Evaluation and Validation of the Dutch European Foot and Ankle Society (EFAS) Score.

The European Foot and Ankle Society (EFAS) score is a recently developed foot and ankle patient-reported outcome measure. It has been developed and partly validated in seven languages. This study's aim was to investigate the measurement properties of the Dutch version of the EFAS score. Subscales of the Dutch EFAS score were evaluated in 547 patients with a variety of foot and ankle diagnoses. Floor and ceiling effect, reliability, and construct validity were assessed. The internal consistency of the EFAS score was acceptable (Cronbach's alpha 0.79-0.94). Repeatability was considered poor, with intraclass correlation coefficients between 0.32 and 0.39. Construct validity was inadequate with confirmation of 67% of the hypothesized correlations. In conclusion, the Dutch version of the EFAS score does not have adequate measurement properties for use in patient with patients with varying foot and ankle problems.

EFAS Score - Multilingual development and validation of a patient-reported outcome measure (PROM) by the score committee of the European Foot and Ankle Society (EFAS).

BACKGROUND: A scientifically sound validated foot and ankle specific score validated ab initio for different languages is missing. The aim of a project of the European Foot and Ankle Society (EFAS) was to develop, validate, and publish a new score(the EFAS-Score) for different European languages. METHODS: The EFAS Score was developed and validated in three stages: (1) item (question) identification, (2) item reduction and scale exploration, (3) confirmatory analyses and responsiveness. The following score specifications were chosen: scale/subscale (Likert 0-4), questionnaire based, outcome measure, patient related outcome measurement. For stage 3, data were collected pre-operatively and at a minimum follow-up of 3 months and mean follow-up of 6 months. Item reduction, scale exploration, confirmatory analyses and responsiveness were executed using analyses from classical test theory and item response theory. RESULTS: Stage 1 resulted in 31 general and 7 sports related questions. In stage 2, a 6-item general EFAS Score was constructed using English, German, French and Swedish language data. In stage 3, internal consistency of the scale was confirmed in seven languages: the original four languages, plus Dutch, Italian and Polish (Cronbach's Alpha >0.86 in all language versions). Responsiveness was good, with moderate to large effect sizes in all languages, and significant positive association between the EFAS Score and patient-reported improvement. No sound EFAS Sports Score could be constructed. CONCLUSIONS: The multi-language EFAS Score was successfully validated in the orthopaedic ankle and foot surgery patient population, including a wide variety of foot and ankle pathologies. All score versions are freely available at www.efas.co.

Are current foot- and ankle outcome measures appropriate for the evaluation of treatment for osteoarthritis of the ankle?: Evaluation of ceiling effects in foot- and ankle outcome measures.

BACKGROUND: Many PROMs used for evaluation of ankle osteoarthritis are not validated for this purpose. We hypothesize that frequently used PROMs have an early ceiling or floor effect. METHODS: We prospectively collected data from patients with ankle osteoarthritis between 2011 and 2013. At baseline visit patients completed the Foot and Ankle Outcome Score, the Ankle Osteoarthritis Score, the American Orthopaedic Foot and Ankle Society scale, a visual analogue scale for pain and quality of life. Outcomes were analyzed for floor or ceiling effects. RESULTS: 197 patients were included in the study. A floor effect was present for the AOFAS and VAS for pain in all groups. Floor and ceiling effect are absent for the FAOS outcome measure for all groups. CONCLUSIONS: Physicians should be aware of floor or ceiling effects when evaluating treatment using patient reported outcome measures. The FAOS outcome measure lacks early ceiling or floor effects.

The effect of posture on the osseous relations in the foot.

BACKGROUND: Discrepancies observed between clinical findings and a weightbearing foot X-ray might be caused by a patients' positioning. This study's main objective was to determine the effect of a subjects' posture on the osseous relations of the foot. METHODS: Anatomical markers were placed on the skin of the foot of 17 subjects. A plantar pressure plate assessed the percentage weight on the foot and weight distribution over the foot. Medial longitudinal foot angles were derived from the markers and compared between the 10 postures. The effect of percentage weight and weight distribution on the foot angles was determined by multiple regression analysis. RESULTS: The foot angles were significantly affected by the postures. The multiple regression analysis revealed the weight on the foot and the mediolateral weight distribution over the foot as important factors for the foot angles. CONCLUSION: A subjects posture significantly influences the osseous relations in the foot.

Hyaluronic acid and other conservative treatment options for osteoarthritis of the ankle.

BACKGROUND: The cause of ankle osteoarthritis (OA) is usually trauma. Patients are relatively young, since ankle trauma occurs at a relatively young age. Several conservative treatment options are available, evidence of the benefits and harms of these options are lacking. OBJECTIVES: To assess the benefits and harms of any conservative treatment for ankle OA in adults in order to provide a synthesis of the evidence as a base for future treatment guidelines. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2014, issue 9), MEDLINE (Ovid) (1946 up to 11 September 2014), EMBASE (1947 to September 2014), PsycINFO (1806 to September 2014), CINAHL (1985 to September 2014), PEDro (all years till September 2014), AMED until September 2014, ClinicalTrials.gov, Current Controlled Trials, The Dutch Register. To identify potentially relevant studies we screened reference lists in retrieved review articles and trials. SELECTION CRITERIA: We considered randomised or controlled clinical trials investigating any non-surgical intervention for ankle OA for inclusion. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: No other RCT concerning any other conservative treatment besides the use of hyaluronic acid (HA) for ankle OA was identified. Six randomised controlled trials (RCTs) were included.A total of 240 participants diagnosed with ankle OA were included in this review. The primary analysis included three RCTs (109 participants) which compared HA to placebo. One study compared HA to exercise therapy, one compared HA combined with exercise therapy to an intra-articular injection of botulinum toxin and one compared four different dosages of HA.Primary analysis: a pooled analysis of two trials (45 participants) found that the Ankle Osteoarthritis Scale (AOS) total score (measuring pain and physical function) was reduced by 12% (95% CI -24% to -1%) at six months (mean difference (MD) -12.53 (95% CI -23.84 to -1.22) on a scale of 0 to 100; number needed to treat for an additional beneficial outcome (NNTB) = 4 (95% CI 2 to 205); this evidence was graded as low quality, due to limitations in study design (unclear risk of selection bias for two studies and unclear risk for attrition bias for one study) and imprecision of results: a small population size (45 participants). It is not known if a mean difference of 12.53 points on a 100 point scale is clinically relevant. No minimal important clinical difference is known for this score. Pain and function outcomes were not reported separately. Radiographic joint structure changes were not investigated. For the mean quality of life at six months (two trials; 45 participants) no meta-analysis could be performed due to missing data. No serious adverse events (SAEs) were noted and no participants withdrew because of an adverse event. There were a few adverse events (AEs) 5/63 (8%) in the HA group and 2/46 (4%) in the placebo group. The Peto odds ratio (Peto OR) to have an adverse event was 2.34 higher compared to the control group (95% CI 0.45 to 12.11). This evidence is inconclusive because of a wide CI and a small number of events.For comparing HA to exercise therapy (30 participants) the results for pain on a Visual Analogue Scale (VAS 0 to 10) at 12 months are inconclusive (MD 0.70, 95% CI -2.54 to 1.14). The American Orthopedic Foot and Ankle Society score (AOFAS score) was 13.10 points (MD) higher in favour of HA (95% CI 2.97 to 23.23) on a scale of 0 to 100. The evidence was graded as low. No adverse events were found. Radiographic structure changes were not measured; no participants withdrew due to AEs; no SAEs were found.For the comparison of HA injection combined with exercise therapy to an intra-articular injection of botulinum toxin A (BoNT-A) (75 participants), the outcome of the AOS pain score of the affected joint at six months is inconclusive (MD 0.10, 95% CI -0.42 to 0.62). The physical function (the AOS disability score) at six months is inconclusive (MD 0.20, 95% CI -0.34 to 0.74). The same number of AEs were found in both groups; HA 2/37 (5.9%), BoNT-A 2/38 (5.8%) (risk ratio (RR) 1.03, 95% CI 0.15 to 6.91). Radiographic changes were not examined, no SAEs were found and no participants withdrew because of an AE. The evidence was graded as low.The RCT comparing four different dosing schedules for HA (26 participants) showed the best median decrease in pain on walking VAS (on a scale of 0 to 100) for 3 x 1 ml at 27 weeks with a median decrease of 30. Physical function, radiographic changes and quality of life were not measured.Twenty-seven percent of all participants had AEs, most of them in the 2ml group (57% in this group). No participants withdrew due to an AE and no SAEs were noted.Overall the quality of the evidence showed some serious limitations. The evidence was graded low for the primary analysis comparing HA to placebo. This was based on a limitation in design and implementation: sample sizes were small (45 to 92 participants) and and imprecision in results: there was an unclear risk of bias for several items concerning the three studies used in the meta analysis. AUTHORS' CONCLUSIONS: Currently, there is insufficient data to create a synthesis of the evidence as a base for future guidelines for ankle OA. Since the aetiology of ankle OA is different, guidelines that are currently used for hip and knee OA may not be applicable for ankle OA. Simple analgesics as recommended for hip and knee OA seem however a reasonable first step to treat ankle OA. It is unclear if there is a benefit or harm for HA as treatment for ankle OA compared to placebo at six months based on a low quality of evidence. Inconclusive results were found comparing HA to other treatments. HA can be conditionally recommended if patients have an inadequate response to simple analgesics. It remains unclear which patients (age, grade of ankle OA) benefit the most from HA injections and which dosage schedule should be used.

The impact of ankle osteoarthritis. The difference of opinion between patient and orthopedic surgeon.

BACKGROUND: Outcome measures for ankle osteoarthritis (OA) are created by physicians with little input of the target patient group. The aim of this study was to determine the difference in opinion between patients and orthopedic surgeons concerning the importance of specific symptoms of ankle OA and its impact on daily life and function. METHODS: A modified Delphi method was applied, consisting of structured interviews with patient focus groups and experts, followed by a poll using 32 statements. The difference in opinion between patients and orthopedic surgeons was evaluated. RESULTS: Forty patients and forty orthopedic surgeons responded to the 32 statements. Statistically significant differences in opinion on symptoms, function and the impact of ankle OA on daily life were found. CONCLUSIONS: This study demonstrates a significant difference in opinion between patients and orthopedic surgeons concerning specific symptoms of ankle OA. These results advocate incorporating the needs and demands of the individual patient for new outcome measures.

The optimal injection technique for the osteoarthritic ankle: a randomized, cross-over trial.

BACKGROUND: To optimize the injection technique for the osteoarthritic ankle in order to enhance the effect of intra-articular injections and minimize adverse events. METHODS: Randomized cross-over trial. Comparing two injection techniques in patients with symptomatic ankle osteoarthritis. Patients received an injection with hyaluronic acid using either one of the techniques. Four weeks later the second injection was given using the other technique. Primary outcome was the failure rate of the injection. RESULTS: Seventy patients fulfilled the study. The failure rate for both injection techniques was 24%. Forty-one patients in the traction group and thirty-nine in the group without traction experienced treatment related local adverse events. Other secondary outcomes did not show any difference between injection techniques. CONCLUSIONS: There is no significant difference comparing the two injection methods regarding any of our formulated outcome measures. The use of contrast aided fluoroscopy for injecting the severe osteoarthritic ankle can be advised at all times.

Intra-articular sodium hyaluronate injections in the osteoarthritic ankle joint: effects, safety and dose dependency.

BACKGROUND: To determine the efficacy, safety and dose dependency of intra-articular Orthovisc(®) hyaluronic acid injections in the ankle. METHODS: A prospective single blinded study in patients with symptomatic ankle-osteoarthritis. Patients were randomly allocated to 1, 2, 3 ml, or 3 weekly injections of 1 ml (3 × 1 ml). Primary outcome was 'pain during walking' at 15 weeks measured on a 100mm VAS. RESULTS: Twenty-six patients (ITT) participated. The 3 × 1 ml dose group showed statistically significant decreases at week 7 for 'pain during walking' and 'pain at rest' (p=0.046). At week 15 decreases were significant for 'pain at rest' (p=0.046). There was no significant decrease of VAS-scores in any of the single dose groups. Seven patients experienced temporary local swelling and increased pain in the injected ankle. CONCLUSIONS: Orthovisc(®) viscosupplementation in the ankle joint is effective and well tolerated. The 3 × 1 ml dose regimen shows the best results.

A prospective multi-centre, open study of the safety and efficacy of hylan G-F 20 (Synvisc) in patients with symptomatic ankle (talo-crural) osteoarthritis.

BACKGROUND: To evaluate the safety and efficacy of hylan G-F 20 in patients with ankle osteoarthritis. METHODS: A prospective, open study in patients with symptomatic (>or=50 mm and