Abstract
Background
Growing evidence supports a shift from inpatient to outpatient surgical treatment for ankle fractures. The primary aim of this study was to investigate the effect of inpatient versus outpatient surgery of ankle fractures on patient-reported outcome utilizing the Foot and Ankle Outcome Score (FAOS) at 12 weeks following surgery. Secondary aims were to report patients’ satisfaction, adverse events, pain, physical function, and bone healing between inpatient and outpatient treatment.
Patients and Methods
The study design was a non-inferiority randomized controlled, non-blinded trial with a two-groups. Patients were randomized 1:1 to outpatient or inpatient surgical treatment. The primary outcome was the FAOS at 12 weeks. Secondary outcomes included patients’ satisfaction, health-related quality of life, intensity of pain, bone union, and adverse events.
Results
A total of 44 patients were randomized to inpatient surgery and 42 patients to outpatient surgery. The final follow-up at 12 weeks following surgery was completed by 69 patients (80 %). The mean age of patients was 49.2 (SD 16.9), ranging from 18 to 80. Female sex represented 44 % of patients. The primary analysis revealed no statistically significant difference in FAOS subscale scores between inpatient and outpatient surgery at the 12-week follow-up Adjusted mean difference: Pain: −0.8 (95 % CI −10.7–9.0); Symptoms: 2.7 (95 % CI −6.9–12.5); ADL: −4.7 (95 % CI −13.6–4.3); Sport/Rec: 2.9 (95 % CI −15.2–9.3); and QOL: −0.7 (95 % CI −11.8–10.3). Comparable results were observed for secondary outcomes.
Conclusion
This study showed no statistical nor clinically significant difference in FAOS subscale scores between inpatient and outpatient surgery for ankle fractures 12 weeks following surgery. Furthermore, patients’ satisfaction and adverse events were comparable between inpatient and outpatient surgery 12 weeks following treatment. Results indicated that outpatient surgery for ankle fractures is highly feasible for selected patients and may be considered as routine for clinical practice.
1
Introduction
Patients presenting with ankle fractures are very common in the orthopedic emergency department , . The incidence is reported to be 169–174 per 100,000 per year with peaks in younger males and older females . Shifting demographics toward an elderly population and increase in participation in sports is anticipated to increase the incidence of ankle fractures in the future ,, .
The treatment of ankle fractures predominantly depends on fracture stability and patients’ co-morbidity . Surgical treatment is recommended for about 30 % of patients presenting with unstable ankle fractures , . The aim of the surgical treatment is to restore the anatomical function of the ankle joint by repositioning and fixation of the fracture with screws, plates, or pins.
Growing evidence supports a shift from inpatient to outpatient surgical treatment of several orthopedic procedures ,,,,,,,,,, . Earlier recommendations of inpatient treatment are largely based on the hypothesis that monitoring of postoperative pain, soft tissue conditions, and early mobilization are best achieved during inpatient treatment ,, . A recent systematic review found that outpatient procedures seem to be less expensive and a safe alternative to hospitalization for a mixed group of orthopaedic patients who are at low risk of complications and require orthopaedic procedures that do not necessitate hospital-level care .
A retrospective analysis of 256 surgically treated ankle fracture patients showed that outpatient surgical treatment of isolated ankle fractures is a safe and resource-efficient concept and was not associated with an increase in complication rates . Several other studies have reported that outpatient surgery of ankle fractures is safe and less expensive ,,, . However, existing literature is of an observational or retrospective nature, and lacks randomized controlled trials comparing inpatient and outpatient surgical treatment of ankle fractures. Completing a randomized controlled trial investigating inpatient versus outpatient surgical treatment for ankle fractures including information of pain, patient-reported outcomes, patient satisfaction, and adverse events may facilitate an evidence-based shift from inpatient to outpatient treatment and will provide evidence to guide future recommendations in the treatment of this large and increasing patient group.
The primary aim of this study was to investigate the effect of inpatient versus outpatient surgical treatment of ankle fractures on patient-reported outcome (utilizing the Foot and Ankle Outcome Score; (FAOS) at 12 weeks following surgery. Secondary aims were to report patients’ satisfaction, adverse events, pain, physical function, and bone healing between inpatient and outpatient treatment. We hypothesize that patients treated in outpatient care have a FOAS of less than 14 points worse than patients treated in inpatient care.
2
Patients and methods
2.1
Design
This study is the primary trial report on the Outpatient Versus Inpatient Surgery for Ankle Fractures (OVISAF) trial. The study design was a non-inferiority randomized controlled, non-blinded trial with a two-groups design. The trial protocol, which includes detailed descriptions of study procedures, methods, and a statistical analysis plan, is available as open access and was submitted for publication before the last patient was included .
The study was approved by the Committee for Science Ethics for Northern Denmark (N-20220012) and performed in accordance with the principles of the Helsinki Declaration. The study was pre-registered on Clinicaltrials.gov (NCT05389436). The trial was reported using the CONSORT guidelines .
2.1.1
Participants
Patients were recruited by consecutive sampling from the Department of Orthopedic Surgery at Aalborg University Hospital, Denmark. Included were adult patients (age ≥18 years), ankle fractures necessitating surgical treatment, ankle fracture preoperatively satisfactorily reduced in a lower leg cast, and patients able to ambulate with a walking aid and take care of themselves (possibly with the help of relatives) at home.
Excluded were patients with impaired physical, mental, or social function, not reading or understanding spoken Danish, or who did not wish to participate. Furthermore, patients were excluded if presenting with concurrent major fracture to the lower extremity (ipsi- and/or contralateral), pathologic fracture, ASA score 3 or higher, pregnancy, open fracture, or infectious disease requiring isolation.
2.1.2
Randomization
Following the assessment of patients’ basic characteristics and informed consent, patients were randomized 1:1 to outpatient or inpatient treatment. An independent researcher prepared the randomization schedule in STATA and the web-based software REDCap was used for the digital blinded allocation sequence.
2.1.3
Interventions
When randomized to outpatient treatment the patient was discharged from the emergency room with written information on the expected treatment plan. Surgical treatment was conducted at our outpatient ward. At the end of the surgical procedure perineurial elastomeric pain catheters were placed at the saphenous and sciatic popliteal areas. When the patient was alert and mobilized, without weightbearing, they were discharged. The patient was instructed to remove the perineurial catheters when they were empty.
When randomized to inpatient treatment the patient was transferred to the inpatient ward. Until surgery a regime of elevation for the casted ankle was observed. Once anesthetized, peripheral single shot nerve blocks were administered perineurally in the saphenous and sciatic popliteal areas. These patients did not receive perineurial pain catheters. The patient was discharged when mobilized and the pain was manageable with oral pain medication.
The surgical procedure was identical regardless of randomized to inpatient or outpatient treatment.
2.1.4
Outcomes
Outcomes were assessed by interview 2 days following surgery and after 2, 6, and 12 weeks at the orthopedic outpatient clinic.
Baseline characteristics including age, gender, side of fracture, and fracture classification (ICD-10/AAO classification) . Furthermore, height, weight, smoking status, diabetic disease, peripheral nervus and/or vessel disease, and ASA score were registered.
2.2
Primary outcome and endpoint
The primary outcome was the FAOS at 12 weeks . The FOAS is a patient-reported body region-specific questionnaire consisting of five subscales: pain, symptoms, activities of daily living (ADL), function in sport and recreation (Sport/Rec), and foot- and ankle-related quality of life (QOL) . The patients were asked to recall the past week when completing the questionnaire. A score of 100 indicates no symptoms, 0 points indicate extreme symptoms .
The FAOS has previously been validated to assess outcome following ankle fractures , . An endpoint of 12 weeks was chosen due to the fact that the difference between inpatient and outpatient treatment was expected to be present during the first weeks following fracture.
2.3
Secondary outcomes
Pain intensity was evaluated by interview at 2 days and 2, 6, and 12 weeks following surgery. Pain intensity was measured for worst pain during the last 24 hours and resting pain, on a 10 cm visual analogue scale (VAS) with the endpoints “no pain” and “maximal pain.”
Bone union was assessed with standard X-rays at 6 and 12 weeks. Healing was categorized as 1) no visible callus/visible fracture lines on all views: no healing; 2) callus visible on 1 or 2 cortices/fracture line visible on 1 or 2 views: some healing; 3) callus visible on 3 or 4 cortices/no visible fracture line: healed , .
Health-related quality of life was measured using the European Quality of Life 5 Dimension Questionnaire, 5 Level version (EQ5D-5L) at 2, 6, and 12 weeks. EQ5D-5L is a standardized generic health-related patient-reported outcome measure. An index of 1.0 indicates full health, 0 denotes death, and −0.59 denotes a condition worse than death .
Patients’ activity level was measured using the Tegner Activity Scale (TAS). At 2 weeks the patient completed the pre-injury score and at 12 weeks the score was recorded for the actual date. The TAS is designed for pre-injury and post-injury assessment of the patient’s activity level . A score of 10 indicates an activity level equivalent to professional sports and a score of 0 retirement or sick leave due to injury .
Patients’ satisfactions were evaluated by interview at 2 and 12 weeks based on two questions:
-
1.
Based on your experience, how likely is it that you would choose this treatment again?
-
2.
Based on your experience, how likely is it that you would recommend this treatment to friends/relatives?
Possible answers were: very likely, likely, neither/nor, unlikely, and very unlikely. The patients could also elaborate in free text. The questions intended to examine the patients’ combined experience with participating and elaborate on their reflections with respect to level of pain, personal mobility, transportation time, waiting time to surgery, and information received.
The Patient-Acceptable Symptom State (PASS) was included by a single question at 12 weeks: “Based on your current symptoms, would you seek professional medical treatment if you were not part of this study?”
2.4
Adverse events
Adverse events were recorded throughout the study. Adverse events were defined as any negative or unwanted reaction to both treatment arms which could affect treatment or outcome. Adverse events were categorized as infection (skin only), deep infection (involving plates/screws), deep venous thromboembolism (DVT), failure of osteosynthesis, prolonged skin healing, compartment syndrome, or other.
2.4.1
Statistics
The reported FAOS minimal clinically important difference for ankle fractures of 14 was used as non-inferiority margin . Based on an SD of 21, a ratio of 1:1, and an allowable difference of 0, a sample size of 86 patients was established to achieve a power of 90 %, with a one-sided significance level of 5 %, allowing for 10 % drop-out .
A linear mixed regression model was used to estimating the mean difference in the primary and secondary outcomes. The model was adjusted by age and gender. Patients were considered a random effect, while time of follow-up, inpatient versus outpatient surgery, and interaction were treated as fixed effect variables . The analysis was performed according to the intention-to-treat principle and per-protocol analysis was performed to analyse sensitivity.
The between-group risk of dichotomous variables was calculated as a risk difference.
3
Results
During the study period a total of 403 patients were admitted with an ankle fracture necessitating surgical treatment. A total of 44 patients were randomized to inpatient surgery and 42 patients to outpatient surgery. The final follow-up at 12 weeks following surgery was completed by 69 patients (80 %) ( Fig. 1 ). Six patients crossed over from outpatient treatment to inpatient treatment; before surgery crossover was observed in four patients, after surgery cross over was observed in two patients ( Table 5 ).
CONSORT flow of the study. Captions: n = number.
The mean age of patients was 49.2 years (SD 16.9), ranging from 18 to 80. Female sex represented 44 % of patients. Baseline characteristics divided by inpatient and outpatient surgery are presented in Table 1 .
Table 1
Patients baseline charrecteristics precented by inpatient and outpatient surgery.
| Inpatient | Outpatient | |
|---|---|---|
| Number of patients randomized, n (%) | 44 | 42 |
| Age at time of fracture, mean (range) | 47.8(16.9) | 50.6(16.8) |
| Sex, n (%) female | 18(41 %) | 20(48 %) |
| Height cm, mean (SD) | 172.7(9.1) | 176.2(8.7) |
| Mass kg, mean (SD | 83.4(14.6) | 86.2(14.2) |
| Body mass index kg/m2, mean (SD) | 28.0(4.6) | 27.8(4.2) |
| Smoking, n (%) | 7(16 %) | 3(7 %) |
| Diabetes, n (%) | 3(7 %) | 3(7 %) |
| ASA-score, mean (SD) | 1.7(0.6) | 1.6(0.6) |
| ICD−10 classification: n (%) | ||
| DS82.5 | 2(5 %) | 4 (9 %) |
| DS82.6 | 3(7 %) | 4(9 %) |
| DS827A | 15(34 %) | 15(36 %) |
| DS82.7B | 21(48 %) | 17(40 %) |
| DS82.8B | 2(5 %) | 2(6 %) |
| DS82.8D | – | – |
| DS92.9 | 1(1 %) | – |
| Days from admission to surgery, mean(range) | 1.4(0−5) | 3.1(1-8) |
SD: standard deviation, n:number
3.1
Primary outcome
The primary analysis revealed no statistically significant difference in FAOS subscale scores between inpatient and outpatient surgery at the 12-week follow-up. Adjusted mean difference: Pain: −0.8 (95 % CI −10.7–9.0); Symptoms: 2.7 (95 % CI −6.9–12.5); ADL: −4.7 (95 % CI −13.6–4.3); Sport/Rec: 2.9 (95 % CI −15.2–9.3); and QOL: −0.7 (95 % CI −11.8–10.3) ( Table 2 ).
Table 2
Primary outcomes and between-group comparison.
| Outcomes | Follow-up time | Inpatient surgery, mean (95 % CI) | Outpatient surgery, mean (95 % CI) | Inpatient vs outpatient, crude mean difference (95 % CI) | Inpatient vs outpatient, adjusted mean difference (95 % CI) |
|---|---|---|---|---|---|
| FAOS Pain | 12 weeks | 68.7(61.9–75.4) | 69.8(62.7–76.9) | −1.1(−10.8–8.6) | −0.8(−10.7–9.0) |
| FAOS Symptoms | 12 weeks | 56.0(49.4–62.7) | 53.9(46.9–60.9) | 2.1(−7.5–11.8) | 2.7(−6.9–12.5) |
| FAOS ADL | 12 weeks | 77.3(71.3–83.3) | 81.9(75.5–88.3) | −4.6(−13.4–4.1) | −4.7(−13.6–4.3) |
| FAOS Sport/Rec | 12 weeks | 35.0(26.3–43.7) | 39.7(30.5–48.9) | −4.7(−17.3–8.0) | −2.9(−15.2–9.3) |
| FAOS QOL | 12 weeks | 45.8(38.4–53.3) | 46.9(39.0–54.7) | −1.0(−11.9–9.8) | −0.7(−11.8–10.3) |
3.2
Secondary outcomes
3.2.1
Health-related quality of life, EQ5D
No statistically significant difference in EQ5D index and VAS score between inpatient and outpatient treatment was observed at the 2-, 6-, and 12-week follow-up. Adjusted mean difference at 12 weeks: EQ5D index: −0.038 (95 % CI −0.097–0.021); EQ5D-VAS: 2.0 (95 % CI −7.7–11.8) ( Table 3 ).
Table 3
Secondary outcomes and between-group comparison.
| Outcomes | Follow-up time | Inpatient surgery, mean (95 % CI) | Outpatient surgery, mean (95 % CI) | Inpatient vs outpatient, crude mean difference (95 % CI) | Inpatient vs outpatient, adjusted mean difference (95 % CI) |
|---|---|---|---|---|---|
| Resting pain | 2 days | 3.0 (2.3–3.6) | 2.8(2.0–3.5) | 0.2(−0.8–1.2) | 0.2(−0.8–1.1) |
| 2 weeks | 1.7(1.1–2.4) | 1.8(1.3–2.5) | −0.1(−1.0–0.8) | −0.1(−1.0–0.8) | |
| 6 weeks | 1.1(0.6–1.6) | 1.1(0.5–1.6) | 0.1(−0.7–0.8) | 0.0(−0.7–0.8) | |
| 12 weeks | 1.5(0.9–2.1) | 1.2(0.6–1.8) | 0.3(−0.6–1.2) | 0.3(−0.5–1.2) | |
| Worst pain 24 h | 2 days | 5.9(5.1–6.7) | 5.3(4.4–6.3) | 0.5(−0.7–1.8) | 0.5(−0.8–1.7) |
| 2 weeks | 4.0(3.0–5.0) | 3.9(2.9–4.8) | 0.1(−1.3–1.6) | −0.1(−1.5–1.4) | |
| 6 weeks | 2.5(1.7–3.3) | 1.9(1.1–2.7) | 0.6(−0.5–1.7) | 0.6(−0.5–1.8) | |
| 12 weeks | 3.1(2.3–4.0) | 2.9(2.0–3.8) | 0.2(−1.0–1.5) | 0.1(−1.1–1.4) | |
| Eq5Dindex | 2 weeks | 0.466(0.377–0.555) | 0.472(0.390–0.553) | −0.006(−0.126–0.115) | −0.031(−0.152–0.091) |
| 6 weeks | 0.571(0.505–0.637) | 0.603(0.532–0.675) | −0.032(−0.129–0.065) | −0.029(−0.127–0.068) | |
| 12 weeks | 0.718(0.677–0.760) | 0.762(0.719–0.805) | −0.044(−0.103–0.016) | −0.038(−0.097–0.021) | |
| Eq5D-VAS | 2 weeks | 54.6(45.2–63.9) | 65.4(56.8–74.1) | −10.9(−23.7–1.9) | −13.2(−26.1–0.1) |
| 6 weeks | 66.3(59.9–72.6) | 70.4(63.6–77.2) | −4.2(−13.5–5.1) | −4.6(−14.0–4.9) | |
| 12 weeks | 72.5(65.8–79.2) | 70.7(63.8–77.6) | 1.8(−7.9–11.4) | 2.0(−7.7–11.8) |
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