Efficacy Study of an Unloading Brace for Knee Osteoarthritis

Osteoarthritis of the Knee Clinical Trial

Official title:

Efficacy of Medial Compartment Unloading Brace Use for Osteoarthritis of the the Knee: A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150057
• Other study ID #: BREG72609
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: May 2013

Study information

• Verified date: October 2019
• Source: Andrews Research & Education Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Andrews Institute for Orthopaedics & Sports Medicine	Gulf Breeze	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Andrews Research & Education Foundation	BREG, Inc

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

Cunningham LS, Kelsey JL. Epidemiology of musculoskeletal impairments and associated disability. Am J Public Health. 1984 Jun;74(6):574-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Gabriel SE, Crowson CS, O'Fallon WM. Costs of osteoarthritis: estimates from a geographically defined population. J Rheumatol Suppl. 1995 Feb;43:23-5. — View Citation

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. — View Citation

Katsuragawa Y, Fukui N, Nakamura K. Change of bone mineral density with valgus knee bracing. Int Orthop. 1999;23(3):164-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pollo FE. Bracing and heel wedging for unicompartmental osteoarthritis of the knee. Am J Knee Surg. 1998 Winter;11(1):47-50. Review. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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