francis, RN | Contact | 9022250199 | francisp@nshealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mark Glazebrook, MD FRCS | NSHA\ Dalhousie UNiversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health Authority | Recruiting | Halifax | Nova Scotia | B3h1V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26320560 | Background | Rammelt S, Panzner I, Mittlmeier T. Metatarsophalangeal Joint Fusion: Why and How? Foot Ankle Clin. 2015 Sep;20(3):465-77. doi: 10.1016/j.fcl.2015.04.008. Epub 2015 Jun 10. | |
| 24878413 | Background | Wood EV, Walker CR, Hennessy MS. First metatarsophalangeal arthrodesis for hallux valgus. Foot Ankle Clin. 2014 Jun;19(2):245-58. doi: 10.1016/j.fcl.2014.02.006. Epub 2014 Mar 21. |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| D020859 | Hallux Rigidus |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D005531 | Foot Deformities, Acquired |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D016474 | Weight-Bearing |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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| 24685193 | Background | Little JB. First metatarsophalangeal joint arthrodesis in the treatment of hallux valgus. Clin Podiatr Med Surg. 2014 Apr;31(2):281-9. doi: 10.1016/j.cpm.2013.12.009. Epub 2014 Feb 26. |