ArticleClinical medicine insights. Arthritis and musculoskeletal disorders2022
Open-Label Pilot Study of a Single Intra-Articular Injection of Mannitol-Modified Cross-Linked Hyaluronic Acid (HANOX-M-XL) for the Treatment of the First Metatarsophalangeal Osteoarthritis (Hallux Rigidus): The REPAR Trial.
Article in Clinical medicine insights. Arthritis and musculoskeletal disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed, 5 citations in OpenAlex.
- Trial
- Range of Flexion Improvement in Degenerative Stages of the First Metatarsophalangeal Joint (Journal of functional morphology and kinesiology · 2024Article
- Limited Evidence to Support the Use of Intra-Articular Injection of Hyaluronic Acid for the Management of Hallux Rigidus: A Systematic Review.Foot & ankle orthopaedics · 2024Article
- Good Short- and Mid-term Outcome After Cross-Linked Hyaluronic Acid Infiltration for Hallux Rigidus: A Case Report.Clinical medicine insights. Arthritis and musculoskeletal disorders · 2024Article
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Authors and funding
5 authors at 4 institutions in 1 country.
Funding
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Abstract
Purpose: The purpose of this study was to obtain information on safety and short-term efficiency of a single intra-articular injection of mannitol-modified cross-linked hyaluronic acid (HANOX-M-XL) in patients with painful first metatarsophalangeal joint osteoarthritis (1stMTPJ-OA). Methods: The study involved an observational, single-arm, prospective multicentre trial, with a 3-month follow-up. Inclusion criteria were patients with symptomatic 1st MTPJ-OA not relieved by analgesics and / or non-steroidal-anti-inflammatory drugs and / or foot orthotic. All patients received a single, imaging-guided intra-articular (IA) injection of 1 mL of HANOX-M-XL in the 1st MTPJ. The primary outcome was the change in pain between the date of injection and month 3. The secondary outcomes were the patient assessment of effectiveness, the decrease in painkiller use and the influence of the radiographic score on the clinical efficacy. Results: Sixty-five participants (72.3% women, mean age = 60) were included in the trial. Coughlin-Shurnas radiological grade was 1 in 28 patients, 2 in 29, and 3 in 6. At baseline and month 3, the average pain (0-10) was 6.5 ± 1.8 and 2.8 ± 2.3, respectively. The change in pain score was highly significant (-3.1 ± 2.9; Conclusion: This pilot study suggests that a single IA injection of HANOX-M-XL is safe and mainly benefits patients with mild moderate 1st MTPJ-OA. Further randomized controlled trials are necessary to confirm these preliminary encouraging results.
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