Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rosenborgklinikken | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this randomized controlled trial the investigators will compare the results after primary anterior cruciate ligament (ACL) reconstruction using two different methods for femoral fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become available and the clinical results have been described as promising; however, no randomized controlled trials comparing these two femoral fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method.
The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.
Primary anterior cruciate ligament (ACL) reconstructions with bone-patellar tendon-bone (BPTB) autografts have recently been found to have a lower risk of revision compared with hamstring tendon autografts, and BPTB has again become our graft of choice. Interference screws have been the standard method for fixing the femoral side of a BPTB graft; however problems such as damage of the graft and failure due to nonparallel screw placement have been reported. Cortical fixation using a suspensory system has been used for soft-tissue graft fixation for several years, and a corresponding device, the Endobutton CL BTB Fixation System (Smith & Nephew, Inc., Andover, MA, USA), has become available for fixation of bone-tendon-bone grafts. The clinical results after fixation with the Endobutton CL BTB have been described as promising; however, no randomized controlled trials comparing these two fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method.
In this randomized controlled trial, patients undergoing primary ACL reconstruction will be randomized into either an Endobutton group or an interference screw group. The primary aim of the study is to compare these two fixation methods, assessed by patient reported outcomes, laxity, range of motion and muscle strength. Knee related quality of life 2 years after surgery is the primary outcome, measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) subscale "knee related Quality of life (QOL)". Other aims are to see if there is any difference in the integration of the bone block in the femoral tunnel assessed by CT scan, in the risk of developing osteoarthritis assessed by radiographs, or in the risk of a postoperative complication or revision. The patients will be followed up 6 weeks, 6 months, 2 years and 10 years after surgery. CT scan will be performed after 6 months, and radiographs after 2 years and 10 years. In addition details of the rehabilitation will be recorded. Patients undergoing a revision will be followed up but excluded from further comparisons in the study.
Our hypothesis is that there is no difference in the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation, both with a metal interference screw for the tibial fixation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endobutton CL BTB | Experimental | Femoral fixation of the BPTB autograft with the Endobutton CL BTB Fixation System. |
|
| Metal interference screw | Active Comparator | Femoral fixation of the BPTB autograft with a metal interference screw. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobutton CL BTB | Device | ACL reconstruction with Endobutton CL BTB |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Knee related quality of life | KOOS subscale "knee related Quality of life (QOL)" | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tegner activity scale | 6 months, 2 years, 10 years | |
| Lachman test | Anterior translation of the tibia | 6 weeks, 6 months, 2 years, 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Registration | Up to 10 years |
| Reoperations | Registration | Up to 10 years |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trond Olav Lundemo, md | Contact | TrondOlav.Lundemo@helse-nordtrondelag.no | ||
| Tone Gifstad, md phd | Contact | tone.gifstad@stolav.no |
| Name | Affiliation | Role |
|---|---|---|
| Jon Olav Drogset, md phd | St. Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedic Surgery, St Olavs Hospital | Recruiting | Trondheim | Norway | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Metal interference screw |
| Device |
ACL reconstruction with metal interference screw |
|
| Muscular strength | Biodex dynamometer | 6 months, 2 years, 10 years |
| Bone block integration | CT scan | 6 months |
| Osteoarthritis | X-ray radiographs | 2 years, 10 years |
| Range of motion | 6 weeks, 6 months, 2 years, 10 years |
| Knee related quality of life | KOOS subscale "knee related Quality of life (QOL)" | 6 weeks |
| Knee related quality of life | KOOS subscale "knee related Quality of life (QOL)" | 6 months |
| Knee related quality of life | KOOS subscale "knee related Quality of life (QOL)" | 10 years |
| Lysholm functional knee score | 6 weeks, 6 months, 2 years, 10 years |
| KOOS | Knee injury and Osteoarthritis Outcome Score | 6 weeks, 6 months, 2 years, 10 years |
| Pivot shift test | Anteroposterior and rotational stability | 6 weeks, 6 months, 2 years, 10 years |
| KT-1000 arthrometer | Anterior translation of the tibia | 6 weeks, 6 months, 2 years, 10 years |
| Rosenborgklinikken |
| Recruiting |
| Trondheim |
| Norway |
|