Stiffness Following Total Knee ArthroplastyPhase 4MUANCT02739035
MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty
A Phase 4 study testing Dexamethasone and Celecoxib in people with Stiffness Following Total Knee Arthroplasty, run by Mayo Clinic at 16 sites in United States.
Trial summary
Compare the outcome following manipulation under anesthesia for stiffness in a randomized controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time of manipulation to a control group receiving manipulation alone. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stiffness Following Total Knee Arthroplasty
- What is being tested?
- Dexamethasone and Celecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 16 sitesUnited States
- Study dates
- Apr 2016to Dec 2022
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have received a primary unilateral TKA for a diagnosis of osteoarthritis.
- MUA's scheduled between 6-10 weeks postoperatively
Who cannot join
- Intolerance to NSAIDs
- Renal dysfunction
- Age < 18 or > 90 years
- Primary diagnosis of rheumatoid arthritis
- Patients with a Glomerular Filtration Rate (GFR) <60 as the cut off for Chronic Kidney Disease (CKD) (stage 3 CKD)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
OrthoCarolina
Charlotte, North Carolina, 28207
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
Colorado Joint Replacement
Denver, Colorado, 80210
Duke University Medical Ceter, Dept. of Orthopaedics
Durham, North Carolina, 27710
Houston Methodist
Houston, Texas, 77030
Rothman Institute
Lansdale, Pennsylvania, 19446
HipKnee Arkansas Foundation
Little Rock, Arkansas, 72205
Joint Implant Surgeons
New Albany, Ohio, 43054
Hospital for Joint Diseases
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
New York - Presbyterian at Columbia University
New York, New York, 10032
Univ. of Nebraska Medical Center
Omaha, Nebraska, 68198
Aria 3B Orthopaedic Specialists
Philadelphia, Pennsylvania, 19106
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Manipulation Under Anesthesia (MUA) to Treat Postoperative Stiffness After Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial
Compare the outcome following manipulation under anesthesia for stiffness in a randomized controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time of manipulation to a control group receiving manipulation alone.
Outcomes will include pain, range of motion, as well as subjective outcome scores.
Read the detailed description
Stiffness is a potential complication following Total Knee Arthroplasty (TKA). While a variety of factors have been cited as possible causes, such as component malrotation or improper soft-tissue balancing, however, an etiology is not always appreciated. Histologic and arthroscopic evidence of fibrosis suggests that an inflammatory process may contribute to loss of knee range of motion following surgery. Manipulation under anesthesia remains standard of care for stiffness following TKA. Manipulation shows improved range of motion for stiffness after total knee arthroplasty, however, patients do not always achieve full range of motion. Furthermore, repeat manipulation and manipulation greater than 8 weeks post-surgically have shown limited improvements. Given a possible role of the host inflammatory response and the importance of early gains in knee range of motion following total knee arthroplasty, limiting the inflammatory response at the time of manipulation may improve outcomes. Investigators would like to assess the role of anti-inflammatory medications to optimize range of motion and outcome for manipulation under anesthesia for stiffness following TKA.
- Being tested
- Dexamethasone, Celecoxib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
8 mg of IV dexamethasone immediately before MUA.
CelecoxibDrug
Also called Celebrex
2 weeks per mouth of celecoxib (200 mg daily)
| Study group | Role | What they receive |
|---|---|---|
| MUA alone | No intervention | Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. |
| MUA with dexamethasone and celecoxib | Experimental | For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Receives: Drug: Dexamethasone; Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Range of Motion After Manipulation Under Anesthesia
Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.
Measured: 6 weeks after manipulation
Knee Range of Motion After Manipulation Under Anesthesia
Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.
Measured: 1 year from the date of the manipulation
Secondary outcomes (17)
Knee Society Functional Score
The Knee Society Functional score was developed by the Knee Society as a method of evaluating how well a patient can use their joint. Knee function was evaluated in two categories: walking, and stair usage. Points range from 0-100. 0 = extreme problems, 100 = no problems.
In each category, points range from 0-50, where 0 = extreme problems to 50 = no problems. Total scores are 0-100 with lower scores indicating extreme knee function problems and higher scores indicating no knee function problems.
Measured: 6 weeks after the MUA, and 1 year after the MUA
Knee Society Knee Score
The Knee Society Knee Score is method of joint evaluation developed by the Knee Society to measure the condition of a patient's knee. Knee condition was evaluated in three categories: pain, range of motion, and stability. Points range from 0-100. 0 = extreme problems, 100 = no problems.
Up to 50 points for pain, 25 points for range of motion, and 25 points for stability. Deductions occur for Extension lag, flexion contracture, malalignment, and pain at rest.
Measured: 6 weeks after the MUA, and 1 year after the MUA
Short Form Survey 12-item Version 2 (SF-12v2): Physical Health
The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better physical health.
Measured: 6 weeks after the MUA, and 1 year after the MUA
Short Form Survey 12-item Version 2 (SF-12v2): Mental Health
The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better mental health.
Measured: 6 weeks after MUA, 1 Year after MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score
The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Measured: 6 weeks after the MUA, and 1 year after the MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score
The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Measured: 6 weeks after the MUA, and 1 year after the MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score
The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Measured: 6 weeks after MUA, 1 year after MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score
The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Measured: 6 weeks after MUA, 1 year after MUA
Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life
The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Measured: 6 weeks after MUA, 1 year after MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR)
KOOS JR is a questionnaire designed to measure outcomes for patients with knee replacements. Questions focus on knee stiffness, pain, and function for daily activities. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Measured: 6 weeks after the MUA, and 1 year after the MUA
PROMIS-29 Outcome Form: Physical Function
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For physical function, higher scores indicate better function.
Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Measured: 6 weeks after the MUA, and 1 year after the MUA
PROMIS-29 Outcome Form: Anxiety
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For anxiety, lower scores indicate less anxiety.
Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Measured: 6 weeks after MUA, and 1 year after MUA
PROMIS-29 Outcome Form: Depression
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For depression, lower scores indicate fewer depressive symptoms.
Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Measured: 6 weeks after MUA, and 1 year after MUA
PROMIS-29 Outcome Form: Fatigue
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For fatigue, lower scores indicate less fatigue.
Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Measured: 6 weeks after MUA, and 1 year after MUA
PROMIS-29 Outcome Form: Sleep Disturbance
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For sleep disturbance, lower scores indicate less sleep disturbance.
Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Measured: 6 weeks after MUA, and 1 year after MUA
PROMIS-29 Outcome Form: Social Activities
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For social activities, higher scores indicate a better ability to participate in social roles and activities.
Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Measured: 6 weeks after MUA, and 1 year after MUA
PROMIS-29 Outcome Form: Pain Interference
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For pain interference, higher scores indicate more frequent interference in activities due to pain.
Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Measured: 6 weeks after MUA, 1 year after MUA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2022
- Study completionDec 2022
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.
- Other trials for Stiffness Following Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Knee Society
- Responsible party
- Principal investigator, Matthew P. Abdel, M.D., Mayo Clinic
- Investigators
- Abdel Matthew, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739035
- Sponsor's protocol ID
- 15-009075
- Acronym
- MUA
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2016
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulation Under Anesthesia (MUA) to Treat Postoperative Stiffness After Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02739035
- Acronym / sponsor ID
- MUA / 15-009075
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Knee Society
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the outcome following manipulation under anesthesia for stiffness in a randomized controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time of manipulation to a control group receiving manipulation alone.
Outcomes will include pain, range of motion, as well as subjective outcome scores.
Detailed description
Stiffness is a potential complication following Total Knee Arthroplasty (TKA). While a variety of factors have been cited as possible causes, such as component malrotation or improper soft-tissue balancing, however, an etiology is not always appreciated. Histologic and arthroscopic evidence of fibrosis suggests that an inflammatory process may contribute to loss of knee range of motion following surgery. Manipulation under anesthesia remains standard of care for stiffness following TKA. Manipulation shows improved range of motion for stiffness after total knee arthroplasty, however, patients do not always achieve full range of motion. Furthermore, repeat manipulation and manipulation greater than 8 weeks post-surgically have shown limited improvements. Given a possible role of the host inflammatory response and the importance of early gains in knee range of motion following total knee arthroplasty, limiting the inflammatory response at the time of manipulation may improve outcomes. Investigators would like to assess the role of anti-inflammatory medications to optimize range of motion and outcome for manipulation under anesthesia for stiffness following TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MUA alone | No intervention | –Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. |
| MUA with dexamethasone and celecoxib | Experimental | Drug: Dexamethasone, Drug: CelecoxibFor subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have received a primary unilateral TKA for a diagnosis of osteoarthritis.
- MUA's scheduled between 6-10 weeks postoperatively
Key exclusion criteria (5 listed)
- Intolerance to NSAIDs
- Renal dysfunction
- Age < 18 or > 90 years
- Primary diagnosis of rheumatoid arthritis
- Patients with a Glomerular Filtration Rate (GFR) <60 as the cut off for Chronic Kidney Disease (CKD) (stage 3 CKD)
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 |
|---|---|---|
| DexamethasoneAlso: Decadron8 mg of IV dexamethasone immediately before MUA. | Drug | MUA with dexamethasone and celecoxib |
| CelecoxibAlso: Celebrex2 weeks per mouth of celecoxib (200 mg daily) | Drug | MUA with dexamethasone and celecoxib |
Primary outcome
Knee Range of Motion After Manipulation Under Anesthesia
Time frame: 6 weeks after manipulation
Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.
Knee Range of Motion After Manipulation Under Anesthesia
Time frame: 1 year from the date of the manipulation
Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.
17 secondary outcomes
Knee Society Functional Score
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Knee Society Knee Score
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Short Form Survey 12-item Version 2 (SF-12v2): Physical Health
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Short Form Survey 12-item Version 2 (SF-12v2): Mental Health
Time frame: 6 weeks after MUA, 1 Year after MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score
Time frame: 6 weeks after MUA, 1 year after MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score
Time frame: 6 weeks after MUA, 1 year after MUA
Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life
Time frame: 6 weeks after MUA, 1 year after MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR)
Time frame: 6 weeks after the MUA, and 1 year after the MUA
PROMIS-29 Outcome Form: Physical Function
Time frame: 6 weeks after the MUA, and 1 year after the MUA
PROMIS-29 Outcome Form: Anxiety
Time frame: 6 weeks after MUA, and 1 year after MUA
PROMIS-29 Outcome Form: Depression
Time frame: 6 weeks after MUA, and 1 year after MUA
PROMIS-29 Outcome Form: Fatigue
Time frame: 6 weeks after MUA, and 1 year after MUA
PROMIS-29 Outcome Form: Sleep Disturbance
Time frame: 6 weeks after MUA, and 1 year after MUA
PROMIS-29 Outcome Form: Social Activities
Time frame: 6 weeks after MUA, and 1 year after MUA
PROMIS-29 Outcome Form: Pain Interference
Time frame: 6 weeks after MUA, 1 year after MUA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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RecruitingPhase 4
Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia
Knee Stiffness After Total Knee Arthroplasty
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.
Abdel Matthew, M.D. principal investigator
Mayo Clinic
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Celecoxib in people with Stiffness Following Total Knee Arthroplasty, run by Mayo Clinic at 16 sites 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 5 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2023). 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 Range of Motion After Manipulation Under Anesthesia (time frame: 6 weeks after manipulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.