Jewel ACL Study
Research type
Research Study
Full title
Randomised controlled trial comparing the outcomes of the auto graft ACL reconstruction (using hamstring tendon) to an artificial ACL reconstruction (Jewel ACL)
IRAS ID
186827
Contact name
Andrew Gray
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
7571, R&D reference number
Duration of Study in the UK
10 years, 6 months, 29 days
Research summary
The anterior cruciate ligament (ACL) is a band of tissue joining the thigh bone to the shin bone, and it helps to maintain anterior stability of the knee joint and helps to control the back and forth movement of the lower leg. This ligament can be damaged due to sports injuries or trauma. When the ACL is torn, the knee becomes very unstable and loses its range of movement.
This condition is surgically treated by reconstruction using grafting new tissue into it. This is done by removing what remains of the torn ligament and replacing it with a tendon from the hamstring or the patellar tendon.
An artificial ligament (Jewel ACL) as an alternate to using tendon graft has the potential benefit of preventing donor site morbidity and also biomechanically superior. Also it helps in reduced surgical time of approximately 10-15 minutes (25% of surgical time).
We aim to study the outcomes surgery using an artificial Jewel ACL reconstruction against using auto-graft ACL reconstruction by a randomized controlled trial.
The study will aim to recruit 80 patients (40 treated with autograft and 40 with Jewel ACL) over an 18 month period.
Patients 18 years and over, who present with ACL tear and instability of the knee requiring and ACL reconstruction surgery under the care of principal or co-investigator will be eligible for the study .Patients who refuse to take part, not able to provide informed consent, cognitive problems, other injuries to lower limb impacting routine rehabilitation, morbidly obese and patients unable to attend rehabilitation and clinic appointments at Freeman hospital will be excluded.
Patients will be assessed using clinical assessment, questionnaires and walking analysis pre-operatively and at 2, 6, 12, 24 and 52 weeks post-surgery and postal questionnaires will be sent at 2,5 and 10 years post-operatively.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0380
Date of REC Opinion
24 Nov 2015
REC opinion
Favourable Opinion