Early Weight Bearing Tarsometatarsal Fusion Study

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812237
• Other study ID #: OAM-TMT-01
• Status: Completed
• Phase: N/A
• Start date: January 20, 2012
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2019
• Source: Orthopaedic Associates of Michigan, PC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Other:
• (EWB) Early Weight Bearing (2 Weeks Post-op)
Patient were permitted to progressively weightbear on their heel at 2 week post-op.

Locations

Country	Name	City	State
United States	Orthopaedic Associates of Michigan, PC	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Orthopaedic Associates of Michigan, PC	Grand Rapids Medical Education Partners

Country where clinical trial is conducted

United States, 

References & Publications (23)

Bacardi BE, Boysen TJ. Considerations for the Lapidus operation. J Foot Surg. 1986 Mar-Apr;25(2):133-8. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.20 — View Citation

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

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

LAPIDUS PW. The author's bunion operation from 1931 to 1959. Clin Orthop. 1960;16:119-35. — View Citation

McInnes BD, Bouché RT. Critical evaluation of the modified Lapidus procedure. J Foot Ankle Surg. 2001 Mar-Apr;40(2):71-90. — View 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. — View 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. — View Citation

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

Ray RG. First metatarsocuneiform arthrodesis: technical considerations and technique modification. J Foot Ankle Surg. 2002 Jul-Aug;41(4):260-72. — View Citation

Rutherford RL. The Lapidus procedure for primus metatarsus adductus. J Am Podiatry Assoc. 1974 Aug;64(8):581-4. — View 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. — View Citation

Sangeorzan BJ, Hansen ST Jr. Modified Lapidus procedure for hallux valgus. Foot Ankle. 1989 Jun;9(6):262-6. — View 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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TMT Fusion Rate	To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation.	6 months
Secondary	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)]	12 months
Secondary	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)]	12 months
Secondary	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)]	12 months
Secondary	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.	12 months
Secondary	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.	12 months