NCT03321812

Brief Summary

The trial evaluates the clinical efficacy and safety of decalcification bone scaffold for cartilage lesions of the knee. Half of participants will receive decalcification bone scaffold combined with microfracture, while the other will only receive microfracture as a control group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

September 11, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

5.3 years

First QC Date

October 23, 2017

Last Update Submit

June 30, 2020

Conditions

Cartilage Injury

Keywords

decalcification bone scaffoldmicrofracturerandomized controlled trialcartilage lesions of the knee

Outcome Measures

Primary Outcomes (1)

  • Appraise of magnetic reasonance imaging

    Evaluate the articular cartilage postoperatively by MRI.

    5 years

Secondary Outcomes (4)

  • Lysholm score

    5 years

  • International Knee Documentation Committee (IKDC) 2000

    5 years

  • Tegner activity level score

    5 years

  • Visual analogue scale

    5 years

Study Arms (2)

decalcification bone scaffold

EXPERIMENTAL

Decalcification bone scaffold is a novel tissue engineered acellular matrix scaffold with the closest biomechanics and structure to normal cartilage.

Procedure: decalcification bone scaffoldProcedure: microfracture

Microfracture

ACTIVE COMPARATOR

Microfracture is a conventional treatment for cartilage lesions of the knee.

Procedure: microfracture

Interventions

decalcification bone scaffoldPROCEDURE

Decalcification bone scaffold is a tissue engineering acellular matrix scaffold with the closest biomechanics and structure of normal cartilage.

decalcification bone scaffold
microfracturePROCEDURE

Microfracture is the surgical option for conventional treatment of cartilage defects.

Microfracturedecalcification bone scaffold

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old, male or female
  • Cartilage defect 2-8 cm²
  • Subjects have the surgical indication of microfracture and no contradiction
  • Subjects participate the clinical trial voluntarily, and sign informed consent
  • Subjects could comply with follow-up

You may not qualify if:

  • Participated in other drug or medical device clinical trials in the last 6 months.
  • Can not accept allogeneic decalcified bone due to religion, ethnic and other issues.
  • Defect area 2 cm² or 8 cm² or lack of normal cartilage tissue around defect zone.
  • Complex multi-ligament injury
  • Suffered from systemic immune disease or systemic, locally infected
  • Joint fibrosis, joint rigidity, mobility was significantly limited
  • Moderate and severe osteoarthritis
  • With contraindications to MRI
  • Hemophilia
  • General condition can not tolerate surgery
  • Pregnant or planned pregnant women and lactating women
  • With abnormal spirit and selfless ability
  • Other circumstances judged by doctors that can not participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Yingfang Ao, MD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoqing Hu, phd

CONTACT

+8613401096777aoyingfang@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Institute of Sports Medicine , Principal Investigator, Clinical Professor of Orthopedic Sports Medicine

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 26, 2017

Study Start

September 11, 2018

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

July 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)