OsteoarthritisPhase 4HTO_painsNCT01537146
Local Infiltration Versus Block Against Pains After High Tibial Osteotomy
A Phase 4 study testing Ropivacaine in people with Osteoarthritis and Malalignment, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee can be treated more appropriately, so that both healing and rehabilitation are served optimally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Malalignment
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Dec 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned primary open-wedge high tibia osteotomy
- Patients (male/female) ≥ 18 år
- Patients giving written informed consent and authority.
- Patients receiving epidural anaesthesia
Who cannot join
- Patients with intolerance to trial medications
- Rejection of or contraindicated epidural anaesthesia
- Patients with rheumatoid arthritis.
- Patients with Body Mass Index (BMI) ≥ 35
- Patients that do not read or write Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Clinik Farsoe, Aalborg University Hospital
Farsø, Northern Jutland
About this study
Official title: Examination of the LIA (Local Infiltration) Versus Regional Blockade as Pain Management for Open-wedge High Tibial Osteotomy
The purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee can be treated more appropriately, so that both healing and rehabilitation are served optimally.
Read the detailed description
Axis corrective surgery of the knee is an attractive alternative to the knee prosthesis in young active patients with unilateral osteoarthritis of the knee. The purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee pain can be treated more appropriately, so that both healing and rehabilitation are served optimally.
Proximal open-wedge tibia osteotomy is an accepted treatment option for younger patients with unilateral osteoarthritis of knee. 70 such operations are performed in the investigators Orthopaedic Divisions each year. The surgery involves cutting through the upper end of the tibia and opens the bone using specialized instruments. The tibia is lengthened on the medial side with the purpose of correcting the mechanical axis of the knee joint. The surgery is associated with many pains in the early postoperative phase. Until now, pain treatment has been controlled with either epidural block, or regional block via femoral catheter. Both treatments may involve risks such as loss of strength and sensibility disturbance, which often prolongs the early recovery and mobilization. Moreover, pain treatment administered via femoral catheter is often not sufficient as a part of the area behind the knee joint is not covered.
With the advent of new pain therapies, particularly intra operative administration of local anaesthetics directly in the operating field and catheter administration for postoperative pain management, there is hope that those disadvantages are eliminated. By ensuring an effective pain treatment and the possibility of early mobilization only hours after completion of surgery, this will allow for better patient care in terms of reduced pain, shorter hospitalization and quicker rehabilitation.
New results show that the healing of bone opening is not compromised by rapid mobilization. The migration of bone parts around the opening is measured by roentgen stereometric analysis (RSA), with a precision of approximately 0.2 mm. This verifies stable healing of the bone opening.
- Conditions
- Osteoarthritis, Malalignment
- Being tested
- Ropivacaine
- Keywords
- unicompartmental, osteoarthritis, varus, malalignment, opening wedge, HTO, high, tibia, osteotomy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called No other names
Bolus infusion via catheter/6H for 24H
RopivacaineDrug
Also called no other names
Intra operational bolus infusion. Bolus infusion via catheter /6H for 24H
| Study group | Role | What they receive |
|---|---|---|
| Femoral Block | Active comparator | Not described Receives: Drug: Ropivacaine |
| Local Infiltration Anagesia | Active comparator | Not described Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PN morphine consumption
Use of morphine recorded in medicine journal
Measured: Hours (up to 24 hours)
Secondary outcomes (4)
Pain
Level of pain experienced by the patient, recorded by NRS (numerical rank scale)
Measured: Hours (up to 24 hours)
Knee Function
Knee function in the patient, measured by KOOS questionnaire
Measured: Months (up to 16 months)
General Health Parameters
General Health Parameters, measured by EQ-5D questionnaire
Measured: Months (up to 16 months)
Stability in the osteotomy
Stability in the opening-wedge osteotomy, measured with RSA (Rontgen Stereometric Analysis)
Measured: Months (up to 16 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startApr 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders C Laursen, MD, Principal investigator, Northern Orthopaedic Division, DenmarkMogens B Laursen, MD, PhD, Study chair, Northern Orthopaedic Division, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537146
- Sponsor's protocol ID
- ON-04-019-ACL
- Acronym
- HTO_pains
- Status last verified
- Jan 2016
- First submitted
- 2 Aug 2011
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the LIA (Local Infiltration) Versus Regional Blockade as Pain Management for Open-wedge High Tibial Osteotomy
- ClinicalTrials.gov ID
- NCT01537146
- Acronym / sponsor ID
- HTO_pains / ON-04-019-ACL
- Conditions
- Osteoarthritis, Malalignment
- Keywords
- unicompartmental, osteoarthritis, varus, malalignment, opening wedge, HTO, high, tibia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Feb 2012 (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 purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee can be treated more appropriately, so that both healing and rehabilitation are served optimally.
Detailed description
Axis corrective surgery of the knee is an attractive alternative to the knee prosthesis in young active patients with unilateral osteoarthritis of the knee. The purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee pain can be treated more appropriately, so that both healing and rehabilitation are served optimally.
Proximal open-wedge tibia osteotomy is an accepted treatment option for younger patients with unilateral osteoarthritis of knee. 70 such operations are performed in the investigators Orthopaedic Divisions each year. The surgery involves cutting through the upper end of the tibia and opens the bone using specialized instruments. The tibia is lengthened on the medial side with the purpose of correcting the mechanical axis of the knee joint. The surgery is associated with many pains in the early postoperative phase. Until now, pain treatment has been controlled with either epidural block, or regional block via femoral catheter. Both treatments may involve risks such as loss of strength and sensibility disturbance, which often prolongs the early recovery and mobilization. Moreover, pain treatment administered via femoral catheter is often not sufficient as a part of the area behind the knee joint is not covered.
With the advent of new pain therapies, particularly intra operative administration of local anaesthetics directly in the operating field and catheter administration for postoperative pain management, there is hope that those disadvantages are eliminated. By ensuring an effective pain treatment and the possibility of early mobilization only hours after completion of surgery, this will allow for better patient care in terms of reduced pain, shorter hospitalization and quicker rehabilitation.
New results show that the healing of bone opening is not compromised by rapid mobilization. The migration of bone parts around the opening is measured by roentgen stereometric analysis (RSA), with a precision of approximately 0.2 mm. This verifies stable healing of the bone opening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Block | Active comparator | Drug: Ropivacaine |
| Local Infiltration Anagesia | Active comparator | Drug: Ropivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned primary open-wedge high tibia osteotomy
- Patients (male/female) ≥ 18 år
- Patients giving written informed consent and authority.
- Patients receiving epidural anaesthesia
Key exclusion criteria (5 listed)
- Patients with intolerance to trial medications
- Rejection of or contraindicated epidural anaesthesia
- Patients with rheumatoid arthritis.
- Patients with Body Mass Index (BMI) ≥ 35
- Patients that do not read or write Danish
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 |
|---|---|---|
| RopivacaineAlso: No other namesBolus infusion via catheter/6H for 24H | Drug | Femoral Block |
| RopivacaineAlso: no other namesIntra operational bolus infusion. Bolus infusion via catheter /6H for 24H | Drug | Local Infiltration Anagesia |
Primary outcome
PN morphine consumption
Time frame: Hours (up to 24 hours)
Use of morphine recorded in medicine journal
4 secondary outcomes
Pain
Time frame: Hours (up to 24 hours)
Knee Function
Time frame: Months (up to 16 months)
General Health Parameters
Time frame: Months (up to 16 months)
Stability in the osteotomy
Time frame: Months (up to 16 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
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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.
Anders C Laursen, MD principal investigator
Northern Orthopaedic Division, Denmark
Mogens B Laursen, MD, PhD study chair
Northern Orthopaedic Division, Denmark
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 Ropivacaine in people with Osteoarthritis and Malalignment, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 4 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 22 Jan 2016. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PN morphine consumption (time frame: Hours (up to 24 hours)). 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 22 Jan 2016.