Trial Outcomes & Findings for Timing of Weight Bearing After Hallux Valgus Surgery (NCT NCT03340415)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

0, 12, 26 weeks post-surgery

Results posted on

2021-03-24

Participant Flow

2 lost to follow-up. power analysis only required 40 participants.

Participant milestones

Participant milestones
Measure	Control Rehab 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 Rehab 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 Accelerated Rehabilitation plan: early weight bearing after surgery
Overall Study STARTED	29	24
Overall Study COMPLETED	29	21
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Rehab n=29 Participants 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 Rehab n=21 Participants 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 Accelerated Rehabilitation plan: early weight bearing after surgery	Total n=50 Participants Total of all reporting groups
Region of Enrollment Hong Kong	29 participants n=29 Participants	21 participants n=21 Participants	50 participants n=50 Participants
Age, Continuous	60 years n=29 Participants	60 years n=21 Participants	60 years n=50 Participants
Sex: Female, Male Female	26 Participants n=29 Participants	19 Participants n=21 Participants	45 Participants n=50 Participants
Sex: Female, Male Male	3 Participants n=29 Participants	2 Participants n=21 Participants	5 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Rehab n=29 Participants 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 Rehab n=21 Participants 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 Accelerated Rehabilitation plan: early weight bearing after surgery
Hallux Valgus Angle as a Measure of the Radiological Changes 0 week	35.6 degrees Standard Deviation 7.1	37.4 degrees Standard Deviation 8.0
Hallux Valgus Angle as a Measure of the Radiological Changes 12 week	8.8 degrees Standard Deviation 5.2	7.2 degrees Standard Deviation 4.8
Hallux Valgus Angle as a Measure of the Radiological Changes 26 week	11.6 degrees Standard Deviation 7.6	10.5 degrees Standard Deviation 6.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Rehab n=29 Participants 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 Rehab n=21 Participants 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 Accelerated Rehabilitation plan: early weight bearing after surgery
Inter-metatarsal Angle as a Measure of the Radiological Changes 0 week	14.0 degrees Standard Deviation 3.0	16.4 degrees Standard Deviation 3.7
Inter-metatarsal Angle as a Measure of the Radiological Changes 12 week	6.2 degrees Standard Deviation 1.9	7.2 degrees Standard Deviation 2.2
Inter-metatarsal Angle as a Measure of the Radiological Changes 26 week	7.7 degrees Standard Deviation 2.7	7.3 degrees Standard Deviation 2.4

PRIMARY outcome

Timeframe: 0, 12, 26 weeks post-surgery

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.