Matthew Beuchel MD 2 C. Luke Rust MD 3 Jessica Hooper MD 3

Transcription

1 A Prospective, Randomized,Controlled Trial Comparing Early- Weightbearing vs. Non-Weightbearing Following Modified Lapidus Arthrodesis Intermediate Results - Donald R. Bohay, MD, FACS Professor, Michigan State University College of Human Medicine Private Practice: Orthopaedic Associates of Michigan, PC Director, Grand Rapids Orthopaedic Foot and Ankle Fellowship Grand Rapids, MI John G Anderson MD 1 Donald R Bohay MD 1 John D Maskill MD 1 Matthew Beuchel MD 2 C. Luke Rust MD 3 Jessica Hooper MD 3 Rebecca Wakeman MD 5 Michelle A Padley BS, CRMT 1 Lindsey A Behrend BS 1 Background First tarsometatarsal (TMT) arthrodesis (modified Lapidus arthrodesis) is an accepted method of correcting varying degrees of hallux valgus with or without associated first ray insufficiency. Concerning post-operative course, surgeons have historically followed a cautious postoperative regimen permitting either non-weight bearing or conservative heel touchdown ambulation. These restrictions are in place for approximately six to eight weeks until bone consolidation is confirmed radiographically. More recently, an alternative approach to post-operative management has been advocated in which patients are allowed to begin progressive weight bearing as tolerated beginning at two weeks after surgery. The goals of this updated protocol are to improve compliance and enhance patient mobility. Purpose The purpose of this study is to report intermediate outcomes in patients who have undergone modified Lapidus arthrodesis and were randomized to an early weight bearing protocol at two weeks post-operatively, or to the six to eight week non-weight bearing course. Surgical Treatment Options 57 patients: 52 female, 7 male Mean age years (range 20-75) 18/57 had previous surgical correction of midfoot deformity 3/18 ipsilateral (non-fusion) 15/18 contralateral bunion correction procedure Mean length of failed conservative treatment 5.41 years

2 Procedure A dorsal longitudinal incision was performed, and the TMT joint was identified. Care was taken in order to protect the superficial peroneal nerve. Following removal of remaining articular cartilage the joint spaces were prepared for fusion by perforating with a 2.0 drill. The joint is manually manipulated into position, held in place by K-wires. The positioning was then confirmed to be in good position with fluoroscopy. The fusion is then fixated by crossed screws, placed in the lag fashion. X rays were ordered, demonstrating optimal positioning of hardware and fusion. Concomitant Procedures Gastrocnemius Recession Modified McBride 42/57 Patients 44/57 Patients 1-2 Intercuniform Fusion 45/57 Patients 1-2 Intermetarsal Fusion 50/57 Patients 2 nd Metatarsal Shortening Osteotomy 25/57 Patients Weightbearing Instructions All patients were non-weightbearing until 2 week post-operative visit. At that point, patients were randomized to either early weightbearing or control weightbearing groups. Early Weightbearing patients were instructed to heel touch weight bear only for the first week, and then follow the progressive weightbearing protocol: o With their heel only, begin weightbearing at 50lbs. Every 4 days, increase weight on the operative foot at 25lb increments. Patients could anticipate to be fullweightbearing at the end of two weeks. Control Weightbearing patients were instructed to remain strictly nonweightbearing until the 6 8 week post-operative visit. At the 6-8 week post-operative visit, both groups were fitted with a fixed ankle support boot. Early Weightbearing patients could now walk on their forefoot, and could wean out of the boot as tolerated (minimum of 4 weeks) Control Weightbearing patients were instructed to follow the progressive weightbearing protocol above, bearing weight on their whole foot. Results: Post-Operative Swelling

3 6 Weeks (33/40) EWB 82.5% swelling (16/17) SOC 94.1% swelling not (quite) significant: p = Months (28/40) EWB 70% swelling (12/17)SOC 70.6% swelling not significant: p = Months (16/40) EWB 40% swelling (8/17)SOC 47.1% swelling not significant: p = Months (9/40) EWB 22.5% swelling (3/17)SOC 17.6% swelling not significant: p =.435 Results: Union Status Fusion Rates: o Control Group: 100% o EWB Group: 92.5% For the completed study, it will be assumed that the control group will achieve 90% fusion and that the early bearing group will achieve 70% fusion, with alpha = 0.05 and beta = 0.20, we will be able to detect a statistically significant effect with 59 subjects in each group, using the chi-square test Results: Union Rates 6 Months EWB: 38/40 (2 delayed) Control: 17/17 o p =.415 Tobacco History: o nonsmokers: 36/36 fused o C&F*: 2/19 delayed o not (quite) significant: p =.106 BMI: p =.840 Age at Surgery: p = months EWB: 37/40 Uninterpretable patient was found to be delayed after CT following one year follow-up, treated with bone stimulator Control: 17/17 o p =.495 Tobacco History: o nonsmokers: 36/36 fused o C&F:3/19delayed (1 current, 2 former) p =.076 BMI: p =.945 Age at Surgery: p =.841

4 VAS Scores Early-Weightbearing: Standard of Care: not significant p =.589 Time to Full Weightbearing EWB (40 patients): days avg (sd ) SOC (17 patients): days avg (sd ) significant p =.000 SF-36 Scoring Dimensions Group 6 Weeks 3 Months 6 Months 1 Year Social Function Emotional Mental Health (A) Physical Function Mental Health (B) Total Research Report: Midfoot Reconstruction for Primary Atraumatic Arthritis: Analysis of Outcomes 6 Weeks No significant: p =.087 o (2/40) EWB o (0/17)SOC 3 Months (EWB 5 SOC 1) not significant: p =.414 o (5/40) EWB o (1/17)SOC 6 Months (EWB 13 SOC 2) not significant: p =.141 o (13/40) EWB o (2/17)SOC 12 Months (EWB 12 SOC 2) not significant: p =.134 o (12/40) EWB o (2/17)SOC Patient Satisfaction Early Weightbearing 35/40 would do the procedure again. o 5/40 (no, unsure, not answered) 29/40 were satisfied with the outcome o 11/40 (no, unsure, not answered) 34/40 were happy with their assigned WB group o 6/40 (no, unsure, not answered Standard of Care 16/17 would do the procedure again. o 1/17 (unsure) 15/17 were satisfied with the outcome

5 o 2/17 (no, unsure) 10/17 were happy with their assigned WB group o 7/17 (no) Conclusions There is no statistically significant different in fusion rates or VAS pain scores. We noted significant differences in the number of days to full-weightbearing, as well as physical function scores at that 6-7 week visit. Patients have reported that they are able to get back to normal activities more quickly in the early-weightbearing group. Further enrollment and follow-up are needed. One of the difficulties of this study was the popularity of early weightbearing for patients. 9 patients withdrew at the 2 week visit after they were randomized to control. References: 1. Lapidus, P. The author s bunion operation from 1931 to Clin Orthop 16: , Sangeorzan, B., Hansen, S. Modified Lapidus procedure for hallux valgus. Foot Ankle 9 (6): , Myerson, M., Allon, S., McGarvey, W. Metatarsocuneiform arthrodesis for management of hallux valgus and metatarsus primus varus. Foot Ankle 13(3): , Bednarz, P.A., Manoli, A. 2nd. Modified Lapidus procedure for the treatment of hypermobile hallux valgus. Foot Ankle Int 21(10): , Clark, H.R., Veith, R.G., Hansen, S.T. Jr. Adolescent bunions treated by the modified Lapidus procedure. Bull Hosp Jt Dis Orthop Inst 47(2): , 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 48(2): , Hernandez, A., Hernandez, P., Hernandez, W. Lapidus: when and why? Clin Podiatr Med Surg 6(1): , Catanzariti, A., Mendicino, R., Lee, M., Gallina, M. The modified Lapidus arthrodesis: a retrospective analysis. J Foot Ankle Surg 38(5): , Myerson, M.S., Badekas, A. Hypermobility of the first ray. Foot Ankle Clin 5(3): , Ray, R.G. First metatarsocuneiform arthrodesis: technical considerations and technique modification. J Foot Ankle Surg 41(4): , Kopp, F.J., Patel, M.M., Levine, D.S., Deland, J.T. The modified Lapidus procedure for hallux valgus: a clinical and radiographic analysis. Foot Ankle Int 26(11): , Rutherford, R. The Lapidus procedure for primus metatarsus adductus. J Am Podiatry Assoc 64(8): , McInnes, B., Bouche, R. Critical evaluation of the modified Lapidus procedure. J Foot Ankle Surg 40(2):71 90, 2001.

6 14. Bacardi, B., Boysen, T. Considerations for the Lapidus operation. J Foot Surg 25(2): , Coetzee, C., Resig, S., Kuskowski, M., Saleh, K. The Lapidus procedure as salvage after failed surgical treatment of hallux valgus. J Bone Joint Surg Am 86-A(Suppl 1):30 36, Saffo, G.,Wooster, M., Desnoyers, R., Catanzariti, A., Stevens, M. First metatarsocuneiform joint arthrodesis: a five year retrospective analysis. J Foot Surg 28(5): , Christenson, C., Jones, R.O., Basque, M., Mollohan, E. Comparison of oblique closing base wedge osteotomies of the first metatarsal: stripping versus nonstripping of the periosteum. J Foot Surg 30(2): , Hansen, S.T. Hallux valgus surgery. Morton and Lapidus were right! Clin Podiatr Med Surg 13(3): , Mendicino, R., Catanzariti, A.R., Hofbauer, M., Saltrick, K.R. The modified Lapidus arthrodesis: technical