Back to resultsEarly Weight Bearing Tarsometatarsal Fusion Study
Primary Purpose
Hallux Valgus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
(EWB) Early Weight Bearing (2 Weeks Post-op)
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus focused on measuring Lapidus Arthrodesis, Early Weight Bearing, First Tarsometatarsal Arthrodesis
Eligibility Criteria
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
Sites / Locations
- Orthopaedic Associates of Michigan, PC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
(EWB) Early Weight Bearing (2 Weeks Post-op)
(SOC) Standard of Care Weight Bearing (6-8 Weeks Post-op)
Arm Description
Subjects in the EWB group were allowed to begin bearing 50 pounds (lbs) through their hindfoot in either the boot or the short leg cast at the two-week visit. They were allowed to advance their weightbearing as tolerated by 25 lbs every four days until full weightbearing through the hindfoot was achieved.
Subjects in the SOC group were allowed to heel touch weightbear for balance only on the operative foot until the six to eight week visit. At this visit all subjects were placed into a short leg walking boot. Non-weightbearing patients were permitted to begin the progressive weightbearing protocol, without hindfoot restriction.
Outcomes
Primary Outcome Measures
TMT Fusion Rate
To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation.
Secondary Outcome Measures
American Foot & Ankle Society Midfoot Scores (AOFAS)
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)
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)]
Visual Analogue Scale (VAS)
Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)]
Foot Function Index Revised (FFIr)
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
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.
Full Information
NCT ID
NCT03812237
First Posted
January 18, 2019
Last Updated
January 29, 2019
Sponsor
Orthopaedic Associates of Michigan, PC
Collaborators
Grand Rapids Medical Education Partners
1. Study Identification
Unique Protocol Identification Number
NCT03812237
Brief Title
Early Weight Bearing Tarsometatarsal Fusion Study
Official Title
A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing Versus Non-Weight Bearing Following Modified Lapidus Arthrodesis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 20, 2012 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orthopaedic Associates of Michigan, PC
Collaborators
Grand Rapids Medical Education Partners
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
Lapidus Arthrodesis, Early Weight Bearing, First Tarsometatarsal Arthrodesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized, Controlled Trial
Masking
None (Open Label)
Masking Description
Patients were blinded to treatment until their 2 week post-operative visit.
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(EWB) Early Weight Bearing (2 Weeks Post-op)
Arm Type
Experimental
Arm Description
Subjects in the EWB group were allowed to begin bearing 50 pounds (lbs) through their hindfoot in either the boot or the short leg cast at the two-week visit. They were allowed to advance their weightbearing as tolerated by 25 lbs every four days until full weightbearing through the hindfoot was achieved.
Arm Title
(SOC) Standard of Care Weight Bearing (6-8 Weeks Post-op)
Arm Type
No Intervention
Arm Description
Subjects in the SOC group were allowed to heel touch weightbear for balance only on the operative foot until the six to eight week visit. At this visit all subjects were placed into a short leg walking boot. Non-weightbearing patients were permitted to begin the progressive weightbearing protocol, without hindfoot restriction.
Intervention Type
Other
Intervention Name(s)
(EWB) Early Weight Bearing (2 Weeks Post-op)
Other Intervention Name(s)
EWB
Intervention Description
Patient were permitted to progressively weightbear on their heel at 2 week post-op.
Primary Outcome Measure Information:
Title
TMT Fusion Rate
Description
To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
American Foot & Ankle Society Midfoot Scores (AOFAS)
Description
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)]
Time Frame
12 months
Title
Short Musculoskeletal Function Assessment (SMFA)
Description
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)]
Time Frame
12 months
Title
Visual Analogue Scale (VAS)
Description
Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)]
Time Frame
12 months
Title
Foot Function Index Revised (FFIr)
Description
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.
Time Frame
12 months
Title
Short Form Health Survey (SF-36) v.2
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Orthopaedic Associates of Michigan, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11128011
Citation
Bednarz PA, Manoli A 2nd. Modified lapidus procedure for the treatment of hypermobile hallux valgus. Foot Ankle Int. 2000 Oct;21(10):816-21. doi: 10.1177/107110070002101004.
Results Reference
background
PubMed Identifier
2825872
Citation
Clark HR, Veith RG, Hansen ST Jr. Adolescent bunions treated by the modified Lapidus procedure. Bull Hosp Jt Dis Orthop Inst. 1987 Fall;47(2):109-22.
Results Reference
background
PubMed Identifier
19232969
Citation
Saxena A, Nguyen A, Nelsen E. Lapidus bunionectomy: Early evaluation of crossed lag screws versus locking plate with plantar lag screw. J Foot Ankle Surg. 2009 Mar-Apr;48(2):170-9. doi: 10.1053/j.jfas.2008.12.009.
Results Reference
background
PubMed Identifier
4845803
Citation
Rutherford RL. The Lapidus procedure for primus metatarsus adductus. J Am Podiatry Assoc. 1974 Aug;64(8):581-4. doi: 10.7547/87507315-64-8-581. No abstract available.
Results Reference
background
PubMed Identifier
11324674
Citation
McInnes BD, Bouche RT. Critical evaluation of the modified Lapidus procedure. J Foot Ankle Surg. 2001 Mar-Apr;40(2):71-90. doi: 10.1016/s1067-2516(01)80048-x.
Results Reference
background
PubMed Identifier
3711593
Citation
Bacardi BE, Boysen TJ. Considerations for the Lapidus operation. J Foot Surg. 1986 Mar-Apr;25(2):133-8.
Results Reference
background
PubMed Identifier
1865058
Citation
Christenson C, Jones RO, Basque M, Mollohan E. Comparison of oblique closing base wedge osteotomies of the first metatarsal: stripping versus nonstripping of the periosteum. J Foot Surg. 1991 Mar-Apr;30(2):107-13.
Results Reference
background
PubMed Identifier
8829031
Citation
Hansen ST Jr. Hallux valgus surgery. Morton and Lapidus were right! Clin Podiatr Med Surg. 1996 Jul;13(3):347-54.
Results Reference
background
PubMed Identifier
10949807
Citation
Mendicino R, Catanzariti AR, Hofbauer M, Saltrick KR. The modified lapidus arthrodesis: technical maneuvers and pearls. J Foot Ankle Surg. 2000 Jul-Aug;39(4):258-64. doi: 10.1016/s1067-2516(00)80010-1. No abstract available.
Results Reference
background
PubMed Identifier
14414101
Citation
LAPIDUS PW. The author's bunion operation from 1931 to 1959. Clin Orthop. 1960;16:119-35. No abstract available.
Results Reference
result
PubMed Identifier
2744666
Citation
Sangeorzan BJ, Hansen ST Jr. Modified Lapidus procedure for hallux valgus. Foot Ankle. 1989 Jun;9(6):262-6. doi: 10.1177/107110078900900602.
Results Reference
result
PubMed Identifier
1601337
Citation
Myerson M, Allon S, McGarvey W. Metatarsocuneiform arthrodesis for management of hallux valgus and metatarsus primus varus. Foot Ankle. 1992 Mar-Apr;13(3):107-15. doi: 10.1177/107110079201300301.
Results Reference
result
PubMed Identifier
2653609
Citation
Hernandez A, Hernandez PA, Hernandez WA. Lapidus: when and why? Clin Podiatr Med Surg. 1989 Jan;6(1):197-208.
Results Reference
result
PubMed Identifier
10553545
Citation
Catanzariti AR, Mendicino RW, Lee MS, Gallina MR. The modified Lapidus arthrodesis: a retrospective analysis. J Foot Ankle Surg. 1999 Sep-Oct;38(5):322-32. doi: 10.1016/s1067-2516(99)80003-9.
Results Reference
result
PubMed Identifier
11232392
Citation
Myerson MS, Badekas A. Hypermobility of the first ray. Foot Ankle Clin. 2000 Sep;5(3):469-84.
Results Reference
result
PubMed Identifier
12194518
Citation
Ray RG. First metatarsocuneiform arthrodesis: technical considerations and technique modification. J Foot Ankle Surg. 2002 Jul-Aug;41(4):260-72. doi: 10.1016/s1067-2516(02)80025-4.
Results Reference
result
PubMed Identifier
16309603
Citation
Kopp FJ, Patel MM, Levine DS, Deland JT. The modified Lapidus procedure for hallux valgus: a clinical and radiographic analysis. Foot Ankle Int. 2005 Nov;26(11):913-7. doi: 10.1177/107110070502601103.
Results Reference
result
PubMed Identifier
14996919
Citation
Coetzee JC, Resig SG, Kuskowski M, Saleh KJ. The Lapidus procedure as salvage after failed surgical treatment of hallux valgus. Surgical technique. J Bone Joint Surg Am. 2004 Mar;86-A Suppl 1:30-6. doi: 10.2106/00004623-200403001-00005.
Results Reference
result
PubMed Identifier
2584630
Citation
Saffo G, Wooster MF, Stevens M, Desnoyers R, Catanzariti AR. First metatarsocuneiform joint arthrodesis: a five-year retrospective analysis. J Foot Surg. 1989 Sep-Oct;28(5):459-65.
Results Reference
result
PubMed Identifier
26235860
Citation
Gutteck N, Wohlrab D, Zeh A, Radetzki F, Delank KS, Lebek S. Immediate fullweightbearing after tarsometatarsal arthrodesis for hallux valgus correction--Does it increase the complication rate? Foot Ankle Surg. 2015 Sep;21(3):198-201. doi: 10.1016/j.fas.2014.11.010. Epub 2014 Dec 29.
Results Reference
result
PubMed Identifier
21189208
Citation
Goldstein CL, Schemitsch E, Bhandari M, Mathew G, Petrisor BA. Comparison of different outcome instruments following foot and ankle trauma. Foot Ankle Int. 2010 Dec;31(12):1075-80. doi: 10.3113/FAI.2010.1075.
Results Reference
result
PubMed Identifier
26763868
Citation
Prissel MA, Hyer CF, Grambart ST, Bussewitz BW, Brigido SA, DiDomenico LA, Lee MS, Reeves CL, Shane AM, Tucker DJ, Weinraub GM. A Multicenter, Retrospective Study of Early Weightbearing for Modified Lapidus Arthrodesis. J Foot Ankle Surg. 2016 Mar-Apr;55(2):226-9. doi: 10.1053/j.jfas.2015.09.003. Epub 2016 Jan 5.
Results Reference
result
PubMed Identifier
25451208
Citation
King CM, Richey J, Patel S, Collman DR. Modified lapidus arthrodesis with crossed screw fixation: early weightbearing in 136 patients. J Foot Ankle Surg. 2015 Jan-Feb;54(1):69-75. doi: 10.1053/j.jfas.2014.09.034. Epub 2014 Oct 31.
Results Reference
result
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Early Weight Bearing Tarsometatarsal Fusion Study
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