Arthroplasty, Replacement, KneeNCT04837872
Static Progressive Splinting in the Management of Knee Stiffness Following Total Knee Arthroplasty
A study testing Multimodal Physical Therapy (MPT) in people with Arthroplasty, Replacement, Knee, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Multimodal Physical Therapy (MPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2017to 12 Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergone a unilateral primary Total Knee Arthroplasty (TKA) for end-stage osteoarthritis
- Knee stiffness in the first 6 weeks post-operative defined as knee flexion < 100 degrees
Who cannot join
- Preoperative knee range of motion less than 15-110 degrees
- Intraoperative (closed) range of motion < 0-120 degrees
- Radiographic signs of heterotopic ossification
- Misaligned components or component-related failures of knee prosthesis that could be responsible for difficulties with motion
- Signs and symptoms consistent with joint infection
- Signs and symptoms consistent with complex regional pain syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Panorama Orthopedics & Spine Center
Golden, Colorado, 80401
About this study
The purpose of this study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following total knee arthroplasty (TKA). Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to manipulation under anesthesia (MUA) which is the current standard of care for knee stiffness after TKA.
Read the detailed description
Total knee arthroplasty (TKA) is the standard of care to manage the pain and disability associated with end-stage knee osteoarthritis, with more than 700,000 TKA surgeries performed annually in the United States. Knee stiffness, commonly caused by arthrofibrosis, is an infrequent, but debilitating complication of TKA, with an incidence upwards of 5% postoperatively. As a predominant failure mechanism, knee stiffness accounts for 28% of hospital readmissions due to surgical complications within 90 days of discharge, and 10% of all revisions within 5 years of initial surgery within the United States. With the incidence of TKA projected to reach 3.5 million by 2030, the growing cohort of TKA patients with postoperative knee stiffness provides an important target for research.
Several treatments for knee stiffness have been described including static progressive splinting and manipulation under anesthesia (MUA). To date, no studies have compared the use of static progressive splinting in the early management of individuals presenting with knee stiffness after TKA to more commonly utilized surgical procedures such as MUA. Witvrouw and colleagues compared a computer-controlled passive motion device to MUA for individuals with knee stiffness after TKA and found that stretching device had similar outcomes to MUA in terms of range of motion (ROM) and self-reported pain, stiffness and function. A key limitation of this study is that the computer-controlled motion device is not commercially available and therefore translation of this technology into practice is unlikely. However, this study does demonstrate that conservative stretching techniques may be as efficacious as costlier surgical techniques as well as may cause fewer adverse events such as quadriceps tendon rupture and fractures. Only one study to date has examined the utilization of static progressive splinting after TKA. In this study, they enrolled patients who had already failed MUA and conservative physical therapy management strategies. They found that the average ROM increase for patients was 25° as well as 92% of patients were satisfied with the results and no complications occurred with use of the device. Key limitations to this study are the lack of a comparison group as well as static progressive splinting was utilized after MUA had already failed. It is unknown how individuals would respond to this treatment compared to MUA.
Therefore, the purpose of our study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following TKA within the current surgical practice of Dr. Jared Foran at Panorama Orthopedics \& Spine Center. Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to MUA which is the current standard of care for knee stiffness after TKA.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Multimodal Physical Therapy (MPT)
- Keywords
- static progressive splinting, manual therapy, physical therapy, rehabilitation, arthrofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Physical Therapy (MPT)Other
Individualized physical therapy and static progressive splint (flexion with or without extension splint).
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Physical Therapy (MPT) | Experimental | The multimodal physical therapy (MPT) program consisted of manual therapy, therapeutic exercise, and utilization of a static progressive splint (Joint Active Systems SPS Knee, Effingham, IL). Although the primary focus of this study was on improving knee flexion ROM, two protocols were developed: one to improve flexion deficits and one to improve extension deficits. Participants in the MPT group received physical therapy 2x per week for 4 weeks. They were instructed to use the static progressive splint(s) 3x per day for 30 minute sessions (90 minutes total per day) for each splint (e.g., 90 minutes for flexion splint, 90 minutes for extension splint). Receives: Other: Multimodal Physical Therapy (MPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Passive knee flexion and extension measured with goniometry
Measured: 4 weeks
Secondary outcomes (3)
Adherence to Splint Use
Adherence to splint use was tracked with a log completed by participants; they were instructed to place a checkmark for each day they used the JAS splint per protocol (30-minute sessions, 3 times daily). Adherence was calculated as days of splint use completed divided by days of splint use prescribed; a priori adherence levels were considered acceptable if the mean was ≥ 80 percent.
Measured: 4 weeks
Satisfaction with Splint
Satisfaction was assessed with a 7-point Likert scale ranging from 1 "extremely dissatisfied" to 7 "extremely satisfied". Participants responded based on the following instruction: please rate your satisfaction with your knee splint on the scale. A priori satisfaction was considered acceptable if the median score was ≥ 4 ("somewhat satisfied" or higher).
Measured: 4 weeks
Safety of splint use: adverse events
Count and description of adverse events related to splint use
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start25 May 2017
- Primary completion27 Feb 2018
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Panorama Orthopedics & Spine Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837872
- Sponsor's protocol ID
- 17-0241
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yercan HS, Sugun TS, Bussiere C, Ait Si Selmi T, Davies A, Neyret P. Stiffness after total knee arthroplasty: prevalence, management and outcomes. Knee. 2006 Mar;13(2):111-7. doi: 10.1016/j.knee.2005.10.001. Epub 2006 Feb 20.
PubMed 16490357Schroer WC, Berend KR, Lombardi AV, Barnes CL, Bolognesi MP, Berend ME, Ritter MA, Nunley RM. Why are total knees failing today? Etiology of total knee revision in 2010 and 2011. J Arthroplasty. 2013 Sep;28(8 Suppl):116-9. doi: 10.1016/j.arth.2013.04.056. Epub 2013 Aug 15.
PubMed 23954423Schairer WW, Vail TP, Bozic KJ. What are the rates and causes of hospital readmission after total knee arthroplasty? Clin Orthop Relat Res. 2014 Jan;472(1):181-7. doi: 10.1007/s11999-013-3030-7.
PubMed 23645339Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Bonutti PM, Marulanda GA, McGrath MS, Mont MA, Zywiel MG. Static progressive stretch improves range of motion in arthrofibrosis following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2010 Feb;18(2):194-9. doi: 10.1007/s00167-009-0947-1. Epub 2009 Oct 14.
PubMed 19826784Manrique J, Gomez MM, Parvizi J. Stiffness after total knee arthroplasty. J Knee Surg. 2015 Apr;28(2):119-26. doi: 10.1055/s-0034-1396079. Epub 2014 Dec 16.
PubMed 25513992Witvrouw E, Bellemans J, Victor J. Manipulation under anaesthesia versus low stretch device in poor range of motion after TKA. Knee Surg Sports Traumatol Arthrosc. 2013 Dec;21(12):2751-8. doi: 10.1007/s00167-012-2152-x. Epub 2012 Aug 3.
PubMed 22864680Rauzi MR, Foran JRH, Bade MJ. Multimodal conservative management of arthrofibrosis after total knee arthroplasty compared to manipulation under anesthesia: a feasibility study with retrospective cohort comparison. Pilot Feasibility Stud. 2022 Mar 25;8(1):71. doi: 10.1186/s40814-022-01026-y.
PubMed 35337388
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Static Progressive Splinting in the Management of Knee Stiffness Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04837872
- Acronym / sponsor ID
- 17-0241
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- static progressive splinting, manual therapy, physical therapy, rehabilitation, arthrofibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Panorama Orthopedics & Spine Center
- Study start
- 25 May 2017 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 8 Apr 2021 (actual)
- 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 determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following total knee arthroplasty (TKA). Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to manipulation under anesthesia (MUA) which is the current standard of care for knee stiffness after TKA.
Detailed description
Total knee arthroplasty (TKA) is the standard of care to manage the pain and disability associated with end-stage knee osteoarthritis, with more than 700,000 TKA surgeries performed annually in the United States. Knee stiffness, commonly caused by arthrofibrosis, is an infrequent, but debilitating complication of TKA, with an incidence upwards of 5% postoperatively. As a predominant failure mechanism, knee stiffness accounts for 28% of hospital readmissions due to surgical complications within 90 days of discharge, and 10% of all revisions within 5 years of initial surgery within the United States. With the incidence of TKA projected to reach 3.5 million by 2030, the growing cohort of TKA patients with postoperative knee stiffness provides an important target for research.
Several treatments for knee stiffness have been described including static progressive splinting and manipulation under anesthesia (MUA). To date, no studies have compared the use of static progressive splinting in the early management of individuals presenting with knee stiffness after TKA to more commonly utilized surgical procedures such as MUA. Witvrouw and colleagues compared a computer-controlled passive motion device to MUA for individuals with knee stiffness after TKA and found that stretching device had similar outcomes to MUA in terms of range of motion (ROM) and self-reported pain, stiffness and function. A key limitation of this study is that the computer-controlled motion device is not commercially available and therefore translation of this technology into practice is unlikely. However, this study does demonstrate that conservative stretching techniques may be as efficacious as costlier surgical techniques as well as may cause fewer adverse events such as quadriceps tendon rupture and fractures. Only one study to date has examined the utilization of static progressive splinting after TKA. In this study, they enrolled patients who had already failed MUA and conservative physical therapy management strategies. They found that the average ROM increase for patients was 25° as well as 92% of patients were satisfied with the results and no complications occurred with use of the device. Key limitations to this study are the lack of a comparison group as well as static progressive splinting was utilized after MUA had already failed. It is unknown how individuals would respond to this treatment compared to MUA.
Therefore, the purpose of our study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following TKA within the current surgical practice of Dr. Jared Foran at Panorama Orthopedics \& Spine Center. Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to MUA which is the current standard of care for knee stiffness after TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Physical Therapy (MPT) | Experimental | Other: Multimodal Physical Therapy (MPT)The multimodal physical therapy (MPT) program consisted of manual therapy, therapeutic exercise, and utilization of a static progressive splint (Joint Active Systems SPS Knee, Effingham, IL). Although the primary focus of this study was on improving knee flexion ROM, two protocols were developed: one to improve flexion deficits and one to improve extension deficits. Participants in the MPT group received physical therapy 2x per week for 4 weeks. They were instructed to use the static progressive splint(s) 3x per day for 30 minute sessions (90 minutes total per day) for each splint (e.g., 90 minutes for flexion splint, 90 minutes for extension splint). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergone a unilateral primary Total Knee Arthroplasty (TKA) for end-stage osteoarthritis
- Knee stiffness in the first 6 weeks post-operative defined as knee flexion < 100 degrees
Key exclusion criteria (6 listed)
- Preoperative knee range of motion less than 15-110 degrees
- Intraoperative (closed) range of motion < 0-120 degrees
- Radiographic signs of heterotopic ossification
- Misaligned components or component-related failures of knee prosthesis that could be responsible for difficulties with motion
- Signs and symptoms consistent with joint infection
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 |
|---|---|---|
| Multimodal Physical Therapy (MPT)Individualized physical therapy and static progressive splint (flexion with or without extension splint). | Other | Multimodal Physical Therapy (MPT) |
Primary outcome
Range of Motion
Time frame: 4 weeks
Passive knee flexion and extension measured with goniometry
3 secondary outcomes
Adherence to Splint Use
Time frame: 4 weeks
Satisfaction with Splint
Time frame: 4 weeks
Safety of splint use: adverse events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Background: PubMed 16490357Yercan HS, Sugun TS, Bussiere C, Ait Si Selmi T, Davies A, Neyret P. Stiffness after total knee arthroplasty: prevalence, management and outcomes. Knee. 2006 Mar;13(2):111-7. doi: 10.1016/j.knee.2005.10.001. Epub 2006 Feb 20.
- Background: PubMed 23954423Schroer WC, Berend KR, Lombardi AV, Barnes CL, Bolognesi MP, Berend ME, Ritter MA, Nunley RM. Why are total knees failing today? Etiology of total knee revision in 2010 and 2011. J Arthroplasty. 2013 Sep;28(8 Suppl):116-9. doi: 10.1016/j.arth.2013.04.056. Epub 2013 Aug 15.
- Background: PubMed 23645339Schairer WW, Vail TP, Bozic KJ. What are the rates and causes of hospital readmission after total knee arthroplasty? Clin Orthop Relat Res. 2014 Jan;472(1):181-7. doi: 10.1007/s11999-013-3030-7.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Background: PubMed 19826784Bonutti PM, Marulanda GA, McGrath MS, Mont MA, Zywiel MG. Static progressive stretch improves range of motion in arthrofibrosis following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2010 Feb;18(2):194-9. doi: 10.1007/s00167-009-0947-1. Epub 2009 Oct 14.
- Background: PubMed 25513992Manrique J, Gomez MM, Parvizi J. Stiffness after total knee arthroplasty. J Knee Surg. 2015 Apr;28(2):119-26. doi: 10.1055/s-0034-1396079. Epub 2014 Dec 16.
- Background: PubMed 22864680Witvrouw E, Bellemans J, Victor J. Manipulation under anaesthesia versus low stretch device in poor range of motion after TKA. Knee Surg Sports Traumatol Arthrosc. 2013 Dec;21(12):2751-8. doi: 10.1007/s00167-012-2152-x. Epub 2012 Aug 3.
- Derived from this study: PubMed 35337388Rauzi MR, Foran JRH, Bade MJ. Multimodal conservative management of arthrofibrosis after total knee arthroplasty compared to manipulation under anesthesia: a feasibility study with retrospective cohort comparison. Pilot Feasibility Stud. 2022 Mar 25;8(1):71. doi: 10.1186/s40814-022-01026-y.
- Most Frequent Operating Room Procedures Performed in U.S. Hospitals, 2003-2012Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
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 Multimodal Physical Therapy (MPT) in people with Arthroplasty, Replacement, Knee, run by University of Colorado, Denver 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 2 inclusion and 6 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 13 Apr 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Range of Motion (time frame: 4 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 NCT04837872, which also lists 8 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 13 Apr 2021.