Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus

Baumhauer, Judith F.; Singh, Dishan; Glazebrook, Mark; Blundell, Chris; Vries, Gwyneth de; Le, Ian; Nielsen, Dominic; Pedersen, M. Elizabeth; Sakellariou, Anthony; Solan, Matthew; Wansbrough, Guy; Younger, Alastair; Daniels, Timothy R.

doi:10.1177/1071100716635560

Cited by 155 publications

(223 citation statements)

References 18 publications

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“…Each of these 4 questions was accompanied by a 100‐mm VAS, with the pain questions anchored by the statements “no pain” and “worst pain possible” and the stiffness questions anchored by the statements “not stiff at all” to “most stiff possible.” To avoid clustering of scores, no verbal descriptors at intermediate points were used . We chose VAS rather than numerical rating scales because the VAS have been used in 2 of the 4 clinical trials for this condition .…”

Section: Methodsmentioning

confidence: 99%

“…Despite the high prevalence and burden of OA of the first MTP joint, relatively little research has been undertaken to evaluate commonly used treatments for this condition , and there is no consensus as to which outcome measures should be used to assess treatment effectiveness. Of the 4 randomized trials that have been undertaken to assess interventions for OA of the first MTP joint, 2 used generic visual analog scales (VAS) of pain , and 2 used the pain domain of the Foot Health Status Questionnaire (FHSQ) as the primary outcome measure. However, recent reviews of measures of foot function, foot health, and foot pain indicate that while several questionnaires have been developed, very few of these outcome measures have undergone adequate psychometric evaluation.…”

Section: Introductionmentioning

confidence: 99%

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Comparative Responsiveness of Outcome Measures for the Assessment of Pain and Function in Osteoarthritis of the First Metatarsophalangeal Joint

Menz

Auhl

Tan

et al. 2020

Arthritis Care & Research

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Objective. The present study was undertaken to assess the comparative responsiveness of outcome measures used for the assessment of pain and function in individuals with osteoarthritis (OA) of the first metatarsophalangeal (MTP) joint.Methods. Eighty-eight patients (mean ± SD age 57.2 ± 10.2 years) with OA of the first MTP joint who participated in a randomized trial completed the Foot Health Status Questionnaire (FHSQ), the Foot Function Index Revised Short Form (FFI-RS), and 100-mm visual analog scales (VAS) of pain and stiffness at baseline and 12 weeks. Responsiveness of the subscales for each outcome measure was determined using paired t-tests, Cohen's d coefficient, the standardized response mean (SRM), and the Guyatt index (GI). Sample size estimations were calculated based on minimal important differences (MIDs).Results. All outcome measures were sensitive to change and demonstrated at least medium effect sizes. Three outcome measures exhibited large or very large effect sizes for Cohen's d coefficient, the SRM, and the GI: the FHSQ pain subscale (d = 1.03; SRM 1.10, GI score 1.30), the FFI-RS pain subscale (d = 1.09; SRM 1.05, GI score 1.73), and the 100-mm VAS of pain severity while walking (d = 1.22; SRM 1.07, GI score 1.78). Sample size calculations indicated that between 20 and 33 participants per group would be required to detect MIDs using these measures.Conclusion. The FHSQ pain subscale, FFI-RS pain subscale, and the 100-mm VAS of pain severity while walking are the most responsive outcome measures for the assessment of pain and function in individuals with OA of the first MTP joint. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparative Responsiveness of Outcome Measures for the Assessment of Pain and Function in Osteoarthritis of the First Metatarsophalangeal Joint

Menz

Auhl

Tan

et al. 2020

Arthritis Care & Research

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“…Baumhauer et al reported equivalent reduction in VAS pain scores and improvement in FAAM sports functional scores with the synthetic implant and first MTP arthrodesis. 35 Synthetic cartilage patients had an average of 4° of improvement in dorsiflexion and a revision rate of 9.2% to arthrodesis. While longer survivorship analysis is planned, this implant offers encouraging results.…”

Section: Operative Managementmentioning

confidence: 99%

Hallux rigidus

Baumhauer

2017

EFORT Open Reviews

112

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An estimated 40% of the US population have foot problems.Of all patients aged over 50 years, 2.5% report degenerative arthritis of the first metatarsophalangeal (MTP) joint, termed ‘hallux rigidus’. First MTP osteoarthritis is the most common arthritic condition in the foot.Progression of great toe arthritis is associated with pain and loss of motion. Non-surgical intervention begins with shoe modifications and orthotics designed to limit MTP motion.In patients with mild arthritis, operative procedures focus on removing excess osteophytes (cheilectomy) to prevent dorsal impingement with or without a concomitant osteotomy (Moberg) to improve or shift range of motion into a less painful arc.In patients with more advanced arthritis, operative management has centred on arthrodesis of the first MTP joint.A recent Level 1 study shows excellent function and pain relief with a small hydrogel hemi-implant into the metatarsal headMultiple joint-sparing procedures such as joint arthroplasty or resurfacing have been described with inconsistent results. Cite this article: EFORT Open Rev 2017;2:13–20. DOI: 10.1302/2058-5241.2.160031

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“…Baumhauer et al[5] described the use of a synthetic cartilage implant as an allograft interpositional spacer. This synthetic cartilage implant (Cartiva, Inc., Alpharetta, GA, United States) is 8 or 10 mm in diameter and requires minimal bone and joint resection for implantation.…”

Section: Interpositional Arthroplastymentioning

confidence: 99%

“…Consequently, individuals with hallux rigidus experience joint pain and decreased range of motion (ROM) in the sagittal plane. This leads to altered gait mechanics and significant reduction in activity and quality of life for patients[4,5]. …”

Section: Introductionmentioning

confidence: 99%

Hallux rigidus: How do I approach it?

Lam¹,

Chan²,

Surace³

et al. 2017

WJO

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Hallux rigidus is a degenerative disease of the first metatarsalphalangeal (MTP) joint and affects 2.5% of people over age 50. Dorsal osteophytes and narrowed joint space leads to debilitating pain and limited range of motion. Altered gait mechanics often ensued as 119% of the body force transmit through the 1st MTP joint during gait cycle. Precise etiology remains under debate with trauma being often cited in the literature. Hallux valgus interphalangeus, female gender, inflammatory and metabolic conditions have all been identified as associative factors. Clinical symptoms, physical exam and radiographic evidence are important in assessing and grading the disease. Non-operative managements including nonsteroidal antiinflammatory drugs, intra-articular injections, shoe modification, activity modification and physical therapy, should always be attempted for all hallux rigidus patients. The goal of surgery is to relieve pain, maintain stability of the first MTP joint, and improve function and quality of life. Operative treatments can be divided into joint-sparing vs joint-sacrificing. Cheilectomy and moberg osteotomy are examples of joint-sparing techniques that have demonstrated great success in early stages of hallux rigidus. Arthrodesis is a joint-sacrificing procedure that has been the gold standard for advanced hallux rigidus. Other newer procedures such as implant arthroplasty, interpositional arthroplasty and arthroscopy, have demonstrated promising early patient outcomes. However, future studies are still needed to validate its long-term efficacy and safety. The choice of procedure should be based on the condition of the joint, patient’s goal and expectations, and surgeon’s experience with the technique.

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Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus

Abstract: Level I, prospective randomized study.

Cited by 155 publications

References 18 publications

Comparative Responsiveness of Outcome Measures for the Assessment of Pain and Function in Osteoarthritis of the First Metatarsophalangeal Joint

Comparative Responsiveness of Outcome Measures for the Assessment of Pain and Function in Osteoarthritis of the First Metatarsophalangeal Joint

Hallux rigidus

Hallux rigidus: How do I approach it?

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