NCT02540811

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2021

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

5.9 years

First QC Date

August 26, 2015

Last Update Submit

November 24, 2022

Conditions

Knee Injuries

Outcome Measures

Primary Outcomes (4)

  • Arthrometric measurement of knee joint laxity

    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

    Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

  • Lachman Test

    Clinical assessment of knee stability

    Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

  • Pivot Shift Test

    Clinical assessment of knee stability

    Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

  • Number of Participants With Treatment-Related Adverse Events

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

    Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Secondary Outcomes (2)

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

    Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

  • Evidence of integration of the investigational product by MRI

    Baseline, 3 months, 6 months, 12 months, 24 months

Study Arms (1)

dCELL® ACL Scaffold

EXPERIMENTAL
Device: dCELL® ACL Scaffold

Interventions

dCELL® ACL ScaffoldDEVICE
dCELL® ACL Scaffold

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Klinika Chirurgii Endoskopowej Sp. z o.o.

Żory, Ul. Bankowa 2, 44-240, Poland

Location

Med-Polonia Sp. z o.o.

Poznan, Ul. Obornicka 262, 60-406, Poland

Location

Hospital Infanta Elena de Madrid-Valdemoro

Madrid, Avd. Reyes Catolicos, 21, 28342, Spain

Location

Hospital Clinico San Carlos

Madrid, Calle Profesor Martin Lagos, 28001, Spain

Location

Hospital Universitario La Ribera de Alzira

Valencia, Carretera Corbera, Km1, 46600, Spain

Location

Hospital Universitari de Bellvitage

Barcelona, L'Hospilatet de Llobregat, 08907, Spain

Location

Clifton Park Hospital

York, North Yorkshire, YO30 5RA, United Kingdom

Location

Robert Jones and Agnes Hunt Hospital NHS Foundation Trust

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Simon Roberts

    The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 4, 2015

Study Start

September 1, 2015

Primary Completion

August 11, 2021

Study Completion

August 11, 2021

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

ES(4)GB(2)PL(2)