Osteoarthritis of the KneeNCT02150057

Efficacy Study of an Unloading Brace for Knee Osteoarthritis

A study testing Breg Fusion Unloading Brace in people with Osteoarthritis of the Knee, run by Andrews Research & Education Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Osteoarthritis of the Knee
What is being tested?: Breg Fusion Unloading Brace
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Feb 2010to May 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Andrews Institute for Orthopaedics & Sports Medicine
Gulf Breeze, Florida, 32561

Other trials in United States

About this study

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

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.

Read the 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:

Fusion Osteoarthritis Knee Brace
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

Conditions: Osteoarthritis of the Knee
Being tested: Breg Fusion Unloading Brace
Keywords: knee osteoarthritis unicompartmental unloading brace
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Breg Fusion Unloading BraceDevice
Also called Breg Fusion Osteoarthritis Knee 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.

Study groups in NCT02150057
Study group	Role	What they receive
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. Receives: Device: Breg Fusion Unloading Brace

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010May 2013

First posted29 May 2014 (estimated)
Study startFeb 2010
Primary completionJun 2012
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Care provider
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02150057
Sponsor's protocol ID: BREG72609
Status last verified: Oct 2019
First submitted: 27 May 2014
Last updated: 22 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Cunningham LS, Kelsey JL. Epidemiology of musculoskeletal impairments and associated disability. Am J Public Health. 1984 Jun;74(6):574-9. doi: 10.2105/ajph.74.6.574.
PubMed 6232862
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. doi: 10.1002/1529-0131(199805)41:53.0.CO;2-V.
PubMed 9588729
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. doi: 10.1007/BF03324264.
PubMed 7893781
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.
PubMed 9101508
Gabriel SE, Crowson CS, O'Fallon WM. Costs of osteoarthritis: estimates from a geographically defined population. J Rheumatol Suppl. 1995 Feb;43:23-5.
PubMed 7752127
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. doi: 10.7326/0003-4819-131-6-199909210-00003.
PubMed 10498556
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. doi: 10.1097/00003086-200104000-00008.
PubMed 11302324
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.
PubMed 9606092
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.
PubMed 12016084
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.
PubMed 9228878
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.
PubMed 10225800
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.
PubMed 10486029
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.
PubMed 15558372
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.
PubMed 11041589
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.
PubMed 20086350

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Medial Compartment Unloading Brace Use for Osteoarthritis of the the Knee: A Prospective Randomized Study
ClinicalTrials.gov ID: NCT02150057
Acronym / sponsor ID: BREG72609
Conditions: Osteoarthritis of the Knee
Keywords: knee osteoarthritis unicompartmental unloading brace
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Andrews Research & Education FoundationUniversity, hospital or other
Collaborators: BREG, Inc
Study start: Feb 2010
Primary completion: Jun 2012 (actual)
Study completion: May 2013 (actual)
First posted: 29 May 2014 (estimated)
Results: Posted 22 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Fusion Osteoarthritis Knee Brace
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

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Control Group	No intervention	–This group receives no experimental bracing intervention in the study.
Experimental Group	Active comparator	Device: Breg Fusion Unloading BraceThis 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.

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Breg Fusion Unloading BraceAlso: Breg Fusion Osteoarthritis Knee Unloading BraceThis group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.	Device	Experimental Group

Primary outcome

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
Time frame: 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.

Results and safety

Results posted to the registry on 22 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	25	19
Experimental Group	26	22

Primary outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score

Time frame: Baseline, 6 month follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Control Group n = 19	Experimental Group n = 22
Baseline Visit	2.92 (0.57)	2.86 (0.52)
6 Month Visit	3.03 (0.65)	2.67 (0.76)

Control Group vs Experimental Group: p <0.05, ANOVA

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

Adverse events

Time frame: Patients were monitored for adverse events for the 6 month duration that they were enrolled in the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 19 (0%)	3 of 19 (15.8%)	0 of 19
Experimental Group	2 of 22 (9.1%)	3 of 22 (13.6%)	0 of 22

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 6232862Cunningham LS, Kelsey JL. Epidemiology of musculoskeletal impairments and associated disability. Am J Public Health. 1984 Jun;74(6):574-9. doi: 10.2105/ajph.74.6.574.
Background: PubMed 9588729Lawrence 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. doi: 10.1002/1529-0131(199805)41:53.0.CO;2-V.
Background: PubMed 7893781Lethbridge-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. doi: 10.1007/BF03324264.
Background: PubMed 9101508Gabriel SE, Crowson CS, Campion ME, O'Fallon WM. Direct medical costs unique to people with arthritis. J Rheumatol. 1997 Apr;24(4):719-25.
Background: PubMed 7752127Gabriel SE, Crowson CS, O'Fallon WM. Costs of osteoarthritis: estimates from a geographically defined population. J Rheumatol Suppl. 1995 Feb;43:23-5.
Background: PubMed 10498556Rao 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. doi: 10.7326/0003-4819-131-6-199909210-00003.
Background: PubMed 11302324Buckwalter 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. doi: 10.1097/00003086-200104000-00008.
Background: PubMed 9606092Pollo FE. Bracing and heel wedging for unicompartmental osteoarthritis of the knee. Am J Knee Surg. 1998 Winter;11(1):47-50. No abstract available.
Background: PubMed 12016084Pollo 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.
Background: PubMed 9228878Matsuno 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.
Background: PubMed 10225800Kirkley 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.
Background: PubMed 10486029Katsuragawa 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.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis of the Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roger Ostrander, MD principal investigator

Andrews Institute for Orthopaedics & Sports Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Breg Fusion Unloading Brace in people with Osteoarthritis of the Knee, run by Andrews Research & Education Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score (time frame: Baseline, 6 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02150057, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.