NCT04407364

Brief Summary

The objective of this prospective enrollment study is to collect data confirming safety, performance and clinical benefits of the CoMatryx Surgical Collagen powder at a minimum 1-year follow-up and compare it to a historical control group who did not receive the product at the time of surgery. The primary objective is to confirm safety and clinical benefits of the product. This will be assessed by recording the rate of wound healing and incidence and frequency of wound care related complications. Relationship of complications to the product should be specified.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

May 20, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

3.6 years

First QC Date

May 20, 2020

Last Update Submit

July 3, 2024

Conditions

Surgical Wound, Healed

Outcome Measures

Primary Outcomes (2)

  • CoMatryx Surgical Bovine Collagen

    The primary objective is to confirm safety and performance of the study product. This will be assessed by recording the rate of healing, incidence and frequency of complications and adverse events relative to the surgical incision at 1-week, 2-week, 6-week, 6-month and 1-year follow-up. Height and Weight will be combined as BMI(kg/m\^2)

    This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.

  • CoMatryx Surgical Bovine Collagen Height and Weight

    Height and Weight will be combined as BMI(kg/m\^2)

    This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.

Secondary Outcomes (1)

  • Bovine Collagen

    This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.

Study Arms (2)

Intervention Cohort

The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen

Device: CoMatryx Surgical Bovine Collagen

Historical Cohort

Primary and Revision total hip arthroplasty patients between 18-85 years of age

Device: CoMatryx Surgical Bovine Collagen

Interventions

CoMatryx Surgical Bovine CollagenDEVICE

The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen

Also known as: Interventional Cohort, Historical Cohort with no intervention
Historical CohortIntervention Cohort

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary and Revision total hip arthroplasty patients between 18-85 years of age

You may qualify if:

  • Subjects must be 18 years of age or older
  • Subject must be willing and able to sign IRB approved informed consent
  • Subject must have a BMI of 35 or higher
  • Surgical approach of only ASI (anterior supine)
  • Primary total hip arthroplasty
  • Revision total hip arthroplasty

You may not qualify if:

  • Subjects more than 85 years of age
  • Subjects who will be or have undergone bilateral total hip replacements
  • Subject is known to be pregnant or nursing
  • Subject is an alcohol or drug abuser
  • Subject has a psychiatric illness or cognitive deficit that will not allow for proper informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Center for Joint Replacement

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Kwame Ennin, MD

    Texas Health Physicians Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 29, 2020

Study Start

September 2, 2020

Primary Completion

April 2, 2024

Study Completion

May 2, 2025

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)