Back to resultsEfficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis (UNIBRACE)
Primary Purpose
Osteoarthritis, Knee
Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
UniRelieverTM offloading brace (THUASNE)
Unloader One® X brace (Össur)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee Brace, Knee functional capacity, Pain, Compliance
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Medial femorotibial knee osteoarthritis grade 2, 3 or 4 according to the Kellgren Lawrence system Visual Analog Scale pain ≥ 40/100 in the last 48 hours Signed informed consent prior to any study-mandated procedure. Affiliated to the General regime of the Social Security or covered by a similar health insurance system Exclusion Criteria: Inability to walk or dependance on a wheelchair or use of crutches. Diseases that do not allow participation in the study for a period of six weeks. Concomitant ipsilateral patellofemoral osteoarthritis associated with a more severe pain than the one for medial OA. Ipsilateral osteoarthritis of the hip associated with a more severe pain than the one for medial OA. A body mass index over 35. Successful Cortisone injection within the last four weeks before the start of the study. Participation to any other clinical study which has an impact on the different endpoints. Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent. Inability to communicate in German.
Sites / Locations
- Trauma Orthopedic Surgery Practice Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Group I
Group II
Group III
Arm Description
Patients wearing the UniRelieverTM offloading brace (THUASNE): For intervention group I, in addition to the usual care described above for the control group, patients will wear the studied UniRelieverTM offloading brace.
Patients wearing the Unloader One® X brace (Össur): For intervention group II, in addition to the usual care described above for the control group, patients will wear the Unloader One® X brace by Össur
Patients wearing no orthosis: In the control group, usual care is defined by: buffer heel and/or insoles and/or outer edge raisin and/or walking stick and/or physiotherapy and/ or analgesics oral and local depending on the patient's needs.
Outcomes
Primary Outcome Measures
Pain-free walking distance
The evolution of pain-free walking distance evaluated by reporting the distance that the patient can walk without pain.
Secondary Outcome Measures
Knee functional capacity
The evolution of knee functional capacity is evaluated by the Lequesne index completed by the patient at inclusion and six weeks of follow-up (minimum index score 0: None handicap, maximum index score 24: Handicap extremely severe)
Pain on loading
The evolution of pain on loading is measured via a numerical rating scale (NRS) after a thirty-minute walk at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
Pain at rest
The evolution of pain at rest is measured via a numerical rating scale (NRS) at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
Analgesic consumption
The use of analgesics is collected all along the study via a patient's diary completed by the patient every day and via the physician during the inclusion and the six weeks follow-up visit .
Subjective range of movement
The subjective knee range of movement is assessed qualitatively by having patients rate it as follow:
'clearly improved',
'improved',
'unchanged',
'deteriorated'
'clearly deteriorated'.
Objective range of movement
The objective improvement of knee range of movement is assessed quantitatively by a goniometer (range of movement measure expressed in degrees)
Assessment of Patient's Global Impression of Change (PGI-C)
Patient's opinion on Global Impression of Change about his/her general condition by using the PGIC questionnaire completed at the six weeks follow-up visit by the patient. The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference (better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference
Assessment of compliance
The evaluation of compliance with devices during the duration of the study is reported by the investigator according to the patient's diary completed by the patient each day.
Assessment of patient's satisfaction
The evaluation of patient satisfaction with devices is assessed via a self-questionnaire at the end of the study
Assessment of safety (AE and SAEs)
The safety of the devices is evaluated by the description of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the study and collected by the patient via the patient's diary and the investigator during follow-up visits:
number,
type,
frequency,
intensity,
relationship with the study device
Full Information
NCT ID
NCT05905809
First Posted
May 26, 2023
Last Updated
June 6, 2023
Sponsor
Thuasne
Collaborators
MED-RAS GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05905809
Brief Title
Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
Acronym
UNIBRACE
Official Title
Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thuasne
Collaborators
MED-RAS GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.
Detailed Description
Osteoarthritis (OA) is one of the leading causes of physical disability in the world, affecting a growing portion of the elderly, indeed, it is estimated that 85% of all people over age 60 have some degree of OA (Parween et al. 2019).
A survey of 2000 French general practitioners indicated that 10% usually prescribe knee orthoses for patients with knee OA. With the increasing importance of non-pharmacological treatment in recommendations for OA, orthoses will increase in use (Beaudreuil 2017).
The use of an offloading knee brace that encompasses the knee has proven to be a safe, cost-efficient treatment option for reducing pain and improving function. It can even delay the need for surgery.
The aim of this study is to perform a randomized, prospective, interventional, 3-arm parallel group study to look at the difference in outcome in knee osteoarthritic patient with the use of the new semi-rigid offloading brace versus knee brace comparator versus without orthosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee Brace, Knee functional capacity, Pain, Compliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An interventional, prospective, monocentric, randomized, open and controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
Patients wearing the UniRelieverTM offloading brace (THUASNE):
For intervention group I, in addition to the usual care described above for the control group, patients will wear the studied UniRelieverTM offloading brace.
Arm Title
Group II
Arm Type
Experimental
Arm Description
Patients wearing the Unloader One® X brace (Össur):
For intervention group II, in addition to the usual care described above for the control group, patients will wear the Unloader One® X brace by Össur
Arm Title
Group III
Arm Type
No Intervention
Arm Description
Patients wearing no orthosis:
In the control group, usual care is defined by:
buffer heel and/or
insoles and/or
outer edge raisin and/or
walking stick and/or
physiotherapy and/ or
analgesics oral and local depending on the patient's needs.
Intervention Type
Device
Intervention Name(s)
UniRelieverTM offloading brace (THUASNE)
Intervention Description
The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it
Intervention Type
Device
Intervention Name(s)
Unloader One® X brace (Össur)
Intervention Description
The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it
Primary Outcome Measure Information:
Title
Pain-free walking distance
Description
The evolution of pain-free walking distance evaluated by reporting the distance that the patient can walk without pain.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Knee functional capacity
Description
The evolution of knee functional capacity is evaluated by the Lequesne index completed by the patient at inclusion and six weeks of follow-up (minimum index score 0: None handicap, maximum index score 24: Handicap extremely severe)
Time Frame
6 weeks
Title
Pain on loading
Description
The evolution of pain on loading is measured via a numerical rating scale (NRS) after a thirty-minute walk at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
Time Frame
6 weeks
Title
Pain at rest
Description
The evolution of pain at rest is measured via a numerical rating scale (NRS) at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
Time Frame
6 weeks
Title
Analgesic consumption
Description
The use of analgesics is collected all along the study via a patient's diary completed by the patient every day and via the physician during the inclusion and the six weeks follow-up visit .
Time Frame
6 weeks
Title
Subjective range of movement
Description
The subjective knee range of movement is assessed qualitatively by having patients rate it as follow:
'clearly improved',
'improved',
'unchanged',
'deteriorated'
'clearly deteriorated'.
Time Frame
6 weeks
Title
Objective range of movement
Description
The objective improvement of knee range of movement is assessed quantitatively by a goniometer (range of movement measure expressed in degrees)
Time Frame
6 weeks
Title
Assessment of Patient's Global Impression of Change (PGI-C)
Description
Patient's opinion on Global Impression of Change about his/her general condition by using the PGIC questionnaire completed at the six weeks follow-up visit by the patient. The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference (better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference
Time Frame
6 weeks
Title
Assessment of compliance
Description
The evaluation of compliance with devices during the duration of the study is reported by the investigator according to the patient's diary completed by the patient each day.
Time Frame
6 weeks
Title
Assessment of patient's satisfaction
Description
The evaluation of patient satisfaction with devices is assessed via a self-questionnaire at the end of the study
Time Frame
6 weeks
Title
Assessment of safety (AE and SAEs)
Description
The safety of the devices is evaluated by the description of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the study and collected by the patient via the patient's diary and the investigator during follow-up visits:
number,
type,
frequency,
intensity,
relationship with the study device
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Medial femorotibial knee osteoarthritis grade 2, 3 or 4 according to the Kellgren Lawrence system
Visual Analog Scale pain ≥ 40/100 in the last 48 hours
Signed informed consent prior to any study-mandated procedure.
Affiliated to the General regime of the Social Security or covered by a similar health insurance system
Exclusion Criteria:
Inability to walk or dependance on a wheelchair or use of crutches.
Diseases that do not allow participation in the study for a period of six weeks.
Concomitant ipsilateral patellofemoral osteoarthritis associated with a more severe pain than the one for medial OA.
Ipsilateral osteoarthritis of the hip associated with a more severe pain than the one for medial OA.
A body mass index over 35.
Successful Cortisone injection within the last four weeks before the start of the study.
Participation to any other clinical study which has an impact on the different endpoints.
Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
Inability to communicate in German.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tjark Siedentop, Dr
Phone
(0)1511 4858610
Ext
+49
Email
tjark.siedentop@thuasne.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Benning, MD
Organizational Affiliation
Trauma Orthopedic Surgery Practice Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trauma Orthopedic Surgery Practice Center
City
Aachen
State/Province
Friedrich-Wilhelm-Platz 5
ZIP/Postal Code
52062
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Benning, MD
Phone
0241-95786276
Email
m.benning@exinmo.de
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27939833
Citation
Beaudreuil J. Orthoses for osteoarthritis: A narrative review. Ann Phys Rehabil Med. 2017 Apr;60(2):102-106. doi: 10.1016/j.rehab.2016.10.005. Epub 2016 Dec 6.
Results Reference
background
PubMed Identifier
29736571
Citation
Grazina R, Andrade R, Bastos R, Costa D, Pereira R, Marinhas J, Maestro A, Espregueira-Mendes J. Clinical Management in Early OA. Adv Exp Med Biol. 2018;1059:111-135. doi: 10.1007/978-3-319-76735-2_5.
Results Reference
background
PubMed Identifier
30243296
Citation
Hjartarson HF, Toksvig-Larsen S. The clinical effect of an unloader brace on patients with osteoarthritis of the knee, a randomized placebo controlled trial with one year follow up. BMC Musculoskelet Disord. 2018 Sep 22;19(1):341. doi: 10.1186/s12891-018-2256-7.
Results Reference
background
PubMed Identifier
25160784
Citation
Maleki M, Arazpour M, Joghtaei M, Hutchins SW, Aboutorabi A, Pouyan A. The effect of knee orthoses on gait parameters in medial knee compartment osteoarthritis: A literature review. Prosthet Orthot Int. 2016 Apr;40(2):193-201. doi: 10.1177/0309364614547411. Epub 2014 Aug 26.
Results Reference
background
PubMed Identifier
31168421
Citation
Parween R, Shriram D, Mohan RE, Lee YHD, Subburaj K. Methods for evaluating effects of unloader knee braces on joint health: a review. Biomed Eng Lett. 2019 Jan 23;9(2):153-168. doi: 10.1007/s13534-019-00094-z. eCollection 2019 May.
Results Reference
background
PubMed Identifier
30255369
Citation
Petersen W, Ellermann A, Henning J, Nehrer S, Rembitzki IV, Fritz J, Becher C, Albasini A, Zinser W, Laute V, Ruhnau K, Stinus H, Liebau C. Non-operative treatment of unicompartmental osteoarthritis of the knee: a prospective randomized trial with two different braces-ankle-foot orthosis versus knee unloader brace. Arch Orthop Trauma Surg. 2019 Feb;139(2):155-166. doi: 10.1007/s00402-018-3040-8. Epub 2018 Sep 25.
Results Reference
background
PubMed Identifier
15094138
Citation
Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004 May;12(5):389-99. doi: 10.1016/j.joca.2004.02.001.
Results Reference
background
PubMed Identifier
21273902
Citation
Raja K, Dewan N. Efficacy of knee braces and foot orthoses in conservative management of knee osteoarthritis: a systematic review. Am J Phys Med Rehabil. 2011 Mar;90(3):247-62. doi: 10.1097/PHM.0b013e318206386b.
Results Reference
background
Links:
URL
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-used-treatment-osteoarthritis_en.pdf
Description
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
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Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
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