Reduced Knee FlexionNCT00857701
Dynamic Splinting After Total Knee Arthroplasty
A study testing Knee Extension Dynasplint in people with Reduced Knee Flexion, run by Dynasplint Systems, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Reduced Knee Flexion
- What is being tested?
- Knee Extension Dynasplint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reduced flexibility in AROM of knee extension
- Pain that is worsened by bending over while legs are straight
- Impaired gait pattern
- Ability to understand informed consent and experiment responsibilities
Who cannot join
- Fractures
- Knee sepsis
- Osteomyelitis or any orthopedic infection
- Extensor mechanism dysfunction
- Psoriasis
- Knee joint neuropathy
- Previous Stroke or Brain Injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Splinting After Total Knee Arthroplasty: a Randomized, Controlled Trial
The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty.
Read the detailed description
The purpose of the study is to evaluate the efficacy of dynamic splinting for knee flexion contracture following a total knee arthroplasty.
- Conditions
- Reduced Knee Flexion
- Being tested
- Knee Extension Dynasplint
- Keywords
- total knee arthroplasty, Dynamic Splinting, Knee extension, knee, Reduced knee flexion after total knee arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee Extension DynasplintDevice
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Patient will receive post-surgical standard of care treatment with standard Physical therapy and NSAIDs. |
| 2 | Experimental | Patients will be treated with the Standard of Care physical therapy and NSAIDs as well as a Knee Extension Dynasplint that includes tension chambers. Receives: Device: Knee Extension Dynasplint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Acitive Range of Mothion in knee extension
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2015 (estimated)
Why it stopped: Unrelated to trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Reduced Knee FlexionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynasplint Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857701
- Sponsor's protocol ID
- 2008.009
- Status last verified
- Aug 2013
- First submitted
- 6 Mar 2009
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Denis M, Moffet H, Caron F, Ouellet D, Paquet J, Nolet L. Effectiveness of continuous passive motion and conventional physical therapy after total knee arthroplasty: a randomized clinical trial. Phys Ther. 2006 Feb;86(2):174-85.
PubMed 16445331Scuderi GR, Kochhar T. Management of flexion contracture in total knee arthroplasty. J Arthroplasty. 2007 Jun;22(4 Suppl 1):20-4. doi: 10.1016/j.arth.2006.12.110.
PubMed 17570272Kotani A, Yonekura A, Bourne RB. Factors influencing range of motion after contemporary total knee arthroplasty. J Arthroplasty. 2005 Oct;20(7):850-6. doi: 10.1016/j.arth.2004.12.051.
PubMed 16230234Jansen CM, Windau JE, Bonutti PM, Brillhart MV. Treatment of a knee contracture using a knee orthosis incorporating stress-relaxation techniques. Phys Ther. 1996 Feb;76(2):182-6. doi: 10.1093/ptj/76.2.182.
PubMed 8592722Fitzgerald GK, Childs JD, Ridge TM, Irrgang JJ. Agility and perturbation training for a physically active individual with knee osteoarthritis. Phys Ther. 2002 Apr;82(4):372-82.
PubMed 11922853Laskin RS, Beksac B. Stiffness after total knee arthroplasty. J Arthroplasty. 2004 Jun;19(4 Suppl 1):41-6. doi: 10.1016/j.arth.2004.02.008.
PubMed 15190548Bourne RB, Laskin RS, Guerin JS. Ten-year results of the first 100 Genesis II total knee replacement procedures. Orthopedics. 2007 Aug;30(8 Suppl):83-5.
PubMed 17824343Bradbury N, Borton D, Spoo G, Cross MJ. Participation in sports after total knee replacement. Am J Sports Med. 1998 Jul-Aug;26(4):530-5. doi: 10.1177/03635465980260041001.
PubMed 9689373Cloutier JM, Sabouret P, Deghrar A. Total knee arthroplasty with retention of both cruciate ligaments. A nine to eleven-year follow-up study. J Bone Joint Surg Am. 1999 May;81(5):697-702. doi: 10.2106/00004623-199905000-00011.
PubMed 10360698Kawamura H, Bourne RB. Factors affecting range of flexion after total knee arthroplasty. J Orthop Sci. 2001;6(3):248-52. doi: 10.1007/s007760100043.
PubMed 11484119Kahle JT, Highsmith MJ, Hubbard SL. Comparison of nonmicroprocessor knee mechanism versus C-Leg on Prosthesis Evaluation Questionnaire, stumbles, falls, walking tests, stair descent, and knee preference. J Rehabil Res Dev. 2008;45(1):1-14. doi: 10.1682/jrrd.2007.04.0054.
PubMed 18566922
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Splinting After Total Knee Arthroplasty: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00857701
- Acronym / sponsor ID
- 2008.009
- Conditions
- Reduced Knee Flexion
- Keywords
- total knee arthroplasty, Dynamic Splinting, Knee extension, knee, Reduced knee flexion after total knee arthroscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unrelated to trial
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dynasplint Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- May 2015 (estimated)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty.
Detailed description
The purpose of the study is to evaluate the efficacy of dynamic splinting for knee flexion contracture following a total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Patient will receive post-surgical standard of care treatment with standard Physical therapy and NSAIDs. |
| 2 | Experimental | Device: Knee Extension DynasplintPatients will be treated with the Standard of Care physical therapy and NSAIDs as well as a Knee Extension Dynasplint that includes tension chambers. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Reduced flexibility in AROM of knee extension
- Pain that is worsened by bending over while legs are straight
- Impaired gait pattern
- Ability to understand informed consent and experiment responsibilities
Key exclusion criteria (7 listed)
- Fractures
- Knee sepsis
- Osteomyelitis or any orthopedic infection
- Extensor mechanism dysfunction
- Psoriasis
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 |
|---|---|---|
| Knee Extension DynasplintDynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device. | Device | 2 |
Primary outcome
Change in Maximal Acitive Range of Mothion in knee extension
Time frame: 9 weeks
Results and safety
The study was stopped early (reason given: Unrelated to trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Background: PubMed 16445331Denis M, Moffet H, Caron F, Ouellet D, Paquet J, Nolet L. Effectiveness of continuous passive motion and conventional physical therapy after total knee arthroplasty: a randomized clinical trial. Phys Ther. 2006 Feb;86(2):174-85.
- Background: PubMed 17570272Scuderi GR, Kochhar T. Management of flexion contracture in total knee arthroplasty. J Arthroplasty. 2007 Jun;22(4 Suppl 1):20-4. doi: 10.1016/j.arth.2006.12.110.
- Background: PubMed 16230234Kotani A, Yonekura A, Bourne RB. Factors influencing range of motion after contemporary total knee arthroplasty. J Arthroplasty. 2005 Oct;20(7):850-6. doi: 10.1016/j.arth.2004.12.051.
- Background: PubMed 8592722Jansen CM, Windau JE, Bonutti PM, Brillhart MV. Treatment of a knee contracture using a knee orthosis incorporating stress-relaxation techniques. Phys Ther. 1996 Feb;76(2):182-6. doi: 10.1093/ptj/76.2.182.
- Background: PubMed 11922853Fitzgerald GK, Childs JD, Ridge TM, Irrgang JJ. Agility and perturbation training for a physically active individual with knee osteoarthritis. Phys Ther. 2002 Apr;82(4):372-82.
- Background: PubMed 15190548Laskin RS, Beksac B. Stiffness after total knee arthroplasty. J Arthroplasty. 2004 Jun;19(4 Suppl 1):41-6. doi: 10.1016/j.arth.2004.02.008.
- Background: PubMed 17824343Bourne RB, Laskin RS, Guerin JS. Ten-year results of the first 100 Genesis II total knee replacement procedures. Orthopedics. 2007 Aug;30(8 Suppl):83-5.
- Background: PubMed 9689373Bradbury N, Borton D, Spoo G, Cross MJ. Participation in sports after total knee replacement. Am J Sports Med. 1998 Jul-Aug;26(4):530-5. doi: 10.1177/03635465980260041001.
- Background: PubMed 10360698Cloutier JM, Sabouret P, Deghrar A. Total knee arthroplasty with retention of both cruciate ligaments. A nine to eleven-year follow-up study. J Bone Joint Surg Am. 1999 May;81(5):697-702. doi: 10.2106/00004623-199905000-00011.
- Background: PubMed 11484119Kawamura H, Bourne RB. Factors affecting range of flexion after total knee arthroplasty. J Orthop Sci. 2001;6(3):248-52. doi: 10.1007/s007760100043.
- Background: PubMed 18566922Kahle JT, Highsmith MJ, Hubbard SL. Comparison of nonmicroprocessor knee mechanism versus C-Leg on Prosthesis Evaluation Questionnaire, stumbles, falls, walking tests, stair descent, and knee preference. J Rehabil Res Dev. 2008;45(1):1-14. doi: 10.1682/jrrd.2007.04.0054.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Extension Dynasplint in people with Reduced Knee Flexion, run by Dynasplint Systems, Inc. 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Aug 2013. 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?
The study was stopped early (reason given: Unrelated to trial). Results are not available in the source record.
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?
Change in Maximal Acitive Range of Mothion in knee extension (time frame: 9 weeks). 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 NCT00857701, which also lists 11 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 12 Aug 2013.