Adjustable or fixed loops in ACL surgery The GAP Study
Research type
Research Study
Full title
A Prospective, Randomised Study Investigating the use of a Fixed Loop versus an Adjustable Suspensory Loop in Anterior Cruciate Ligament Reconstruction - a Comparison of Clinical and Functional Outcome. The GAP Study.
IRAS ID
225470
Contact name
Christopher Gardner
Contact email
Sponsor organisation
RD+E Hospital NHSFT
Duration of Study in the UK
5 years, 8 months, 1 days
Research summary
The anterior cruciate ligament (ACL) is one of the major stabilising ligaments in the knee. If torn, younger and sportier patients will often have this ligament reconstructed to allow them to return to sport with a knee joint that they can trust.
Hamstring tendons are taken from the back of the knee and create a graft to replace the torn ACL. A tunnel is drilled in the lower end of the thigh bone, and the upper end of the shin bone and the graft passes through this. On the shin bone side it is fixed in place using a screw. In the thigh bone, it is attached to a device known as a suspensory loop which passes through the tunnel and is held in place via a small metal button.
The length of the graft and the tunnels in the bone vary. It is important to get a good length of the graft material in both. With the fixed loop system, once the metal button attached to the thigh bone is in place, the length of the loop cannot be adjusted and the amount of hamstring graft in the bone tunnels cannot be changed. The adjustable loop allows the amount of graft in either bone tunnel to vary to ensure sufficient graft is accurately placed.
Patients for inclusion will be identified by their surgeon and if they consent will be randomly allocated to receive one of the 2 ACL reconstruction options as outlined above. We will monitor their progress for 2 years after the operation examining the results with questionnaires to measure how well the patients feel their knee is performing, and tests to measure knee function. All aspects of their surgical care will be as routine practice apart from the decision to use an adjustable or fixed suspensory loop.REC name
Wales REC 1
REC reference
17/WA/0169
Date of REC Opinion
13 Jun 2017
REC opinion
Further Information Favourable Opinion