NCT04889443

Brief Summary

SHARC is an observational study of cartilage patients who are treated with surgery that involves obtaining a harvest biopsy. SHARC will study the natural healing process of the harvest biopsy site based on histological and biochemical analyses of repair tissue biopsies, synovial fluid biomarkers, medical imaging (MRI) and gait analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2018

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

5.3 years

First QC Date

May 7, 2021

Last Update Submit

March 12, 2024

Conditions

Cartilage DamageCartilage Injury

Keywords

Cartilage repair

Outcome Measures

Primary Outcomes (1)

  • Fraction of hyaline cartilage in harvest repair tissue

    Fraction of hyaline or mixed hyaline/fibrous cartilage in a 1-year biopsy assessed using OsScore cartilage histology criteria

    1 year after tissue harvest

Secondary Outcomes (10)

  • Visual quality of the repair tissue in harvest repair tissue

    1 year after tissue harvest

  • Quality of harvest repair tissue assessed from MRI images

    1 year after tissue harvest

  • Mean signal intensity of harvest repair tissue on MRI

    1 year after tissue harvest

  • Quality of harvest repair tissue assessed from a biopsy using the ICRS-II histology score

    1 year after tissue harvest

  • Quality of harvest repair tissue assessed from a biopsy using the OsScore histology score

    1 year after tissue harvest

  • +5 more secondary outcomes

Interventions

Surgical cartilage repair procedure requiring harvest procedure or Autologous Stromal Cell ImplantationPROCEDURE

Any surgical cartilage repair procedure of the knee that requires a harvest biopsy of knee cartilage, which will leave a controlled small cartilage injury

Also known as: Autologous Chondrocyte Implantation (ACI), Matrix Assisted Chondrocyte Implantation (MACI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery that involves the harvest of cartilage tissue as part of the treatment

You may qualify if:

  • Being able to provide signed and dated informed consent form.
  • Scheduled for one of the following surgical treatments
  • Surgery that involves the harvest of cartilage tissue as part of the treatment, thus creating a fresh cartilage defect, which is then left to heal naturally. Examples of such surgery are autologous chondrocyte implantation (ACI) and mosaicplasty.
  • Autologous stromal cell implantation (ASCI), as part of the ASCOT randomised clinical trial.

You may not qualify if:

  • Inadequate understanding of verbal explanations or written information given in English, or having special communication needs.
  • Chronic severe renal insufficiency
  • Anything that would preclude the individual's full compliance with or completion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RJAH Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cartilage repair tissue biopsy

Study Officials

  • Jan Herman Kuiper, PhD

    Keele University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 17, 2021

Study Start

September 1, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

After the study end and publication of results, individual data will be available upon request to the PI. No patient identifiable information will be shared. All individual data will be link-anonymized and a minimum of 3-way anonymization of relevant data will be used to ensure that participants cannot be identified from the supplied data.

Shared Documents
STUDY PROTOCOL
Time Frame
After the study end and after the study results have been published
Access Criteria
The access will adhere to Keele University's Research Data Management Policy. Briefly, a data-sharing agreement must be issued and signed by appropriate authorities before data are released or analyses are performed on behalf of the requester. The Data-sharing agreement will prohibit any attempt to (a) identify study participants from the released data or otherwise breach confidentiality, (b) make unapproved contact with study participants.

Locations

GB(1)