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Completed

NCT Number: NCT02540811

Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament

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.

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Key information

Conditions

Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinika Chirurgii Endoskopowej Sp. z o.o., Żory, Ul. Bankowa 2, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dCELL® ACL Scaffold

Device

Primary outcomes

  1. Arthrometric measurement of knee joint laxity

    Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

    Comparison of the magnitude of side-to-side differences in mm between the treated knee and the opposite normal knee using an arthrometric ligament testing device

  2. Lachman Test

    Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

    Clinical assessment of knee stability

  3. Pivot Shift Test

    Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

    Clinical assessment of knee stability

  4. Number of Participants With Treatment-Related Adverse Events

    Time frame: Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

    The frequency and seriousness of any adverse events or adverse device effects will be assessed

Secondary outcomes

  1. Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function

    Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

    Patient's subjective score of 1 to 100 points, with 100 implying the best results and 1 the worst results

  2. Evidence of integration of the investigational product by MRI

    Time frame: Baseline, 3 months, 6 months, 12 months, 24 months

    Changes to the articular cartilage or joint space at follow up time points compared to pre-surgery

Sponsors and collaborators

Lead sponsor

Tissue Regenix Ltd

Industry

Registry information

Official study title

A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2015
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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