Comparing the JewelACL artificial hybrid graft with a tendon graft for ACL reconstruction

The Jewel ACL study: Feasibility randomised controlled Trial comparing the outcomes of the auto graft ACL reconstruction (using hamstring tendon) to a hybrid artificial (JewelACL) and autograft ACL reconstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91866211

Enrollment

Registered

2020-02-12

Start date

2024-01-01

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior cruciate ligament (ACL) reconstruction Surgery

Interventions

Current interventions as of 13/02/2024: Each participant will have a near-normal journey through the NHS system when having surgery for ACL reconstruction. They will initially be seen in clinic after

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 13/02/2024: 1. Persistent knee instability after ACL rupture that merits surgical intervention and ligament reconstruction 2. Listed at the Northern Care Alliance for routine unilateral ACL reconstruction 3. Aged 18 years and over Previous inclusion criteria: 1. Persistent knee instability after ACL rupture that merits surgical intervention and ligament reconstruction 2. Listed at Pennine for routine unilateral ACL reconstruction 3. Aged 18 years and over

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 13/02/2024: 1. Refusal to participate 2. Inability to provide informed consent 3. Inability to answer questionnaires for cognitive reasons 4. Morbidly obese (BMI >40 kg/m2) 5. Patient is unable to attend rehabilitation and clinic appointments at the hospital or at the UoS 6. Revision ACL surgery 7. Previous hamstring injury or harvest procedure Previous exclusion criteria: 1. Refusal to participate 2. Inability to provide informed consent 3. Inability to answer questionnaires for cognitive reasons 4. Morbidly obese (BMI >40 kg/m2) 5. Patient is unable to attend rehabilitation and clinic appointments at the hospital or at MIHP 6. Revision ACL surgery 7. Previous hamstring injury or harvest procedure

Design outcomes

Primary

Measure	Time frame
Patient's assessment of knee function using the International Knee Documentation Committee (IKDC) Questionnaire at 2, 6, 12, 26 and 39 weeks and 1 year, 18 months and 2 years post-surgery	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 13/02/2024: 1. Pain assessed using the short form McGill pain questionnaire on the day of surgery and at 2 and 6 weeks post-surgery 2. Knee laxity assessed using the Genourob device at 3, 6, 9 and 12 months 3. Knee function assessed using 3-dimensional gait analysis at a Salford University laboratory with sensors at 3, 6, 9 and 12 months post-operatively. This will include walking, running, knee bend and hop tests. Previous secondary outcome measures: 1. Pain assessed using the short form McGill pain questionnaire on the day of surgery and at 2 and 6 weeks post-surgery 2. Knee laxity assessed using the Genourob device at 3, 6, 9 and 12 months 3. Knee function assessed using 3-dimensional gait analysis at a Salford University laboratory with sensors at 6 months and 12 months post-operatively. This will include walking, running, knee bend and hop tests.	—

Measure

Time frame

Current secondary outcome measures as of 13/02/2024: 1. Pain assessed using the short form McGill pain questionnaire on the day of surgery and at 2 and 6 weeks post-surgery 2. Knee laxity assessed using the Genourob device at 3, 6, 9 and 12 months 3. Knee function assessed using 3-dimensional gait analysis at a Salford University laboratory with sensors at 3, 6, 9 and 12 months post-operatively. This will include walking, running, knee bend and hop tests. Previous secondary outcome measures: 1. Pain assessed using the short form McGill pain questionnaire on the day of surgery and at 2 and 6 weeks post-surgery 2. Knee laxity assessed using the Genourob device at 3, 6, 9 and 12 months 3. Knee function assessed using 3-dimensional gait analysis at a Salford University laboratory with sensors at 6 months and 12 months post-operatively. This will include walking, running, knee bend and hop tests.

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 1, 2026