Efficacy Study of an Unloading Brace for Knee Osteoarthritis

NCT02150057 | Completed Results DMC

• 1 other identifier: BREG72609
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of the Knee

Keywords

knee osteoarthritis unicompartmental unloading brace

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score

  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.

  Baseline, 6 month follow-up

Study Arms (2)

Control Group

NO INTERVENTION

This group receives no experimental bracing intervention in the study.

Experimental Group

ACTIVE COMPARATOR

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

Interventions

Breg Fusion Unloading Brace DEVICE

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.

Also known as: Breg Fusion Osteoarthritis Knee Unloading Brace

Experimental Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead
• BREG, Inc: collaborator

Study Sites (1)

Andrews Institute for Orthopaedics & Sports Medicine

Gulf Breeze, Florida, 32561, United States

Location

Related Publications (17)

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  PMID: 9101508 BACKGROUND

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  PMID: 7752127 BACKGROUND

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  PMID: 10498556 BACKGROUND

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  PMID: 11302324 BACKGROUND

• Pollo FE. Bracing and heel wedging for unicompartmental osteoarthritis of the knee. Am J Knee Surg. 1998 Winter;11(1):47-50. No abstract available.

  PMID: 9606092 BACKGROUND

• 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. doi: 10.1177/03635465020300031801.

  PMID: 12016084 BACKGROUND

• 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. doi: 10.1016/s0003-9993(97)90083-6.

  PMID: 9228878 BACKGROUND

• 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. doi: 10.2106/00004623-199904000-00012.

  PMID: 10225800 BACKGROUND

• Katsuragawa Y, Fukui N, Nakamura K. Change of bone mineral density with valgus knee bracing. Int Orthop. 1999;23(3):164-7. doi: 10.1007/s002640050337.

  PMID: 10486029 BACKGROUND

• 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. doi: 10.1682/jrrd.2004.02.0187.

  PMID: 15558372 BACKGROUND

• 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. doi: 10.1302/0301-620x.82b7.10638.

  PMID: 11041589 BACKGROUND

• 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.

  PMID: 20086350 BACKGROUND

• 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. doi: 10.1093/rheumatology/40.3.285.

  PMID: 11285375 BACKGROUND

• 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.

  PMID: 12180625 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and 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.

Results Point of Contact

• Title: Dr. Roger Ostrander
• Organization: Andrews Institute for Orthopaedics & Sports Medicine

rostrander@flboneandjoint.com

850-916-3700

Study Officials

• Roger Ostrander, MD

  Andrews Institute for Orthopaedics & Sports Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation: 1. Breg Fusion Osteoarthritis Knee Brace 2. No brace group Both groups will be allowed to continue standard conservative treatment of osteoarthritis including anti-inflammatory medications, home exercises and joint supplements.

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 29, 2014
• Study Start: February 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: May 1, 2013
• Last Updated: October 22, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)