Bone Healing Accelerant (BHA) Versus Autologous Bone Graf... | NCT06258499

Studies
Bone Healing Accelerant (BHA) Versus Autologous Bone Grafting (ABG) for Hindfoot or Ankle Arthrodesis

NCT06258499

Sponsor

Carmell Therapeutics Corporation

Status

Withdrawn

Last Update Posted

Feb 14, 2024Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Foot Deformities

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study never started and is on hold until further notice

Expanded Access Info

Start Date

Mar 2024Estimated

Primary Completion Date

Sep 2024Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Feb 6, 2024

First Submission Date that Met QC Criteria

Feb 6, 2024

First Posted Date

Feb 14, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2024

Last Update Posted Date

Feb 14, 2024Actual

Description Module

Brief Summary

This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle joint) during fusion surgery. It is hypothesized that by 6 months, the number of subjects with successful bone fusion will be greater in the BHA-treated group compared to subjects treated with standard of care alone.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BHA	Experimental	Subjects treated with BHA + standard of care	Combination Product: BHA
Control	No Intervention	Subjects treated as per standard of care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BHA	Combination Product	BHA active ingredients include a blood-derived component and beta-tricalcium phosphate. It is manually placed into the joint fusion space during fusion surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful Radiographic Fusion	Greater than or equal to 50% bone bridging across joint space for the full complement of joints fused as determined by CT in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.	24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient has pain with weight-bearing in the joint(s) below that, in the opinion of the Investigator, warrants arthrodesis:
1. Tibiotalar (ankle)
2. Talocalcaneal (subtalar)
3. Talonavicular
4. Calcaneocuboid
5. Double hindfoot (e.g., talonavicular and talocalcaneal joints)
6. Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints
Joint space(s) can, in the opinion of the Investigator, be adequately filled with no more than 9 cc of graft material (BHA or ABG)
Each fused joint can be adequately compressed and rigidly stabilized with plates, screws, staples or a combination thereof. External fixation, percutaneous Kirschner wires or intramedullary rods may not be used.
Patient is willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations.
If patient is a woman of childbearing bearing potential (not post-menopausal for 12 months or surgically sterile), patient has a urine pregnancy test with a negative result at screening and on the day of surgery, prior to the procedure. These trial participants must commit to adequate birth control through the 52-week follow-up

Exclusion Criteria:

Skeletally immature patients (i.e., radiographic evidence of open physes), regardless of age
Bone deficit, defect or void requiring a structural graft
Condition requiring intramedullary nailing or external fixation for the arthrodesis
Condition requiring osteotomy or fusion of any midfoot joints.
Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joints.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000840	Anisoles
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D010647