18 and older, any sex, with Hallux Valgus and Bunion. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hallux Valgus Angle as a Measure of the Radiological ChangesPrimary· 0, 12, 26 weeks post-surgery
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.
0 week
Group
Value
95% CI
Control Rehab
35.6
± 7.1
Accelerated Rehab
37.4
± 8.0
12 week
Group
Value
95% CI
Control Rehab
8.8
± 5.2
Accelerated Rehab
7.2
± 4.8
26 week
Group
Value
95% CI
Control Rehab
11.6
± 7.6
Accelerated Rehab
10.5
± 6.2
Inter-metatarsal Angle as a Measure of the Radiological ChangesPrimary· 0, 12, 26 weeks post-surgery
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.
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.
0 week
Group
Value
95% CI
Control Rehab
5.55
± 1.2
Accelerated Rehab
5.6
± 1.1
12 week
Group
Value
95% CI
Control Rehab
2.6
± 1.2
Accelerated Rehab
3.0
± 0.9
26 week
Group
Value
95% CI
Control Rehab
2.9
± 1.3
Accelerated Rehab
3.0
± 1.0
Foot Function (FAOS Symptoms)Secondary· 0, 12, 26 week post-surgery
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.
0 week
Group
Value
95% CI
Control 6-wk NWB
58.3
± 26.1
Early 2 Week NWB
47.5
± 23.9
12 week
Group
Value
95% CI
Control 6-wk NWB
62.1
± 16.1
Early 2 Week NWB
76.9
± 13.6
26 week
Group
Value
95% CI
Control 6-wk NWB
81.9
± 11.8
Early 2 Week NWB
80.5
± 15.6
Foot Function (FAOS Pain)Secondary· 0, 12, 26 week post-surgery
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.
0 week
Group
Value
95% CI
Control 6-wk NWB
44
± 23.8
Early 2 Week NWB
47.5
± 28.8
12 week
Group
Value
95% CI
Control 6-wk NWB
66.4
± 19.3
Early 2 Week NWB
78.6
± 11.4
26 week
Group
Value
95% CI
Control 6-wk NWB
82.2
± 15.6
Early 2 Week NWB
85.5
± 12.9
Foot Function (FAOS ADL)Secondary· 0, 12, 26 week post-surgery
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.
0 week
Group
Value
95% CI
Control 6-wk NWB
59.7
± 29.4
Early 2 Week NWB
53.0
± 25.6
12 week
Group
Value
95% CI
Control 6-wk NWB
61.4
± 17.3
Early 2 Week NWB
81.4
± 7.6
26 week
Group
Value
95% CI
Control 6-wk NWB
84.3
± 10.6
Early 2 Week NWB
86.0
± 8.2
Foot Function (FAOS Sport)Secondary· 0, 12, 26 week post-surgery
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.
0 week
Group
Value
95% CI
Control 6-wk NWB
52.1
± 29.7
Early 2 Week NWB
39.8
± 26.7
12 week
Group
Value
95% CI
Control 6-wk NWB
NA
± NA
Early 2 Week NWB
NA
± NA
26 week
Group
Value
95% CI
Control 6-wk NWB
76.7
± 15.7
Early 2 Week NWB
77.6
± 13.7
Foot Function (FAOS QoL)Secondary· 0, 12, 26 week post-surgery
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.
0 week
Group
Value
95% CI
Control 6-wk NWB
41.2
± 30.2
Early 2 Week NWB
31.1
± 23.6
12 week
Group
Value
95% CI
Control 6-wk NWB
49.1
± 20.4
Early 2 Week NWB
72.6
± 20.7
26 week
Group
Value
95% CI
Control 6-wk NWB
82.4
± 11.2
Early 2 Week NWB
81.4
± 14.9
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by North District Hospital
Last refreshed: 24 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03340415.