Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434837
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2007-02-09
Brief Title:
Initial Graft Tension and ACL Surgery
Sponsor:
Rhode Island Hospital
Organization:
Rhode Island Hospital
Study Overview
Official Title:
Effects of Initial Graft Tension on Anterior Cruciate Ligament Reconstruction
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The anterior cruciate ligament ACL is one of four strong ligaments connecting the bones of the knee joint If overstretched the ACL can tear Reconstruction of a torn ACL is now a common surgical procedure The amount of tension applied to the ACL during reconstruction may indirectly affect the possible onset of arthritis over time The purpose of this study is to determine the effect of initial graft tension set during ACL reconstruction surgery on the progression of knee arthritis over at least a 15-year period
Detailed Description:
Damage to the ACL is a common injury that usually requires surgical reconstruction to restore function and prevent progression of post-traumatic osteoarthritis However the reconstruction procedure frequently causes degenerative changes to the knee joint over time The amount of tension applied to the ACL during reconstruction may indirectly affect the possible onset of arthritis over time High tension would result in less joint motion during the initial healing stages which may make the onset of arthritis less likely On the other hand high tension would result in increased compressive forces between the joint surfaces which could lead to arthritis The purpose of this study is to evaluate the effect of initial graft tension set during ACL reconstruction surgery on joint cartilage and the development of knee arthritis over at least a 15-year period
Participants will include candidates for ACL reconstruction surgery using patellar tendon grafts Participants will be randomly assigned to one of two treatment groups
Low tension Group 1 participants will receive low-tension treatment with initial graft tension set so that the anterior-posterior A-P displacement of the reconstructed knee is equal to that of the uninjured knee
High-tension Group 2 participants will receive high-tension treatment with initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee
Participants will enroll in this 15-year study 1 to 6 weeks prior to ACL surgery There will be two preoperative study visits one will include magnetic resonance imaging MRI and the other will include a knee evaluation dynamic function testing and questionnaires Postoperative visits occurred immediately following surgery and at 6 12 36 60 84 120 144 and 180 months following surgery Strength testing functional testing x-rays questionnaires and a knee exam will occur at most postoperative visits MRIs will occur at some postoperative visits An additional group of participants with no evidence of knee injury will serve as a control The control group will attend all study visits except for the 12-month visit All participants may be followed for up to 15 years
Participants will include candidates for ACL reconstruction surgery using patellar tendon grafts Participants will be randomly assigned to one of two treatment groups
Low tension Group 1 participants will receive low-tension treatment with initial graft tension set so that the anterior-posterior A-P displacement of the reconstructed knee is equal to that of the uninjured knee
High-tension Group 2 participants will receive high-tension treatment with initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee
Participants will enroll in this 15-year study 1 to 6 weeks prior to ACL surgery There will be two preoperative study visits one will include magnetic resonance imaging MRI and the other will include a knee evaluation dynamic function testing and questionnaires Postoperative visits occurred immediately following surgery and at 6 12 36 60 84 120 144 and 180 months following surgery Strength testing functional testing x-rays questionnaires and a knee exam will occur at most postoperative visits MRIs will occur at some postoperative visits An additional group of participants with no evidence of knee injury will serve as a control The control group will attend all study visits except for the 12-month visit All participants may be followed for up to 15 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR074973 | NIH | None | httpsreporternihgovquickSearchR01AR074973 |
| R01AR047910 | NIH | None | None |