OsteoarthritisNCT00492973
Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?
A study testing methylprednisolone acetate and active comparator in people with Osteoarthritis and Post-traumatic; Arthrosis, run by New Lexington Clinic at 1 site in United States.
Trial summary
Prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. One group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Osteoarthritis, Post-traumatic; Arthrosis
- What is being tested?
- methylprednisolone acetate and active comparator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Feb 2008
- Phase
- Interventional
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between ages of 18 and 95
- Has elected to undergo total knee replacement
Who cannot join
- Allergy to any of the medications used in the protocol
- History of kidney disease
- Rheumatoid arthritis
- Any systemic conditions associated with chronic pain
- History of deep knee sepsis in the affected extremity
- Unable to understand the questions used to obtain the Knee Society Score
- Minors and prisoners will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexington Clinic Sports Medicine Center
Lexington, Kentucky, 40504
About this study
Official title: Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty
Prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. One group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. A second group will get an injection in the knee during surgery that contains the same pain medications and antibiotic along with a corticosteroid to control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused with muscle-building anabolic steroids you may have heard about in the news. Each patient will have an equal chance of being in either of the two groups. This study will test the safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation following total knee replacement.
Read the detailed description
Information collected during your office visits:
The patient will be asked for a brief medical history so that we may determine if the patient can participate in the study. A member of our research team will ask the patient a series of questions about his/her knee. The patient will be asked to answer this series of questions a total of 4 times over the course of 1 year. Also, we will record how well the patient can bend and straighten your knee at these 4 office visits. We will have the patient rate the pain in his/her knee and ask the patient if he/she is satisfied with the surgery. If the patients have any complications, those will also be recorded. The patient will also have X-rays taken of the knee at the postoperative follow-up visits. This is the normal routine following total knee replacement. The X-rays will be read by the surgeon to help determine the success of the surgery.
Injection during total knee replacement surgery:
All patients will receive an injection containing bupivicaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline that will be placed directly into the knee during surgery. In addition, approximately half of the patients in the study will also receive methylprednisolone acetate as part of the injection.
Information being collected during your hospital stay:
During the hospital stay, information will be gathered for this study. A physical therapist will measure how well the patient can bend and straighten the knee. The amount of pain medication that was taken at the hospital will be recorded, and the number of days spent in the hospital will also be recorded.
- Conditions
- Osteoarthritis, Post-traumatic; Arthrosis
- Being tested
- methylprednisolone acetate, active comparator
- Keywords
- arthroplasty, replacement, knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylprednisolone acetateDrug
Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
active comparatorDrug
Also called bupivacaine HCl, morphine, epinephrine, clonidine
bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients in the active comparator group will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. Receives: Drug: active comparator |
| Corticosteroid | Experimental | Patients in the Corticosteroid group will have the same medications as the Control Group with the addition of a corticosteroid (methylprednisolone acetate) Receives: Drug: methylprednisolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Measured: days after surgery
Knee Range of Motion
Measured: 3 months
Knee Society Scores
The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion.
Measured: 3 months postoperative
Amount of Pain Medication Taken Per Day
Measured: Average of 3 days after surgery
Patient Satisfaction
Measured: 6 weeks, 3 months, and 1 year postoperative
Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
Measured: any point during the first postoperative year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startMar 2006
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Lexington Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Responsible party
- Sponsor
- Investigators
- Christian P Christensen, MD, Principal investigator, New Lexington Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492973
- Sponsor's protocol ID
- LCO.2006.2
- Status last verified
- Apr 2013
- First submitted
- 25 Jun 2007
- Last updated
- 19 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lombardi AV Jr, Berend KR, Mallory TH, Dodds KL, Adams JB. Soft tissue and intra-articular injection of bupivacaine, epinephrine, and morphine has a beneficial effect after total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):125-30. doi: 10.1097/01.blo.0000147701.24029.cc.
PubMed 15534532Parvataneni HK, Ranawat AS, Ranawat CS. The use of local periarticular injections in the management of postoperative pain after total hip and knee replacement: a multimodal approach. Instr Course Lect. 2007;56:125-31.
PubMed 17472300Christensen CP, Jacobs CA, Jennings HR. Effect of periarticular corticosteroid injections during total knee arthroplasty. A double-blind randomized trial. J Bone Joint Surg Am. 2009 Nov;91(11):2550-5. doi: 10.2106/JBJS.H.01501.
PubMed 19884426
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00492973
- Acronym / sponsor ID
- LCO.2006.2
- Conditions
- Osteoarthritis, Post-traumatic; Arthrosis
- Keywords
- arthroplasty, replacement, knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- New Lexington ClinicUniversity, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Study start
- Mar 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Posted 19 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. One group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. A second group will get an injection in the knee during surgery that contains the same pain medications and antibiotic along with a corticosteroid to control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused with muscle-building anabolic steroids you may have heard about in the news. Each patient will have an equal chance of being in either of the two groups. This study will test the safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation following total knee replacement.
Detailed description
Information collected during your office visits:
The patient will be asked for a brief medical history so that we may determine if the patient can participate in the study. A member of our research team will ask the patient a series of questions about his/her knee. The patient will be asked to answer this series of questions a total of 4 times over the course of 1 year. Also, we will record how well the patient can bend and straighten your knee at these 4 office visits. We will have the patient rate the pain in his/her knee and ask the patient if he/she is satisfied with the surgery. If the patients have any complications, those will also be recorded. The patient will also have X-rays taken of the knee at the postoperative follow-up visits. This is the normal routine following total knee replacement. The X-rays will be read by the surgeon to help determine the success of the surgery.
Injection during total knee replacement surgery:
All patients will receive an injection containing bupivicaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline that will be placed directly into the knee during surgery. In addition, approximately half of the patients in the study will also receive methylprednisolone acetate as part of the injection.
Information being collected during your hospital stay:
During the hospital stay, information will be gathered for this study. A physical therapist will measure how well the patient can bend and straighten the knee. The amount of pain medication that was taken at the hospital will be recorded, and the number of days spent in the hospital will also be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: active comparatorPatients in the active comparator group will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. |
| Corticosteroid | Experimental | Drug: methylprednisolone acetatePatients in the Corticosteroid group will have the same medications as the Control Group with the addition of a corticosteroid (methylprednisolone acetate) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between ages of 18 and 95
- Has elected to undergo total knee replacement
Key exclusion criteria (7 listed)
- Allergy to any of the medications used in the protocol
- History of kidney disease
- Rheumatoid arthritis
- Any systemic conditions associated with chronic pain
- History of deep knee sepsis in the affected extremity
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 |
|---|---|---|
| methylprednisolone acetateSame medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate | Drug | Corticosteroid |
| active comparatorAlso: bupivacaine HCl, morphine, epinephrine, clonidinebupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline | Drug | Control |
Primary outcome
Length of Hospital Stay
Time frame: days after surgery
Knee Range of Motion
Time frame: 3 months
Knee Society Scores
Time frame: 3 months postoperative
The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion.
Amount of Pain Medication Taken Per Day
Time frame: Average of 3 days after surgery
Patient Satisfaction
Time frame: 6 weeks, 3 months, and 1 year postoperative
Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
Time frame: any point during the first postoperative year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15534532Lombardi AV Jr, Berend KR, Mallory TH, Dodds KL, Adams JB. Soft tissue and intra-articular injection of bupivacaine, epinephrine, and morphine has a beneficial effect after total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):125-30. doi: 10.1097/01.blo.0000147701.24029.cc.
- Background: PubMed 17472300Parvataneni HK, Ranawat AS, Ranawat CS. The use of local periarticular injections in the management of postoperative pain after total hip and knee replacement: a multimodal approach. Instr Course Lect. 2007;56:125-31.
- Derived from this study: PubMed 19884426Christensen CP, Jacobs CA, Jennings HR. Effect of periarticular corticosteroid injections during total knee arthroplasty. A double-blind randomized trial. J Bone Joint Surg Am. 2009 Nov;91(11):2550-5. doi: 10.2106/JBJS.H.01501.
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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.
Christian P Christensen, MD principal investigator
New Lexington Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylprednisolone acetate and active comparator in people with Osteoarthritis and Post-traumatic; Arthrosis, run by New Lexington Clinic 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 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: finished, as of the sponsor's last update on 19 Dec 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?
Yes. Results are posted in the registry (first posted 19 Dec 2013). 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?
Length of Hospital Stay (time frame: days after surgery). The study lists 6 primary outcomes in all. 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 NCT00492973, which also lists 3 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 19 Dec 2013.