Aseptic Revision Knee ArthroplastyNCT07552415
Does Joint Immobilization Following Revision Total Knee Arthroplasty Improve Range of Motion Following Surgery?
A study testing Knee immobilizer and No Knee Immobilizer in people with Aseptic Revision Knee Arthroplasty and Stiffness Following Revision Knee Arthroplasty, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The goal of this study is to evaluate if knee immobilization for 10 days following revision total knee arthroplasty (rTKA) improves knee joint range of motion at 3 months postoperatively compared to standard of care postoperative protocol. Participants will be assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aseptic Revision Knee Arthroplasty, Stiffness Following Revision Knee Arthroplasty
- What is being tested?
- Knee immobilizer and No Knee Immobilizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients undergoing revision TKA for aseptic indications including aseptic loosening, polyethylene wear, instability, malalignment, periprosthetic fracture.
- Patients undergoing revision TKA of one or both components.
Who cannot join
- Patients who are undergoing revision TKA for stiffness.
- Patients with occult infection not recognized prior to revision.
- Patients with hinged TKA component reconstructions.
- Patients undergoing revision for liner exchange.
- History of VTE/PE.
- Patients on pre-operative anticoagulation.
- BMI ≥ 40.
- Patients with preoperative opioid use equal to or exceeding 150 Morphine Milligram Equivalents (MMEs)/day within 90 days of revision TKA.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Dr. Brian P. Chalmers MD, 212-606-1999, chalmersb@hss.edu
Allina Nocon, PhD, 646-714-6015, nocona@hss.edu
About this study
Official title: Does Joint Immobilization Following Revision Total Knee Arthroplasty (rTKA) Improve Range of Motion Following Surgery?
The goal of this study is to evaluate if knee immobilization for 10 days following revision total knee arthroplasty (rTKA) improves knee joint range of motion at 3 months postoperatively compared to standard of care postoperative protocol.
Participants will be assigned to one of two groups.
One group will wear a knee brace that keeps the knee straight for 10 days after surgery and will not perform knee range of motion exercises during that time. The other group will not wear a brace and will follow the standard physical therapy program, including knee range of motion exercises, starting after surgery.
Read the detailed description
Knee immobilization after revision total knee arthroplasty (TKA) remains unexplored in the literature despite its potential to address key challenges in the post-operative management and rehabilitation in these patients. Revision TKA is typically associated with higher rates of complications such as instability, malalignment, extensor mechanism disruption, and stiffness. Given the intricate nature of revision procedures and the increased risk of suboptimal outcomes, effective strategies for optimizing functional recovery and minimizing post-operative pain are critical. Semirigid extension bracing, a form of knee immobilization, has shown promise in primary TKA in improving pain management, promoting knee range of motion (ROM), and reducing opioid consumption. However, its role in revision TKA remains unknown. Exploring the use of knee immobilization in the revision TKA population could provide a non-pharmacological, cost-effective approach to addressing pain, minimizing complications, and improving long-term functional outcomes.
- Being tested
- Knee immobilizer, No Knee Immobilizer
- Keywords
- revision arthroplasty, stiffness, knee swelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee immobilizerDevice
Participants will wear a knee immobilizer brace for 10 days postoperatively and exclude knee range of motion exercises from postoperative physical therapy protocol during this period. They will resume all standard postoperative protocol after this period.
No Knee ImmobilizerDevice
Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants will wear a knee immobilizer brace for 10 days postoperatively and exclude knee range of motion exercises from postoperative physical therapy protocol during this period. They will resume all standard postoperative protocol after this period. Receives: Device: Knee immobilizer |
| Control Group | Placebo comparator | Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol. Receives: Device: No Knee Immobilizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion (degrees) - knee joint; measured using digital goniometer
Active and Passive knee flexion and extension range of motion will be measured in degrees using a standardized digital goniometer at each timepoint.
Measured: 3 months postoperatively
Secondary outcomes (11)
Range of motion (degrees) - knee joint; measured using a digital goniometer
Active and passive knee flexion and extension will be measured in degrees using a standardized digital goniometer. Measurements will be obtained with the patient seated for flexion and supine for extension at each timepoint.
Measured: 2 weeks, 6 weeks, and 1 year postoperatively
Swelling (mid-patellar circumference in centimeters) - knee joint; measured using a flexible measuring tape
Knee swelling will be measured as mid-patellar circumference (cm) with knee in full extension using a standardized flexible measuring tape at each postoperative timepoint.
Measured: 2 weeks, 6 weeks, 3 months and 1 year postoperatively
Stiffness - Knee Joint
Incidence of knee stiffness
Measured: 2 weeks, 6 weeks, 3 months, and 1 year postoperatively
Wound complications
Incidence of wound complications
Measured: 2 weeks, 6 weeks, 3 months, and 1 year postoperatively
Time to achieve physical therapy milestones
Measured: 2 weeks, 6 weeks, 3 months, and 1 year
Knee Society Scale Score Delta
Delta compared to preoperative value
Measured: 2 weeks, 6 weeks, 3 months, and 1 year
Functional Knee Society Scale Score Delta
Delta compared to preoperative value
Measured: 2 weeks, 6 weeks, 3 months, and 1 year
KOOS Jr. Score Delta
Delta compared to preoperative value
Measured: 2 weeks, 6 weeks, 3 months, and 1 year
PROMIS-10 Score Delta
Delta compared to preoperative value
Measured: 2 weeks, 6 weeks, 3 months, and 1 year
VAS Pain Score Delta
Delta compared to preoperative value
Measured: 2 weeks, 6 weeks, 3 months, and 1 year
Total 90 day opioid consumption
Measured: 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study startAug 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aseptic Revision Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Research and Education Foundation (OREF)
- Responsible party
- Principal investigator, Brian Chalmers, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552415
- Sponsor's protocol ID
- 2024-2192
- Status last verified
- Aug 2026
- First submitted
- 24 Mar 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tarazi JM, Chen Z, Scuderi GR, Mont MA. The Epidemiology of Revision Total Knee Arthroplasty. J Knee Surg. 2021 Nov;34(13):1396-1401. doi: 10.1055/s-0041-1735282. Epub 2021 Sep 10.
PubMed 34507367Postler A, Lutzner C, Beyer F, Tille E, Lutzner J. Analysis of Total Knee Arthroplasty revision causes. BMC Musculoskelet Disord. 2018 Feb 14;19(1):55. doi: 10.1186/s12891-018-1977-y.
PubMed 29444666Healy WL, Della Valle CJ, Iorio R, Berend KR, Cushner FD, Dalury DF, Lonner JH. Complications of total knee arthroplasty: standardized list and definitions of the Knee Society. Clin Orthop Relat Res. 2013 Jan;471(1):215-20. doi: 10.1007/s11999-012-2489-y.
PubMed 22810157Kaseb MH, Moharrami A, Mirghaderi SP, Fallah E, Razzaghof M, Moazen Jamshidi MM, Poopak A, Mortazavi SMJ. Effect of joint immobilization using extension splint immediately after total knee arthroplasty on post-operative knee function and pain: a randomized clinical trial. Int Orthop. 2022 Aug;46(8):1749-1759. doi: 10.1007/s00264-022-05428-8. Epub 2022 May 19.
PubMed 35587284
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Joint Immobilization Following Revision Total Knee Arthroplasty (rTKA) Improve Range of Motion Following Surgery?
- ClinicalTrials.gov ID
- NCT07552415
- Acronym / sponsor ID
- 2024-2192
- Keywords
- revision arthroplasty, stiffness, knee swelling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Orthopaedic Research and Education Foundation (OREF)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 27 Apr 2026 (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 goal of this study is to evaluate if knee immobilization for 10 days following revision total knee arthroplasty (rTKA) improves knee joint range of motion at 3 months postoperatively compared to standard of care postoperative protocol.
Participants will be assigned to one of two groups.
One group will wear a knee brace that keeps the knee straight for 10 days after surgery and will not perform knee range of motion exercises during that time. The other group will not wear a brace and will follow the standard physical therapy program, including knee range of motion exercises, starting after surgery.
Detailed description
Knee immobilization after revision total knee arthroplasty (TKA) remains unexplored in the literature despite its potential to address key challenges in the post-operative management and rehabilitation in these patients. Revision TKA is typically associated with higher rates of complications such as instability, malalignment, extensor mechanism disruption, and stiffness. Given the intricate nature of revision procedures and the increased risk of suboptimal outcomes, effective strategies for optimizing functional recovery and minimizing post-operative pain are critical. Semirigid extension bracing, a form of knee immobilization, has shown promise in primary TKA in improving pain management, promoting knee range of motion (ROM), and reducing opioid consumption. However, its role in revision TKA remains unknown. Exploring the use of knee immobilization in the revision TKA population could provide a non-pharmacological, cost-effective approach to addressing pain, minimizing complications, and improving long-term functional outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Knee immobilizerParticipants will wear a knee immobilizer brace for 10 days postoperatively and exclude knee range of motion exercises from postoperative physical therapy protocol during this period. They will resume all standard postoperative protocol after this period. |
| Control Group | Placebo comparator | Device: No Knee ImmobilizerParticipants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing revision TKA for aseptic indications including aseptic loosening, polyethylene wear, instability, malalignment, periprosthetic fracture.
- Patients undergoing revision TKA of one or both components.
Key exclusion criteria (8 listed)
- Patients who are undergoing revision TKA for stiffness.
- Patients with occult infection not recognized prior to revision.
- Patients with hinged TKA component reconstructions.
- Patients undergoing revision for liner exchange.
- History of VTE/PE.
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 immobilizerParticipants will wear a knee immobilizer brace for 10 days postoperatively and exclude knee range of motion exercises from postoperative physical therapy protocol during this period. They will resume all standard postoperative protocol after this period. | Device | Study Group |
| No Knee ImmobilizerParticipants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol. | Device | Control Group |
Primary outcome
Range of motion (degrees) - knee joint; measured using digital goniometer
Time frame: 3 months postoperatively
Active and Passive knee flexion and extension range of motion will be measured in degrees using a standardized digital goniometer at each timepoint.
11 secondary outcomes
Range of motion (degrees) - knee joint; measured using a digital goniometer
Time frame: 2 weeks, 6 weeks, and 1 year postoperatively
Swelling (mid-patellar circumference in centimeters) - knee joint; measured using a flexible measuring tape
Time frame: 2 weeks, 6 weeks, 3 months and 1 year postoperatively
Stiffness - Knee Joint
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year postoperatively
Wound complications
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year postoperatively
Time to achieve physical therapy milestones
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year
Knee Society Scale Score Delta
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year
Functional Knee Society Scale Score Delta
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year
KOOS Jr. Score Delta
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year
PROMIS-10 Score Delta
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year
VAS Pain Score Delta
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year
Total 90 day opioid consumption
Time frame: 90 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 34507367Tarazi JM, Chen Z, Scuderi GR, Mont MA. The Epidemiology of Revision Total Knee Arthroplasty. J Knee Surg. 2021 Nov;34(13):1396-1401. doi: 10.1055/s-0041-1735282. Epub 2021 Sep 10.
- Background: PubMed 29444666Postler A, Lutzner C, Beyer F, Tille E, Lutzner J. Analysis of Total Knee Arthroplasty revision causes. BMC Musculoskelet Disord. 2018 Feb 14;19(1):55. doi: 10.1186/s12891-018-1977-y.
- Background: PubMed 22810157Healy WL, Della Valle CJ, Iorio R, Berend KR, Cushner FD, Dalury DF, Lonner JH. Complications of total knee arthroplasty: standardized list and definitions of the Knee Society. Clin Orthop Relat Res. 2013 Jan;471(1):215-20. doi: 10.1007/s11999-012-2489-y.
- Background: PubMed 35587284Kaseb MH, Moharrami A, Mirghaderi SP, Fallah E, Razzaghof M, Moazen Jamshidi MM, Poopak A, Mortazavi SMJ. Effect of joint immobilization using extension splint immediately after total knee arthroplasty on post-operative knee function and pain: a randomized clinical trial. Int Orthop. 2022 Aug;46(8):1749-1759. doi: 10.1007/s00264-022-05428-8. Epub 2022 May 19.
- 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.
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 immobilizer and No Knee Immobilizer in people with Aseptic Revision Knee Arthroplasty and Stiffness Following Revision Knee Arthroplasty, run by Hospital for Special Surgery, New York 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 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (degrees) - knee joint; measured using digital goniometer (time frame: 3 months postoperatively). 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 NCT07552415, which also lists 4 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 24 Aug 2026.