Trial Outcomes & Findings for Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis (NCT NCT00124462)

Results Overview

The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2017-06-29

Participant Flow

Subjects will be recruited from: 1) various different forms of public media including Boston Globe, Baystate Banner. 2) BMC patients referred from colleagues in the rheumatology and orthopedic sections. 3) individuals already recruited for other clinical trials with consent forms that included permission to call subjects for other studies)

Participant milestones

Participant milestones
Measure	Realignment to Placebo Realignment/Experimental Knee Brace and Shoe Insert- A valgus brace, customized functional orthodic for neutral foot position and motion control footwear. Placebo/Control Knee brace and Shoe Insert- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole	Placebo to Realignment Placebo/Control Knee brace and Shoe Insert- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole. Realignment/Experimental Knee Brace and Shoe Insert- A valgus brace, customized functional orthodic for neutral foot position and motion control footwear.
Overall Study STARTED	40	40
Overall Study COMPLETED	29	27
Overall Study NOT COMPLETED	11	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Realignment to Placebo Realignment/Experimental Knee Brace and Shoe Insert- A valgus brace, customized functional orthodic for neutral foot position and motion control footwear. Placebo/Control Knee brace and Shoe Insert- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole	Placebo to Realignment Placebo/Control Knee brace and Shoe Insert- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole. Realignment/Experimental Knee Brace and Shoe Insert- A valgus brace, customized functional orthodic for neutral foot position and motion control footwear.
Overall Study Lost to Follow-up	3	3
Overall Study Physician Decision	3	4
Overall Study Withdrawal by Subject	4	5
Overall Study Device fitting, n=2, other hlth issues	1	1

Baseline Characteristics

Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Realignment to Placebo n=40 Participants Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole	Placebo to Realignment n=40 Participants Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole. Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear	Total n=80 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 10.8 • n=5 Participants	60 years STANDARD_DEVIATION 13.1 • n=7 Participants	62 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
BMI	32.7 kg/m2 STANDARD_DEVIATION 8.4 • n=5 Participants	34.7 kg/m2 STANDARD_DEVIATION 10.8 • n=7 Participants	33.6 kg/m2 STANDARD_DEVIATION 9.4 • n=5 Participants
WOMAC pain score	9.2 units on a scale STANDARD_DEVIATION 3.4 • n=5 Participants	9.1 units on a scale STANDARD_DEVIATION 3.4 • n=7 Participants	9.15 units on a scale STANDARD_DEVIATION 3.4 • n=5 Participants
WOMAC function score	33.3 units on a scale STANDARD_DEVIATION 11.8 • n=5 Participants	34.6 units on a scale STANDARD_DEVIATION 10.3 • n=7 Participants	33.9 units on a scale STANDARD_DEVIATION 11.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.

Outcome measures

Outcome measures
Measure	Realignment to Placebo n=29 Participants Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole	Placebo to Realignment n=27 Participants Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole. Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
Mean Change WOMAC Pain Scale (Most Symptomatic Treated Knee)	-2.2 units on a scale change from baseline Standard Deviation 3.3	-1.7 units on a scale change from baseline Standard Deviation 3.8

PRIMARY outcome

Timeframe: Baseline and 12 weeks

The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions. Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.

Outcome measures

Outcome measures
Measure	Realignment to Placebo n=29 Participants Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole	Placebo to Realignment n=27 Participants Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole. Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
Change in WOMAC Function Scale (Most Symptomatic Treated Knee)	-5.1 units on a scale change from baseline Standard Deviation 12.1	-4.6 units on a scale change from baseline Standard Deviation 9.6

Adverse Events

Realignment to Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo to Realignment

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

ClinicalTrials.gov Administrator

Boston Univeristy

Phone: 617 638 8862

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place