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| ID | Type | Description | Link |
|---|---|---|---|
| H-4-2012-093 | Other Identifier | Committee on Health Research Ethics |
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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.
RCT study to evaluate the effect on trephination together with meniscal repair on meniscus healing after repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trephination | Active Comparator | A 1 x 10 mm pricker are used for the trephination of the meniscus before normal meniscal repair. |
|
| Normal meniscal repair | Placebo Comparator | standard operation. Normal meniscalrepair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trephination | Procedure | Artroscopic meniskal repair with trephination. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS Questionnaire | Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire. | 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. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical meniscus healing | 4 month |
| Measure | Description | Time Frame |
|---|---|---|
| Lysholm | Lysholm questionnaire | 4 month |
| rearthroscopy | 6 month | |
| KOOS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikkel Attrup | Contact | +4531494239 | mikkel.attrup@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Mikkel Attrup | Artroscopic Center Amager | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artroskopisk Center Amager | Recruiting | Copenhagen S | Copenhagen | 2300 | Denmark |
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| ID | Term |
|---|---|
| D012421 | Rupture |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014207 | Trephining |
| ID | Term |
|---|---|
| D003399 | Craniotomy |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Normal meniscal repair |
| Procedure |
Artroscopic meniskal repair without trephination. |
|
|
Differences between the to arms in the complete KOOS questionnaire. |
| 12 month |
| Lysholm | Lysholm questionnaire | 12 month |
| IKDC | IKDC questionnaire | 12 month |
| IKDC | IKDC questionnaire | 4 month |
| KOOS | Differences between the to arms in the complete KOOS questionnaire. | 4 month |
| Artroskopisk Center Amager | Not yet recruiting | Copenhagen | 2300 | Denmark |
|