Early Weight Bearing Tarsometatarsal Fusion Study

NCT03812237 | Completed

• 1 other identifier: OAM-TMT-01
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight Bearing Following Modified Lapidus Arthrodesis

Conditions

Hallux Valgus

Keywords

Lapidus Arthrodesis; Early Weight Bearing; First Tarsometatarsal Arthrodesis

Outcome Measures

Primary Outcomes (1)

• TMT Fusion Rate

  To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation.

  6 months

Secondary Outcomes (5)

• American Foot & Ankle Society Midfoot Scores (AOFAS)

  12 months

• Short Musculoskeletal Function Assessment (SMFA)

  12 months

• Visual Analogue Scale (VAS)

  12 months

• Foot Function Index Revised (FFIr)

  12 months

• Short Form Health Survey (SF-36) v.2

  12 months

Study Arms (2)

(EWB) Early Weight Bearing (2 Weeks Post-op)

EXPERIMENTAL

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.

Other: (EWB) Early Weight Bearing (2 Weeks Post-op)

(SOC) Standard of Care Weight Bearing (6-8 Weeks Post-op)

NO INTERVENTION

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.

Interventions

(EWB) Early Weight Bearing (2 Weeks Post-op) OTHER

Patient were permitted to progressively weightbear on their heel at 2 week post-op.

Also known as: EWB

(EWB) Early Weight Bearing (2 Weeks Post-op)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthopaedic Associates of Michigan, PC: lead
• Grand Rapids Medical Education Partners: collaborator

Study Sites (1)

Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, 49525, United States

Location

Related Publications (23)

• 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.

  PMID: 11128011 BACKGROUND

• 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.

  PMID: 2825872 BACKGROUND

• 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.

  PMID: 19232969 BACKGROUND

• 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.

  PMID: 4845803 BACKGROUND

• 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.

  PMID: 11324674 BACKGROUND

• Bacardi BE, Boysen TJ. Considerations for the Lapidus operation. J Foot Surg. 1986 Mar-Apr;25(2):133-8.

  PMID: 3711593 BACKGROUND

• 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.

  PMID: 1865058 BACKGROUND

• Hansen ST Jr. Hallux valgus surgery. Morton and Lapidus were right! Clin Podiatr Med Surg. 1996 Jul;13(3):347-54.

  PMID: 8829031 BACKGROUND

• 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.

  PMID: 10949807 BACKGROUND

• LAPIDUS PW. The author's bunion operation from 1931 to 1959. Clin Orthop. 1960;16:119-35. No abstract available.

  PMID: 14414101 RESULT

• Sangeorzan BJ, Hansen ST Jr. Modified Lapidus procedure for hallux valgus. Foot Ankle. 1989 Jun;9(6):262-6. doi: 10.1177/107110078900900602.

  PMID: 2744666 RESULT

• 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.

  PMID: 1601337 RESULT

• Hernandez A, Hernandez PA, Hernandez WA. Lapidus: when and why? Clin Podiatr Med Surg. 1989 Jan;6(1):197-208.

  PMID: 2653609 RESULT

• 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.

  PMID: 10553545 RESULT

• Myerson MS, Badekas A. Hypermobility of the first ray. Foot Ankle Clin. 2000 Sep;5(3):469-84.

  PMID: 11232392 RESULT

• 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.

  PMID: 12194518 RESULT

• 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.

  PMID: 16309603 RESULT

• 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.

  PMID: 14996919 RESULT

• 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.

  PMID: 2584630 RESULT

• 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.

  PMID: 26235860 RESULT

• 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.

  PMID: 21189208 RESULT

• 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.

  PMID: 26763868 RESULT

• 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.

  PMID: 25451208 RESULT

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients were blinded to treatment until their 2 week post-operative visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon - Foot and Ankle

Model Details: Prospective, Randomized, Controlled Trial

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: January 20, 2012
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)