Clinical trial NCT02540811: Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament
Official title: A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Lead sponsor: Tissue Regenix Ltd
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have been implanted with the investigational product following a ruptured anterior cruciate ligament (ACL) of the knee.

Detailed description: The dCELL® ACL Scaffold is a novel device manufactured from porcine tissue using a patented variation of Tissue Regenix's platform technology to render the tissue biocompatible and free from cellular material, providing a biological scaffold that is safe for human implantation whilst preserving the biomechanical properties.

The device is used to reconstruct traumatic ACL tears to help restore normal knee function and therefore prevent further wear of the cartilage and future damage.

Eligibility criteria: Inclusion Criteria:

* Patients with partial or complete tear of the ACL and require reconstruction of the ACL.
* Medial Collateral Ligament (MCL) injury grade 2 or less.
* Osteoarthritis grade 2 or less on the Kellgren Lawrence scale.
* Patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol.

Exclusion Criteria:

* Body Mass Index (BMI) greater than 35 kg/m2.
* Treatment with any investigational drug or device within two months prior to screening.
* Patients presenting with abnormal degenerative osteoarthritis of the joint.
* Previous ACL reconstruction on the target knee.
* Current ACL injury on contralateral knee.
* Patients using anticoagulants within 2 weeks prior to surgery.
* Patients on current immuno-suppressive or radiation therapy within six months of screening.
* Patients with diabetes or cardiovascular disease which precludes elective surgery.
* Patients with documented renal disease or metabolic bone disease.

Primary outcomes:
measure: Arthrometric measurement of knee joint laxity
timeFrame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Lachman Test
timeFrame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Pivot Shift Test
timeFrame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary outcomes:
measure: Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function
timeFrame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Evidence of integration of the investigational product by MRI
timeFrame: Baseline, 3 months, 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Zory
country: Poland
facility: Klinika Chirurgii Endoskopowej Sp. z o.o.
state: Ul. Bankowa 2
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o.o.
state: Ul. Obornicka 262
city: Madrid
country: Spain
facility: Hospital Infanta Elena de Madrid-Valdemoro
state: Avd. Reyes Catolicos, 21
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: Calle Profesor Martin Lagos
city: Valencia
country: Spain
facility: Hospital Universitario La Ribera de Alzira
state: Carretera Corbera, Km1
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitage
state: L'Hospilatet De Llobregat
city: York
country: United Kingdom
facility: Clifton Park Hospital
state: North Yorkshire
city: Oswestry
country: United Kingdom
facility: Robert Jones and Agnes Hunt Hospital NHS Foundation Trust
state: Shropshire
Study officials:
affiliation: The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
name: Simon Roberts
role: PRINCIPAL_INVESTIGATOR
References: