Trial Outcomes & Findings for Walking Aids in the Management of Hip Osteoarthritis (NCT NCT00506714)

NCT ID: NCT00506714

Last Updated: 2012-10-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2012-10-04

Participant Flow

Participant milestones

Measure	Group 1 Healthy adults	Group 2 Adults with symptomatic hip osteoarthritis
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Walking Aids in the Management of Hip Osteoarthritis

Baseline characteristics by cohort

Measure	Group 1 n=13 Participants Healthy adults	Group 2 n=13 Participants Adults with symptomatic hip osteoarthritis	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Age Continuous	65 years STANDARD_DEVIATION 4.4 • n=5 Participants	67 years STANDARD_DEVIATION 5.9 • n=7 Participants	66 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Analysis was per protocol

Outcome measures

Measure	Group 1 n=13 Participants Healthy adults walking without a cane at baseline	Group 2 n=13 Participants Adults with symptomatic hip osteoarthritis walking without a cane at baseline
Gait Velocity	107.5 cm/s Standard Deviation 14.3	79.7 cm/s Standard Deviation 9.9

SECONDARY outcome

Timeframe: Baseline

Population: Analysis was per protocol

Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.

Outcome measures

Measure	Group 1 n=13 Participants Healthy adults walking without a cane at baseline	Group 2 Adults with symptomatic hip osteoarthritis walking without a cane at baseline
Gait Velocity With a Cane in Hip OA Subjects	68.7 cm/s Standard Deviation 15.4	—

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis was per protocol

Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use

Outcome measures

Measure	Group 1 n=13 Participants Healthy adults walking without a cane at baseline	Group 2 Adults with symptomatic hip osteoarthritis walking without a cane at baseline
Gait Velocity	74.5 cm/s Standard Deviation 14.2	—

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Meika A. Fang, MD

Arthritis Foundation

Phone: 310-478-3711

Email: meika.fang@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place