Timing of Weight Bearing After Hallux Valgus Surgery

Conditions

Hallux Valgus and Bunion

Keywords

Hallux Valgus, Bunion, Post-operative, Rehabilitation, Weight Bearing Status

Brief summary

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.

Detailed description

Introduction: * Rehabilitation plans after hallux valgus/bunion surgery is varied * From a patient's perspective, full weight bearing is paramount for quality of life and return to work/study * No high-level study showing the optimal time to resume full weight bearing available 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: * Parallel group * Random allocation * Operating Surgeon blind to randomisation Study Setting: * General Regional Hospital * Single Centre

Related papers

No related papers found yet.

Interventions

OTHERAccelerated Rehabilitation plan

early weight bearing after surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

Surgeon blinded

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* All patients undergoing the EDSTP recruited

Exclusion criteria

* Cases requiring additional procedures (eg 2nd toe correction) * Mental incapacitation * Physical disability hindering rehabilitation (eg CVA, neurological disorder)

Design outcomes

Primary

Measure	Time frame	Description
Hallux Valgus Angle as a Measure of the Radiological Changes	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.
Inter-metatarsal Angle as a Measure of the Radiological Changes	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.
Radiological Changes (Tibial Sesamoid Position)	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.

Secondary

Measure	Time frame	Description
Foot Function (FAOS Sport)	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.
Foot Function (FAOS Symptoms)	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.
Foot Function (FAOS QoL)	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.
Foot Function (FAOS Pain)	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.
Foot Function (FAOS ADL)	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.

Countries

Hong Kong

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
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	29
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	21
Total	50

Baseline characteristics

Characteristic	Accelerated Rehab	Total	Control Rehab
Age, Continuous	60 years	60 years	60 years
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Hong Kong	21 participants	50 participants	29 participants
Sex: Female, Male Female	19 Participants	45 Participants	26 Participants
Sex: Female, Male Male	2 Participants	5 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 29	0 / 24
other Total, other adverse events	0 / 29	0 / 24
serious Total, serious adverse events	0 / 29	0 / 24

Outcome results

Primary

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Control Rehab	Hallux Valgus Angle as a Measure of the Radiological Changes	0 week	35.6 degrees	Standard Deviation 7.1
Control Rehab	Hallux Valgus Angle as a Measure of the Radiological Changes	12 week	8.8 degrees	Standard Deviation 5.2
Control Rehab	Hallux Valgus Angle as a Measure of the Radiological Changes	26 week	11.6 degrees	Standard Deviation 7.6
Accelerated Rehab	Hallux Valgus Angle as a Measure of the Radiological Changes	0 week	37.4 degrees	Standard Deviation 8
Accelerated Rehab	Hallux Valgus Angle as a Measure of the Radiological Changes	12 week	7.2 degrees	Standard Deviation 4.8
Accelerated Rehab	Hallux Valgus Angle as a Measure of the Radiological Changes	26 week	10.5 degrees	Standard Deviation 6.2

Primary

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Control Rehab	Inter-metatarsal Angle as a Measure of the Radiological Changes	0 week	14.0 degrees	Standard Deviation 3
Control Rehab	Inter-metatarsal Angle as a Measure of the Radiological Changes	12 week	6.2 degrees	Standard Deviation 1.9
Control Rehab	Inter-metatarsal Angle as a Measure of the Radiological Changes	26 week	7.7 degrees	Standard Deviation 2.7
Accelerated Rehab	Inter-metatarsal Angle as a Measure of the Radiological Changes	0 week	16.4 degrees	Standard Deviation 3.7
Accelerated Rehab	Inter-metatarsal Angle as a Measure of the Radiological Changes	12 week	7.2 degrees	Standard Deviation 2.2
Accelerated Rehab	Inter-metatarsal Angle as a Measure of the Radiological Changes	26 week	7.3 degrees	Standard Deviation 2.4

Primary

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Control Rehab	Radiological Changes (Tibial Sesamoid Position)	0 week	5.55 units on a scale	Standard Deviation 1.2
Control Rehab	Radiological Changes (Tibial Sesamoid Position)	12 week	2.6 units on a scale	Standard Deviation 1.2
Control Rehab	Radiological Changes (Tibial Sesamoid Position)	26 week	2.9 units on a scale	Standard Deviation 1.3
Accelerated Rehab	Radiological Changes (Tibial Sesamoid Position)	0 week	5.6 units on a scale	Standard Deviation 1.1
Accelerated Rehab	Radiological Changes (Tibial Sesamoid Position)	12 week	3.0 units on a scale	Standard Deviation 0.9
Accelerated Rehab	Radiological Changes (Tibial Sesamoid Position)	26 week	3.0 units on a scale	Standard Deviation 1

Secondary

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.