Arthroscopic Anterior Cruciate Ligament ReconstructionPhase 4NCT01448278
Pain Evaluation After Anterior Cruciate Ligament (ACL) Ligamentoplasty
A Phase 4 study testing "All-inside" and Classical technique in people with Arthroscopic Anterior Cruciate Ligament Reconstruction, run by Hospital Ambroise Paré Paris at 1 site in France.
Trial summary
The "All-inside" method is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation. In the so-called "classical" method, the fixation is achieved with interference screws. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopic Anterior Cruciate Ligament Reconstruction
- What is being tested?
- "All-inside" and Classical technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Apr 2012
- 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
- Total or partial tear of the Anterior Cruciate Ligament
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country.
France1 site
Ambroise Paré Hospital
Boulogne-Billancourt, Île-de-France Region, 92100
About this study
Official title: Pain Evaluation After ACL Ligamentoplasty: "All-inside" Versus Classical Technique. A Prospective Randomised Comparative Study
The "All-inside" method is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation. In the so-called "classical" method, the fixation is achieved with interference screws.
The hypothesis of this study was that the "All-inside" technique causes less pain than the conventional technique. The main objective was to evaluate the immediate postoperative pain for the first ten days and at one month from the intervention.
- Being tested
- "All-inside", Classical technique
- Keywords
- Anterior cruciate ligament, Arthroscopy, Incomplete bone tunnels, Anterior cruciate ligament reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"All-inside"Procedure or surgery
The "All-inside" technique is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation.
Classical techniqueProcedure or surgery
The Classical technique is a usual procedure for anterior cruciate ligament reconstruction (ACL). The fixation is achieved with interference screws.
| Study group | Role | What they receive |
|---|---|---|
| All-inside technique | Experimental | Not described Receives: Procedure: "All-inside" |
| Classical technique | Active comparator | Not described Receives: Procedure: Classical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment on a Visual Analogical Scale
Measured: One month after surgery
Secondary outcomes (5)
Pain assessment on a Visual Analogical Scale
Measured: First ten days
Analgesics consumption
Measured: First ten days
Functional evaluation with IKDC score
Measured: Change from base-line in IKDC objective score at 6 months
Discharge of crutches and orthesis
Measured: Time frame from surgery
Radiographic analysis of tunnels positioning according to Aglietti's criteria
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroscopic Anterior Cruciate Ligament ReconstructionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
- Investigators
- Philippe Hardy, Ph.D., Principal investigator, Hospital Ambroise Paré ParisHorea Benea, MD, Study director, Ambroise Paré HospitalHenri d'Astorg, MD, Study director, Ambroise Paré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448278
- Sponsor's protocol ID
- APR112010
- Status last verified
- Feb 2015
- First submitted
- 4 Oct 2011
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Benea H, d'Astorg H, Klouche S, Bauer T, Tomoaia G, Hardy P. Pain evaluation after all-inside anterior cruciate ligament reconstruction and short term functional results of a prospective randomized study. Knee. 2014 Jan;21(1):102-6. doi: 10.1016/j.knee.2013.09.006. Epub 2013 Oct 5.
PubMed 24269603
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Evaluation After ACL Ligamentoplasty: "All-inside" Versus Classical Technique. A Prospective Randomised Comparative Study
- ClinicalTrials.gov ID
- NCT01448278
- Acronym / sponsor ID
- APR112010
- Keywords
- Anterior cruciate ligament, Arthroscopy, Incomplete bone tunnels, Anterior cruciate ligament reconstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Oct 2011 (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 "All-inside" method is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation. In the so-called "classical" method, the fixation is achieved with interference screws.
The hypothesis of this study was that the "All-inside" technique causes less pain than the conventional technique. The main objective was to evaluate the immediate postoperative pain for the first ten days and at one month from the intervention.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All-inside technique | Experimental | Procedure: "All-inside" |
| Classical technique | Active comparator | Procedure: Classical technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total or partial tear of the Anterior Cruciate Ligament
Key exclusion criteria (1 listed)
- Patient refusal
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 |
|---|---|---|
| "All-inside"The "All-inside" technique is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation. | Procedure or surgery | All-inside technique |
| Classical techniqueThe Classical technique is a usual procedure for anterior cruciate ligament reconstruction (ACL). The fixation is achieved with interference screws. | Procedure or surgery | Classical technique |
Primary outcome
Pain assessment on a Visual Analogical Scale
Time frame: One month after surgery
5 secondary outcomes
Pain assessment on a Visual Analogical Scale
Time frame: First ten days
Analgesics consumption
Time frame: First ten days
Functional evaluation with IKDC score
Time frame: Change from base-line in IKDC objective score at 6 months
Discharge of crutches and orthesis
Time frame: Time frame from surgery
Radiographic analysis of tunnels positioning according to Aglietti's criteria
Time frame: One month after surgery
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 9 Feb 2015.
- Derived from this study: PubMed 24269603Benea H, d'Astorg H, Klouche S, Bauer T, Tomoaia G, Hardy P. Pain evaluation after all-inside anterior cruciate ligament reconstruction and short term functional results of a prospective randomized study. Knee. 2014 Jan;21(1):102-6. doi: 10.1016/j.knee.2013.09.006. Epub 2013 Oct 5.
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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.
Philippe Hardy, Ph.D. principal investigator
Hospital Ambroise Paré Paris
Horea Benea, MD study director
Ambroise Paré Hospital
Henri d'Astorg, MD study director
Ambroise Paré Hospital
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 "All-inside" and Classical technique in people with Arthroscopic Anterior Cruciate Ligament Reconstruction, run by Hospital Ambroise Paré Paris at 1 site in France.
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 1 inclusion and 1 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 9 Feb 2015. 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 France. 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?
Pain assessment on a Visual Analogical Scale (time frame: One month after surgery). 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 NCT01448278, which also lists 1 linked publication.
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 9 Feb 2015.