Bone fractures
Conditions
Interventions
This is a randomized, controlled, double-blind clinical study with three arms and a convenience sample size. This is a continuation of the follow-up of a previous study, which demonstrated an evaluati
Sponsors
Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad
Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad
Eligibility
Inclusion criteria
Inclusion criteria: Patients of both genders; who underwent intra-articular infiltration for the treatment of symptomatic subtalar osteoarthritis secondary to calcaneal fracture at the National Traumatology and Orthopedics Institute between 2017 and 2018 (at the time of the trauma, all patients were treated with osteosynthesis of the calcaneus with a Kirschner wire, a standard treatment at the foot service and ankle of the Institution); and who were selected to participate in a study to evaluate the outcomes of subtalar osteoarthritis after intra-articular injections
Exclusion criteria
Exclusion criteria: Patients with subtalar ankylosis; previous infection; radiographic parameters compatible with inadequate joint reduction; hypersensitivity to hyaluronic acid; pregnancy and breastfeeding; concomitant diseases affecting the joint; open wound or ulcer; use of anticoagulants or altered bleeding time; intra-articular injection or arthroscopy less than 6 months; and patients undergoing subtalar arthrodesis and, therefore, they did not participate in the initial study with a follow-up of 6 months after intra-articular injections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Patients are expected to have increased pain and reduced function, after 3 years of intra-articular injection compared to pre-treatment values, accessed through the Visual Analog Pain Scale (VAS) and the American Orthopedic foot and ankle society Ankle-Hindfoot Scale (AOFAS), respectively, especially in the group submitted to intra-articular injection of corticoid in relation to the groups that received injection of hyaluronic acid alone or associated with corticoid;Outcome found 1: Patients in the AH group had less pain, accessed by a lower median VAS score after three years in relation to pre-treatment values ??(7.0 and 8.5, respectively). The patients in the C group and the AH+C group, after three years, presented pain equivalent to the pre-treatment period, observed through equal medians before and after the intra-articular injection procedure (7.0 and 7.0 respectively for both groups). In addition, an increase in the function of patients in the AH group was observed after three years in relation to pre-treatment values, accessed by the median of the AOFAS score (59.50 and 53.00, respectively), while a decrease in function was observed in the group C (50.00 and 83.50, respectively) and also in the AH+C group (69.00 and 73.00, respectively) | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: It is expected to monitor the evolution of the disease, which is faster in the group of patients who received intra-articular injection of corticosteroids compared to those who received hyaluronic acid alone or combined with corticosteroids. This evolution will be evaluated through the degree of osteoarthritis according to the Kellgren and Lawrence classification. Accessed based on radiographs of the feet pre-intra-articular infiltration and three years after the procedure, in anteroposterior and lateral orthostatic and oblique Broden views;Outcome found 2: It was observed that the number of cases in which there was an increase in the degree of osteoarthritis was higher in the group of patients treated with corticosteroids (70%) compared to patients treated with hyaluronic acid alone (44.4%) or combined with corticosteroids (33.3%);Expected outcome 3: It is expected that the rate of arthrodesis will be higher in the group of patients who received intra-articular injection of corticoid compared to those who received hyaluronic acid alone or combined with corticoid. This rate is calculated by dividing the number of participants who underwent arthrodesis by the number of participants who did not undergo arthrodesis during the study time period;Outcome found 3: It was observed that, after three years of intra-articular infiltration, the group of patients who received corticosteroids had a higher rate of arthrodesis (33.3%) compared to the groups who received hyaluronic acid alone (23.1%) and combined with corticosteroids (15.4%) | — |
Countries
Brazil
Contacts
Public ContactFernanda Gomes
Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad
Outcome results
None listed