Association Between Patient Factors and Outcome of Synthetic Cartilage Implant Hemiarthroplasty vs First Metatarsophalangeal Joint Arthrodesis in Advanced Hallux Rigidus.
BACKGROUND
We evaluated data from a clinical trial of first metatarsophalangeal joint (MTPJ1) implant hemiarthroplasty and arthrodesis to determine the association between patient factors and clinical outcomes.


METHODS
Patients ≥18 years with hallux rigidus grade 2, 3, or 4 were treated with synthetic cartilage implant MTPJ1 hemiarthroplasty or arthrodesis. Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) sports and activities of daily living (ADL) scores, and Short Form-36 Physical Function (SF-36 PF) subscore were obtained preoperatively, and at 2, 6, 12, 24, 52, and 104 weeks postoperatively. Final outcome data, great toe active dorsiflexion motion, secondary procedures, radiographs, and safety parameters were evaluated for 129 implant hemiarthroplasties and 47 arthrodeses. The composite primary endpoint criteria for clinical success included VAS pain reduction ≥30%, maintenance/improvement in function, no radiographic complications, and no secondary surgical intervention at 24 months. Predictor variables included hallux rigidus grade; gender; age; body mass index (BMI); symptom duration; prior MTPJ1 surgery; preoperative hallux valgus angle, range of motion (ROM), and pain. Two-sided Fisher exact test was used ( P < .05).


RESULTS
Patient demographics and baseline outcome measures were similar. Success rates between implant MTPJ1 hemiarthroplasty and arthrodesis were similar ( P > .05) when stratified by hallux rigidus grade, gender, age, BMI, symptom duration, prior MTPJ1 surgery status, and preoperative VAS pain, hallux valgus, and ROM.


CONCLUSION
Synthetic cartilage implant hemiarthroplasty was appropriate for patients with grade 2, 3, or 4 hallux rigidus. Its results in those with associated mild hallux valgus (≤20 degrees) or substantial preoperative stiffness were equivalent to MTPJ1 fusion, irrespective of gender, age, BMI, hallux rigidus grade, preoperative pain or symptom duration.


LEVEL OF EVIDENCE
Level II, randomized clinical trial.
['Goldberg|Andy|A|', 'Singh|Dishan|D|', 'Glazebrook|Mark|M|', 'Blundell|Chris M|CM|', 'De Vries|Gwyneth|G|', 'Le|Ian L D|ILD|', 'Nielsen|Dominic|D|', 'Pedersen|M Elizabeth|ME|', 'Sakellariou|Anthony|A|', 'Solan|Matthew|M|', 'Younger|Alastair S E|ASE|', 'Daniels|Timothy R|TR|', 'Baumhauer|Judith F|JF|', '|||']
D000328:Adult D000367:Age Factors D000368:Aged D001174:Arthrodesis D005260:Female D005500:Follow-Up Studies D020859:Hallux Rigidus D062785:Hemiarthroplasty D006801:Humans D007595:Joint Prosthesis D008297:Male D008683:Metatarsophalangeal Joint D008875:Middle Aged D010147:Pain Measurement D018579:Patient Selection D011446:Prospective Studies D011474:Prosthesis Design D016059:Range of Motion, Articular D018570:Risk Assessment D012720:Severity of Illness Index D012737:Sex Factors D018709:Statistics, Nonparametric D013997:Time Factors D016896:Treatment Outcome
synthetic cartilage implant hemiarthroplasty first metatarsophalangeal joint hallux rigidus