Total Knee and Total Hip ArthroplastyPhase 3NCT00307853
TRAUMEEL for Pain After Total Knee/Hip Arthroplasty
A Phase 3 study testing Traumeel S in people with Total Knee and Total Hip Arthroplasty, run by Shaare Zedek Medical Center at 2 sites in Israel.
Trial summary
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption following Total Knee or Hip Arthroplasty. 224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee and Total Hip Arthroplasty
- What is being tested?
- Traumeel S
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 2 sitesIsrael
- Study dates
- Aug 2008to Aug 2009
- Phase
- Phase 3
- 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
- Patients of either sex undergoing unilateral THAP or TKAP.
- Age over 18 years.
- Signature upon informed consent form
Who cannot join
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Refused to give verbal consent to the telephone interviews
- Impossibility to be reached during the 14-17 days post operative
- Inability to comply with the study protocol for any other reason
- Previous major surgical procedure on ipsilateral leg.
- Current use of analgesics for any other reason.
Show all 10Show fewer
- A history of chronic pain syndrome.
- Abused legal or illicit drug use.
- Hypersensitivity to botanicals of the Compositae family
- Known sensitivity to paracetamol, codeine or tramadol.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, 91031
Department of Orthopedics, Meir Medical Center
Kfar Saba
About this study
Official title: A Randomised, Double - Blind, Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Pain After Total Knee and Total Hip Arthroplasty.
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption following Total Knee or Hip Arthroplasty.
224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. Baseline measurements of relevant outcome measures will taken preoperatively.
In the recovery room, the patient will begin to receive IV Dipyrone (Optalgin) 1000mg, for a total of 4 doses during the first 24 hours postoperatively (1000 mg every 6 hours). Once back in the ward, the patient will be connected to an IV Patient-Controlled Analgesia (PCA) device, enabling the self-administration of morphine at a set dose of 1mg every 8 minutes, should the patient require it. The PCA memory registers the time and dose, and the data will be used later to evaluate post-operative pain.
- Conditions
- Total Knee and Total Hip Arthroplasty
- Being tested
- Traumeel S, Placebo
- Keywords
- homeopathy, pain, traumeel s, total knee arthroplasty, total hip arthroplasty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumeel SDrug
All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.
Traumeel SOther
All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.
PlaceboOther
All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | TraumeelS Receives: Drug: Traumeel S; Other: Traumeel S |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device
Measured: 48h
Secondary outcomes (9)
AUC of NRS scores for days 14-17.
Measured: 14-17d
Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device
Measured: 24h
Number of primary oral analgesic tablets ingested between days 14-17
Measured: 14-17d
ESR and hs-CPR at three and six days and six weeks
Measured: 6d and 3weeks
IL-6 at three and six days
Measured: 3 and 6d
Post operative blood loss
Measured: postoperative period
WOMAC
Measured: 6 weeks
Safety of post operative treatment
Measured: 6 weeks
Development of acute confusional state in the postoperative period
Measured: 14-17d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startAug 2008
- Primary completionAug 2009 (estimated)
Why it stopped: lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee and Total Hip ArthroplastyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Menachem Oberbaum, MD, Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307853
- Sponsor's protocol ID
- AP 06
- Status last verified
- Oct 2009
- First submitted
- 27 Mar 2006
- Last updated
- 20 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double - Blind, Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Pain After Total Knee and Total Hip Arthroplasty.
- ClinicalTrials.gov ID
- NCT00307853
- Acronym / sponsor ID
- AP 06
- Conditions
- Total Knee and Total Hip Arthroplasty
- Keywords
- homeopathy, pain, traumeel s, total knee arthroplasty, total hip arthroplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patients
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (estimated)
- First posted
- 28 Mar 2006 (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.
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption following Total Knee or Hip Arthroplasty.
224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. Baseline measurements of relevant outcome measures will taken preoperatively.
In the recovery room, the patient will begin to receive IV Dipyrone (Optalgin) 1000mg, for a total of 4 doses during the first 24 hours postoperatively (1000 mg every 6 hours). Once back in the ward, the patient will be connected to an IV Patient-Controlled Analgesia (PCA) device, enabling the self-administration of morphine at a set dose of 1mg every 8 minutes, should the patient require it. The PCA memory registers the time and dose, and the data will be used later to evaluate post-operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Traumeel S, Other: Traumeel STraumeelS |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of either sex undergoing unilateral THAP or TKAP.
- Age over 18 years.
- Signature upon informed consent form
Key exclusion criteria (10 listed)
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Refused to give verbal consent to the telephone interviews
- Impossibility to be reached during the 14-17 days post operative
- Inability to comply with the study protocol for any other reason
- Previous major surgical procedure on ipsilateral leg.
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 |
|---|---|---|
| Traumeel SAll patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day. | Drug | 1 |
| Traumeel SAll patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day. | Other | 1 |
| PlaceboAll patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day. | Other | Placebo |
Primary outcome
Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device
Time frame: 48h
9 secondary outcomes
AUC of NRS scores for days 14-17.
Time frame: 14-17d
Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device
Time frame: 24h
Number of primary oral analgesic tablets ingested between days 14-17
Time frame: 14-17d
ESR and hs-CPR at three and six days and six weeks
Time frame: 6d and 3weeks
IL-6 at three and six days
Time frame: 3 and 6d
Post operative blood loss
Time frame: postoperative period
WOMAC
Time frame: 6 weeks
Safety of post operative treatment
Time frame: 6 weeks
Development of acute confusional state in the postoperative period
Time frame: 14-17d
Results and safety
The study was stopped early (reason given: lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
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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.
Menachem Oberbaum, MD principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traumeel S in people with Total Knee and Total Hip Arthroplasty, run by Shaare Zedek Medical Center at 2 sites in Israel.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of patients). 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?
Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device (time frame: 48h). 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 20 Oct 2009.