Manipulation Under AnesthesiaPhase 4Colchine MUANCT02926248
Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement
A Phase 4 study testing Colchicine in people with Manipulation Under Anesthesia, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The specific aim of this study is to evaluate the effect of oral colchicine in primary TKA patients at 3 months following a manipulation under anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Manipulation Under Anesthesia
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Mar 2021
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary unilateral TKA indicated for MUA (knee flexion angle less than 90°)
- Primary Diagnosis of OA for TKA
- MUA indicated within 5 to 12 weeks of primary surgery
- Age greater than or equal to 18 years
- Patients with less than 10 degrees of a flexion contracture
Who cannot join
- Patients who are wheelchair bound
- Patients requiring concomitant arthroscopic or open procedures
- Revision TKA
- Patients requiring bilateral MUA
- Patients with renal disease (Creatinine > 1.5, and/or estimated creatinine clearance less than 30 mL/min)
- Patients with hepatic disease (known liver disease, cirrhosis, and/or AST/ALT>60)
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- Patients concurrently taking strong CYP3A4 inhibitors:
- Atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil
- Patients concurrently taking strong P-glycoprotein inhibitors:
- Cyclosporine, ranolazine
- Patients concurrently taking medications that increase the risk for myopathy and rhabdomyolysis:
- atorvastatin, fluvastatin, pravastatin, simvastatin, fibrates, gemfibrozil, digoxin
- Patients with a history of blood dyscrasias
- Pregnant patients
- Patients who are nursing mothers
- Patients with reported allergy to colchicine
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement: A Prospective Randomized Controlled Trial
The specific aim of this study is to evaluate the effect of oral colchicine in primary TKA patients at 3 months following a manipulation under anesthesia.
Read the detailed description
Adult primary unilateral TKA patients with less than 90° of knee flexion between 5 and 12 weeks after their index surgery will be screened for trial eligibility based on the inclusion and exclusion criteria above. Only patients from the protocol surgeons will be eligible to participate in this trial. MUA will be performed prior to 12 weeks after the index TKA. Patients will be randomized to either oral colchicine 0.6 mg twice daily for 6 weeks (treatment arm) or to oral placebo twice daily for 6 weeks in the placebo arm. All patients will follow a standardized post-MUA physical therapy protocol. Data will be collected prospectively, including study data collection sheets and medication diary. Other data sources will include office and inpatient medical records, operative reports, physical therapy records, hospital picture archiving and communication system (PACS) and radiology records. Outcomes will be collected at MUA, 6 weeks, 3 months, and 1 year.
- Conditions
- Manipulation Under Anesthesia
- Being tested
- Colchicine, Placebo
- Keywords
- Arthrofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Colcrys
Colchicine is an anti-fibrotic and anti-inflammatory drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Manipulation under Anesthesia (MUA) will be performed prior to 12 weeks after the index TKA. Patients will be randomized to oral colchicine 0.6 mg twice daily for 6 weeks. All patients will follow a standardized post-MUA physical therapy protocol. Receives: Drug: Colchicine |
| Placebo | Placebo comparator | Manipulation under Anesthesia (MUA) will be performed prior to 12 weeks after the index TKA. Patients will be randomized to oral placebo twice daily for 6 weeks. All patients will follow a standardized post-MUA physical therapy protocol. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Range of Motion
Measured in Degrees by a goniometer
Measured: Change from baseline to 3 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startMay 2016
- Primary completion21 Mar 2020
- Study completionMar 2021 (estimated)
Why it stopped: Continuing IRB review was not submitted. Study was inactivated with the institutional IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manipulation Under AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926248
- Sponsor's protocol ID
- 2015-707
- Acronym
- Colchine MUA
- Status last verified
- Jul 2020
- First submitted
- 24 Jun 2016
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02926248
- Acronym / sponsor ID
- Colchine MUA / 2015-707
- Conditions
- Manipulation Under Anesthesia
- Keywords
- Arthrofibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Continuing IRB review was not submitted. Study was inactivated with the institutional IRB.
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 21 Mar 2020 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 6 Oct 2016 (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 specific aim of this study is to evaluate the effect of oral colchicine in primary TKA patients at 3 months following a manipulation under anesthesia.
Detailed description
Adult primary unilateral TKA patients with less than 90° of knee flexion between 5 and 12 weeks after their index surgery will be screened for trial eligibility based on the inclusion and exclusion criteria above. Only patients from the protocol surgeons will be eligible to participate in this trial. MUA will be performed prior to 12 weeks after the index TKA. Patients will be randomized to either oral colchicine 0.6 mg twice daily for 6 weeks (treatment arm) or to oral placebo twice daily for 6 weeks in the placebo arm. All patients will follow a standardized post-MUA physical therapy protocol. Data will be collected prospectively, including study data collection sheets and medication diary. Other data sources will include office and inpatient medical records, operative reports, physical therapy records, hospital picture archiving and communication system (PACS) and radiology records. Outcomes will be collected at MUA, 6 weeks, 3 months, and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: ColchicineManipulation under Anesthesia (MUA) will be performed prior to 12 weeks after the index TKA. Patients will be randomized to oral colchicine 0.6 mg twice daily for 6 weeks. All patients will follow a standardized post-MUA physical therapy protocol. |
| Placebo | Placebo comparator | Other: PlaceboManipulation under Anesthesia (MUA) will be performed prior to 12 weeks after the index TKA. Patients will be randomized to oral placebo twice daily for 6 weeks. All patients will follow a standardized post-MUA physical therapy protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary unilateral TKA indicated for MUA (knee flexion angle less than 90°)
- Primary Diagnosis of OA for TKA
- MUA indicated within 5 to 12 weeks of primary surgery
- Age greater than or equal to 18 years
- Patients with less than 10 degrees of a flexion contracture
Key exclusion criteria (17 listed)
- Patients who are wheelchair bound
- Patients requiring concomitant arthroscopic or open procedures
- Revision TKA
- Patients requiring bilateral MUA
- Patients with renal disease (Creatinine > 1.5, and/or estimated creatinine clearance less than 30 mL/min)
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 |
|---|---|---|
| ColchicineAlso: ColcrysColchicine is an anti-fibrotic and anti-inflammatory drug | Drug | Colchicine |
| Placebo | Other | Placebo |
Primary outcome
Change in Range of Motion
Time frame: Change from baseline to 3 months post-operative
Measured in Degrees by a goniometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- 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 Phase 4 study testing Colchicine in people with Manipulation Under Anesthesia, 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 5 inclusion and 17 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: paused, as of the sponsor's last update on 28 Jul 2020. 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.
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?
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 Range of Motion (time frame: Change from baseline to 3 months post-operative). 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 28 Jul 2020.