Walking Aids in the Management of Hip Osteoarthritis

• ClinicalTrials.gov Identifier: NCT00506714
• Recruitment Status: Completed
• First Posted: July 25, 2007
• Results First Posted: September 28, 2012
• Last Update Posted: October 4, 2012
• Sponsor: Arthritis Foundation
• Information provided by (Responsible Party): Meika A. Fang, MD, Arthritis Foundation

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Osteoarthritis
• Intervention: Device: single point cane
• Enrollment: 26

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Healthy adults	Adults with symptomatic hip osteoarthritis
Period Title: Overall Study
Started	13	13
Completed	13	13
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Group 1	Group 2	Total
Arm/Group Description		Healthy adults	Adults with symptomatic hip osteoarthritis	Total of all reporting groups
Overall Number of Baseline Participants		13	13	26
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants	13 participants	26 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	6 46.2%	5 38.5%	11 42.3%
	>=65 years	7 53.8%	8 61.5%	15 57.7%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	13 participants	13 participants	26 participants
		65 (4.4)	67 (5.9)	66 (5.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants	13 participants	26 participants
	Female	2 15.4%	2 15.4%	4 15.4%
	Male	11 84.6%	11 84.6%	22 84.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	13 participants	13 participants	26 participants
		13	13	26

Outcome Measures

1. Primary Outcome

Title	Gait Velocity
Description	[Not Specified]
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Analysis was per protocol

Arm/Group Title	Group 1	Group 2
Arm/Group Description:	Healthy adults walking without a cane at baseline	Adults with symptomatic hip osteoarthritis walking without a cane at baseline
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation); Unit of Measure: cm/s
	107.5 (14.3)	79.7 (9.9)

2. Secondary Outcome

Title	Gait Velocity With a Cane in Hip OA Subjects
Description	Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Analysis was per protocol

Arm/Group Title	Group 2
Arm/Group Description:	Adults with symptomatic hip osteoarthritis walking with a cane at baseline
Overall Number of Participants Analyzed	13
Mean (Standard Deviation); Unit of Measure: cm/s
	68.7 (15.4)

3. Secondary Outcome

Title	Gait Velocity
Description	Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis was per protocol

Arm/Group Title	Group 2
Arm/Group Description:	Adults with symptomatic hip osteoarthritis after four weeks of cane use
Overall Number of Participants Analyzed	13
Mean (Standard Deviation); Unit of Measure: cm/s
	74.5 (14.2)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Group 1	Group 2
Arm/Group Description	Healthy adults	Adults with symptomatic hip osteoarthritis
All-Cause Mortality
	Group 1	Group 2
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Group 1	Group 2
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/13 (0.00%)	0/13 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Group 1	Group 2
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Meika A. Fang, MD
• Organization: Arthritis Foundation
• Phone: 310-478-3711 ext 84503
• EMail: meika.fang@va.gov

• Responsible Party: Meika A. Fang, MD, Arthritis Foundation
• ClinicalTrials.gov Identifier: NCT00506714
• Other Study ID Numbers: 2007-030430
• First Submitted: July 20, 2007
• First Posted: July 25, 2007
• Results First Submitted: February 6, 2012
• Results First Posted: September 28, 2012
• Last Update Posted: October 4, 2012