Rupture; Meniscus, Bucket HandleNCT01740232
Can a Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone?
A study testing trephination and Normal meniscal repair in people with Rupture; Meniscus, Bucket Handle, run by Mikkel Lindegaard Attrup at 2 sites in Denmark.
Trial summary
Meniscus does not always heal when sutured. The investigators will make small holes in the meniscus before repair to promote more bleeding. The investigators expect that will help the meniscus to heal better. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Rupture; Meniscus, Bucket Handle
- What is being tested?
- trephination and Normal meniscal repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2012to Nov 2016
- Phase
- Interventional
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults who have a meniscus repaired.
Who cannot join
- Meniscus not fit for repair.
- Patients not fit for the repair regime.
- Arthrosis > stadie 2 (ICRS).
- Prior attempt of repair of the meniscus.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Artroskopisk Center Amager
Copenhagen, 2300
Mikkel Attrup, +45 31494239, mikkel.attrup@regionh.dk
Mikkel Attrup
- Recruiting
Artroskopisk Center Amager
Copenhagen S, Copenhagen, 2300
Mikkel Attrup, +45 32 34 32 90, mikkel.attrup@regionH.dk
Mikkel Attrup
About this study
Official title: A Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone
Meniscus does not always heal when sutured. The investigators will make small holes in the meniscus before repair to promote more bleeding. The investigators expect that will help the meniscus to heal better.
Read the detailed description
RCT study to evaluate the effect on trephination together with meniscal repair on meniscus healing after repair.
- Conditions
- Rupture; Meniscus, Bucket Handle
- Being tested
- trephination, Normal meniscal repair
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trephinationProcedure or surgery
Artroscopic meniskal repair with trephination.
Normal meniscal repairProcedure or surgery
Also called Normal meniscal suture with FastFix device.
Artroscopic meniskal repair without trephination.
| Study group | Role | What they receive |
|---|---|---|
| Trephination | Active comparator | A 1 x 10 mm pricker are used for the trephination of the meniscus before normal meniscal repair. Receives: Procedure: trephination |
| Normal meniscal repair | Placebo comparator | standard operation. Normal meniscalrepair. Receives: Procedure: Normal meniscal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS Questionnaire
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
Measured: 4 month
KOOS Questionnaire
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
Measured: 12 month
Secondary outcomes (1)
Clinical meniscus healing
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture; Meniscus, Bucket HandleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mikkel Lindegaard Attrup
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mikkel Lindegaard Attrup, Amager Hospital
- Investigators
- Mikkel Attrup, Principal investigator, Artroscopic Center Amager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740232
- Sponsor's protocol ID
- meniskprojekt
- Other IDs
- H-4-2012-093
- Status last verified
- Jan 2015
- First submitted
- 12 Oct 2012
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone
- ClinicalTrials.gov ID
- NCT01740232
- Acronym / sponsor ID
- meniskprojekt
- Conditions
- Rupture; Meniscus, Bucket Handle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mikkel Lindegaard AttrupUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 4 Dec 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.
Meniscus does not always heal when sutured. The investigators will make small holes in the meniscus before repair to promote more bleeding. The investigators expect that will help the meniscus to heal better.
Detailed description
RCT study to evaluate the effect on trephination together with meniscal repair on meniscus healing after repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trephination | Active comparator | Procedure: trephinationA 1 x 10 mm pricker are used for the trephination of the meniscus before normal meniscal repair. |
| Normal meniscal repair | Placebo comparator | Procedure: Normal meniscal repairstandard operation. Normal meniscalrepair. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults who have a meniscus repaired.
Key exclusion criteria (4 listed)
- Meniscus not fit for repair.
- Patients not fit for the repair regime.
- Arthrosis > stadie 2 (ICRS).
- Prior attempt of repair of the meniscus.
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 |
|---|---|---|
| trephinationArtroscopic meniskal repair with trephination. | Procedure or surgery | Trephination |
| Normal meniscal repairAlso: Normal meniscal suture with FastFix device.Artroscopic meniskal repair without trephination. | Procedure or surgery | Normal meniscal repair |
Primary outcome
KOOS Questionnaire
Time frame: 4 month
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
KOOS Questionnaire
Time frame: 12 month
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
1 secondary outcome
Clinical meniscus healing
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
Related trials for Rupture; Meniscus, Bucket Handle
RecruitingObservational study
Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy
Meniscus Rupture, Meniscus Injury
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.
Mikkel Attrup principal investigator
Artroscopic Center Amager
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trephination and Normal meniscal repair in people with Rupture; Meniscus, Bucket Handle, run by Mikkel Lindegaard Attrup at 2 sites 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Jan 2015. 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 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. 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.
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?
Contact Mikkel Attrup (+4531494239, mikkel.attrup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS Questionnaire (time frame: 4 month). The study lists 2 primary outcomes in all. 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 15 Jan 2015.