Efficacy Study of an Unloading Brace for Knee Osteoarthritis

• Sponsor: Andrews Research & Education Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT02150057
• Collaborator: BREG, Inc (Industry)
• Enrollment: 51
• Location: 1
• Arms: 2
• Duration (Months): 38.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to participate in this randomized study. Subjects will be assigned to either a Fusion Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on osteoarthritis knee pain and quality of life compared to those who do not receive bracing intervention.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee	Device: Breg Fusion Unloading Brace	N/A

Detailed Description

This investigation will recruit 72 subjects from the clinical population of the investigators with symptomatic unicompartmental osteoarthritis of the medial compartment of the knee who meet the inclusion criteria of the investigation. Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation:

1. Fusion Osteoarthritis Knee Brace

2. No brace group

Inclusion Criteria:

• Age 30-80.

• History of medial unicompartmental knee pain > 3 months duration (medial compartment only).

• Narrowing of medial joint space < one half of lateral compartment

• Varus deformity no greater than 80

• Mild to moderate limitation in Activities of Daily Living (ADL's) and/or recreational activities.

• Must read and understand English language and demonstrate the ability and willingness to follow the protocol and complete the questionnaires and diaries.

• Manual dexterity sufficient to perform all tasks required of study participants.

• Willingness to wear the brace a minimum of 4 hours per day.

Exclusion Criteria:

• Arthritides other than osteoarthritis.

• Previous high tibial osteotomy of the affected knee.

• Previous surgery of affected knee other than diagnostic arthroscopy with joint debridement, soft tissue reconstruction, menisectomy.

• Fixed flexion deformities / limitations >10 degrees as compared to the contralateral limb.

• Flexion limitation > 20 degrees.

• Significant soft tissue compromise preventing long-term brace use.

• Peripheral vascular disease or other neurovascular complaints

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation: Breg Fusion Osteoarthritis Knee Brace No brace group Both groups will be allowed to continue standard conservative treatment of osteoarthritis including anti-inflammatory medications, home exercises and joint supplements.Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation:Breg Fusion Osteoarthritis Knee Brace No brace group Both groups will be allowed to continue standard conservative treatment of osteoarthritis including anti-inflammatory medications, home exercises and joint supplements.
• Masking: Single (Care Provider)
• Masking Description: Two orthopedic surgeons will blindly grade the osteoarthritis and calculate the mechanical axis and knee angles. The two surgeons' measurements will be averaged. One surgeon's measurements will be repeated to determine intra-observer reliability.
• Primary Purpose: Prevention
• Official Title: Efficacy of Medial Compartment Unloading Brace Use for Osteoarthritis of the the Knee: A Prospective Randomized Study
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group This group receives no experimental bracing intervention in the study.
Active Comparator: Experimental Group This group will receive the Breg Fusion Osteoarthritis Knee Unloading Brace to wear for a determined amount of time per study protocol for the treatment of osteoarthritis pain.	Device: Breg Fusion Unloading Brace; This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.; Other Names: Breg Fusion Osteoarthritis Knee Unloading Brace

Outcome Measures

Primary Outcome Measures

1. Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score [Baseline, 6 month follow-up]

   The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered to collect patient reported outcomes as they relate to pain, function, and quality of life. The pain scale range is 0-10 with lower scores indicating less pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 30-80.

• History of medial unicompartmental knee pain > 3 months duration (medial compartment only).

• Narrowing of medial joint space < one half of lateral compartment

• Varus deformity no greater than 80

• Mild to moderate limitation in Activities of Daily Living (ADL's) and/or recreational activities.

• Must read and understand English language and demonstrate the ability and willingness to follow the protocol and complete the questionnaires and diaries.

• Manual dexterity sufficient to perform all tasks required of study participants.

• Willingness to wear the brace a minimum of 4 hours per day.

Exclusion Criteria:

• Arthritides other than osteoarthritis.

• Previous high tibial osteotomy of the affected knee.

• Previous surgery of affected knee other than diagnostic arthroscopy with joint debridement, soft tissue reconstruction, menisectomy.

• Fixed flexion deformities / limitations >10 degrees as compared to the contralateral limb.

• Flexion limitation > 20 degrees.

• Significant soft tissue compromise preventing long-term brace use.

• Peripheral vascular disease or other neurovascular complaints.

• Leg-length discrepancy > 2cm.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andrews Institute for Orthopaedics & Sports Medicine	Gulf Breeze	Florida	United States	32561

Sponsors and Collaborators

• Andrews Research & Education Foundation
• BREG, Inc

Investigators

• Principal Investigator: Roger Ostrander, MD, Andrews Institute for Orthopaedics & Sports Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• Barnes CL, Cawley PW, Hederman B. Effect of CounterForce brace on symptomatic relief in a group of patients with symptomatic unicompartmental osteoarthritis: a prospective 2-year investigation. Am J Orthop (Belle Mead NJ). 2002 Jul;31(7):396-401.
• Birmingham TB, Kramer JF, Kirkley A, Inglis JT, Spaulding SJ, Vandervoort AA. Knee bracing for medial compartment osteoarthritis: effects on proprioception and postural control. Rheumatology (Oxford). 2001 Mar;40(3):285-9.
• Buckwalter JA, Stanish WD, Rosier RN, Schenck RC Jr, Dennis DA, Coutts RD. The increasing need for nonoperative treatment of patients with osteoarthritis. Clin Orthop Relat Res. 2001 Apr;(385):36-45. Review.
• Cunningham LS, Kelsey JL. Epidemiology of musculoskeletal impairments and associated disability. Am J Public Health. 1984 Jun;74(6):574-9.
• Divine JG, Hewett TE. Valgus bracing for degenerative knee osteoarthritis: relieving pain, improving gait, and increasing activity. Phys Sportsmed. 2005 Feb;33(2):40-6. doi: 10.3810/psm.2005.02.48.
• Draper ER, Cable JM, Sanchez-Ballester J, Hunt N, Robinson JR, Strachan RK. Improvement in function after valgus bracing of the knee. An analysis of gait symmetry. J Bone Joint Surg Br. 2000 Sep;82(7):1001-5.
• Gabriel SE, Crowson CS, Campion ME, O'Fallon WM. Direct medical costs unique to people with arthritis. J Rheumatol. 1997 Apr;24(4):719-25.
• Gabriel SE, Crowson CS, O'Fallon WM. Costs of osteoarthritis: estimates from a geographically defined population. J Rheumatol Suppl. 1995 Feb;43:23-5.
• Giori NJ. Load-shifting brace treatment for osteoarthritis of the knee: a minimum 2 1/2-year follow-up study. J Rehabil Res Dev. 2004 Mar;41(2):187-94.
• Katsuragawa Y, Fukui N, Nakamura K. Change of bone mineral density with valgus knee bracing. Int Orthop. 1999;23(3):164-7.
• Kirkley A, Webster-Bogaert S, Litchfield R, Amendola A, MacDonald S, McCalden R, Fowler P. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am. 1999 Apr;81(4):539-48.
• Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998 May;41(5):778-99.
• Lethbridge-Cejku M, Tobin JD, Scott WW Jr, Reichle R, Plato CC, Hochberg MC. The relationship of age and gender to prevalence and pattern of radiographic changes of osteoarthritis of the knee: data from Caucasian participants in the Baltimore Longitudinal Study of Aging. Aging (Milano). 1994 Oct;6(5):353-7.
• Matsuno H, Kadowaki KM, Tsuji H. Generation II knee bracing for severe medial compartment osteoarthritis of the knee. Arch Phys Med Rehabil. 1997 Jul;78(7):745-9.
• Pollo FE, Otis JC, Backus SI, Warren RF, Wickiewicz TL. Reduction of medial compartment loads with valgus bracing of the osteoarthritic knee. Am J Sports Med. 2002 May-Jun;30(3):414-21.
• Pollo FE. Bracing and heel wedging for unicompartmental osteoarthritis of the knee. Am J Knee Surg. 1998 Winter;11(1):47-50. Review.
• Rao JK, Mihaliak K, Kroenke K, Bradley J, Tierney WM, Weinberger M. Use of complementary therapies for arthritis among patients of rheumatologists. Ann Intern Med. 1999 Sep 21;131(6):409-16.

• Responsible Party: Andrews Research & Education Foundation
• ClinicalTrials.gov Identifier: NCT02150057
• Other Study ID Numbers: BREG72609
• First Posted: May 29, 2014
• Last Update Posted: Oct 22, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Andrews Research & Education Foundation: knee osteoarthritis unicompartmental unloading brace
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	This group receives no experimental bracing intervention in the study.	Breg Fusion Osteoarthritis knee unloading brace Fusion Osteoarthritis Knee Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
Period Title: Overall Study
STARTED	25	26
COMPLETED	19	22
NOT COMPLETED	6	4

Baseline Characteristics

Arm/Group Title	Control Group	Experimental Group	Total
Arm/Group Description	This group receives no experimental bracing intervention in the study.	This group is assigned to wear the BREG Fusion Osteoarthritis Unloading Brace and report pain and quality of life by completion of a pain diary and related questionnaires.	Total of all reporting groups
Overall Participants	19	22	41
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	11 57.9%	11 50%	22 53.7%
>=65 years	8 42.1%	11 50%	19 46.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.13 (6.11)	67.8 (9.68)	65.9 (8.12)
Sex: Female, Male (Count of Participants)
Female	8 42.1%	7 31.8%	15 36.6%
Male	11 57.9%	15 68.2%	26 63.4%
Region of Enrollment (participants) [Number]
United States	19 100%	22 100%	41 100%

Outcome Measures

1. Primary Outcome

Title	Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
Description	The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered to collect patient reported outcomes as they relate to pain, function, and quality of life. The pain scale range is 0-10 with lower scores indicating less pain.
Time Frame	Baseline, 6 month follow-up

Outcome Measure Data

Analysis Population Description

Only 19 patients in the control group completed the study. Only 22 patients in the experimental group completed the study.

Arm/Group Title	Control Group	Experimental Group
Arm/Group Description	This group receives no experimental bracing intervention in the study.	This group will receive the BREG Fusion Osteoarthritis Knee Unloading Brace to wear for a determined amount of time per study protocol for the treatment of osteoarthritis pain. BREG Fusion Unloading Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
Measure Participants	19	22
Baseline Visit	2.92 (0.57)	2.86 (0.52)
6 Month Visit	3.03 (0.65)	2.67 (0.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Experimental Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	Patients were monitored for adverse events for the 6 month duration that they were enrolled in the study.
Adverse Event Reporting Description	Our definition of adverse event does not differ from the clinicaltrials.gov definition.
Arm/Group Title	Control Group		Experimental Group
Arm/Group Description	This group receives no experimental bracing intervention in the study.		Breg Fusion Osteoarthritis knee unloading brace Fusion OA Knee Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
All Cause Mortality
	Control Group		Experimental Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/22 (0%)
Serious Adverse Events
	Control Group		Experimental Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		2/22 (9.1%)
Cardiac disorders
SOB/A-Fib	0/19 (0%)		1/22 (4.5%)
Nervous system disorders
Shingles	0/19 (0%)		1/22 (4.5%)
Other (Not Including Serious) Adverse Events
	Control Group		Experimental Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/19 (15.8%)		3/22 (13.6%)
Injury, poisoning and procedural complications
Fall	0/19 (0%)	0	1/22 (4.5%)	1
Skin and subcutaneous tissue disorders
Rash	3/19 (15.8%)	3	2/22 (9.1%)	2

Limitations/Caveats

There was difficulty recruiting subjects for this study which lead to a small number of subjects analyzed. The results of this study should be interpreted with caution.

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.