An interventional study of Accelerated Rehabilitation plan in Hallux Valgus and Bunion, sponsored by North District Hospital. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-24.
Sponsored by North District Hospital · Not applicable, Interventional, and Treatment
Investigate the optimal timing for weight bearing after Hallux Valgus surgery. Hypothesis: Early weight bearing does not affect outcome after the Endoscopic Distal Soft Tissue Procedure for Hallux Valgus Correction.
Introduction:
Hypothesis:
Early weight bearing (at 2 weeks post-op) does not affect outcome after the Endoscopic Distal Soft Tissue Procedure for Hallux Valgus correction
Trial Design:
Study Setting:
Exclusion Criteria:
Follow existing rehabilitation protocol of Non-weight bearing walking for 6 weeks followed by heel walking for 6 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation
Accelerated rehabilitation protocol of non-weight bearing walking for 2 weeks followed by heel walking for 10 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation
Other: Accelerated Rehabilitation plan
early weight bearing after surgery
Hallux Valgus Angle as a Measure of the Radiological Changes
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. A larger angle represents the more severe condition. This is the angle between the 1st metatarsal and the proximal phalanx.
Time frame: 0, 12, 26 weeks post-surgery
Inter-metatarsal Angle as a Measure of the Radiological Changes
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. A larger angle represents the more severe condition. This is measure using the bisecting line between the 1st metatarsal and the 2nd metatarsal.
Time frame: 0, 12, 26 weeks post-surgery
Radiological Changes (Tibial Sesamoid Position)
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. 4 represents the most neutral position. bigger difference from 4 means more severe condition. This a score from 0-7.
Time frame: 0, 12, 26 weeks post-surgery
Foot Function (FAOS Symptoms)
Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: 0, 12, 26 week post-surgery
Foot Function (FAOS Pain)
Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: 0, 12, 26 week post-surgery
Foot Function (FAOS ADL)
Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: 0, 12, 26 week post-surgery
Foot Function (FAOS Sport)
Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: 0, 12, 26 week post-surgery
Foot Function (FAOS QoL)
Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: 0, 12, 26 week post-surgery
| Milestone | Control Rehab | Accelerated Rehab |
|---|---|---|
| Started | 29 | 24 |
| Completed | 29 | 21 |
| Not completed | 0 | 3 |
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. A larger angle represents the more severe condition. This is the angle between the 1st metatarsal and the proximal phalanx.
| degrees | Control Rehab | Accelerated Rehab |
|---|---|---|
| 0 week | 35.6 ± 7.1 | 37.4 ± 8.0 |
| 12 week | 8.8 ± 5.2 | 7.2 ± 4.8 |
| 26 week | 11.6 ± 7.6 | 10.5 ± 6.2 |
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. A larger angle represents the more severe condition. This is measure using the bisecting line between the 1st metatarsal and the 2nd metatarsal.
| degrees | Control Rehab | Accelerated Rehab |
|---|---|---|
| 0 week | 14.0 ± 3.0 | 16.4 ± 3.7 |
| 12 week | 6.2 ± 1.9 | 7.2 ± 2.2 |
| 26 week | 7.7 ± 2.7 | 7.3 ± 2.4 |
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. 4 represents the most neutral position. bigger difference from 4 means more severe condition. This a score from 0-7.
| units on a scale | Control Rehab | Accelerated Rehab |
|---|---|---|
| 0 week | 5.55 ± 1.2 | 5.6 ± 1.1 |
| 12 week | 2.6 ± 1.2 | 3.0 ± 0.9 |
| 26 week | 2.9 ± 1.3 | 3.0 ± 1.0 |
Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
| score on a scale | Control 6-wk NWB | Early 2 Week NWB |
|---|---|---|
| 0 week | 58.3 ± 26.1 | 47.5 ± 23.9 |
| 12 week | 62.1 ± 16.1 | 76.9 ± 13.6 |
| 26 week | 81.9 ± 11.8 | 80.5 ± 15.6 |
Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
| score on a scale | Control 6-wk NWB | Early 2 Week NWB |
|---|---|---|
| 0 week | 44 ± 23.8 | 47.5 ± 28.8 |
| 12 week | 66.4 ± 19.3 | 78.6 ± 11.4 |
| 26 week | 82.2 ± 15.6 | 85.5 ± 12.9 |
Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
| score on a scale | Control 6-wk NWB | Early 2 Week NWB |
|---|---|---|
| 0 week | 59.7 ± 29.4 | 53.0 ± 25.6 |
| 12 week | 61.4 ± 17.3 | 81.4 ± 7.6 |
| 26 week | 84.3 ± 10.6 | 86.0 ± 8.2 |
Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
| score on a scale | Control 6-wk NWB | Early 2 Week NWB |
|---|---|---|
| 0 week | 52.1 ± 29.7 | 39.8 ± 26.7 |
| 12 week | NA ± NA | NA ± NA |
| 26 week | 76.7 ± 15.7 | 77.6 ± 13.7 |
Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
| score on a scale | Control 6-wk NWB | Early 2 Week NWB |
|---|---|---|
| 0 week | 41.2 ± 30.2 | 31.1 ± 23.6 |
| 12 week | 49.1 ± 20.4 | 72.6 ± 20.7 |
| 26 week | 82.4 ± 11.2 | 81.4 ± 14.9 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Rehab | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Accelerated Rehab | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | Control Rehab | Accelerated Rehab | Total |
|---|---|---|---|
| Median | 60 (25 to 71) | 60 (25 to 71) | 60 (25 to 71) |
| Sex: Female, Male(Participants) | Control Rehab | Accelerated Rehab | Total |
|---|---|---|---|
| Female | 26 | 19 | 45 |
| Male | 3 | 2 | 5 |
| Race and Ethnicity Not Collected(Participants) | Control Rehab | Accelerated Rehab | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Control Rehab | Accelerated Rehab | Total |
|---|---|---|---|
| Hong Kong | 29 | 21 | 50 |
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North District Hospital