Synthetic Cartilage Implant vs Osteochondral Autograft Transfer for Advanced 1st Metatarsal Phalangeal Joint Arthritis
Primary Purpose
Metatarsophalangeal Joint Arthritis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Synthetic Cartilage Implant
Osteochondral Autograft Transfer
Sponsored by
About this trial
This is an interventional treatment trial for Metatarsophalangeal Joint Arthritis focused on measuring Metatarsophalangeal Joint, Arthritis, Synthetic Cartilage Implant, Cartiva, Osteochondral Autograft Transfer
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 18 and 80 years old
- Grade 2 or 3 hallux rigidus based on Coughlin and Shurnas classification
- Presence of good bone stock as determined on pre-operative x-rays not requiring bone grafting
- Capable of consenting for self
Exclusion Criteria:
- Patients <18 years of age
- Grade 1 or 4 hallux rigidus based on Coughlin and Shurnas classification
- Active bacterial infection of the foot
- Previous bilateral total knee arthroplasty
- Previous fracture or significant trauma to the ipsilateral knee
- Inflammatory anthropathy
- Gout
- Inadequate bone stock
- Previous anthrodesis or arthroplasty performed on the ipsilateral first MTP
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Synthetic Cartilage Implant
Osteochondral Autograft Transfer
Arm Description
Participants receive the synthetic cartilage implant. The synthetic cartilage implant that will be used is the Cartiva implant.
Participants receive the current standard osteochondral autograft transfer procedure.
Outcomes
Primary Outcome Measures
Range of Motion
Pre-operative and post-operative clinical range of motion of the first MTP joint
Patient's Pain Level
Pre-operative and post-operative visual analog pain scale
Secondary Outcome Measures
Patient's Quality of Life
Foot and Ankle Ability Measure (FAAM) sports score uses patient-report to determine function
Clinically-Assessed Foot and Ankle Function
American Orthopedic Foot and Ankle Score (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale
Health Status
12-item short form health survey, use of concomitant medications, and changes in health status
Surgical Complications
Fractures, nerve injuries, blood loss, infection, etc.
Implant Failure
Failure of the Cartiva Synthetic Cartilage Implant
Secondary Surgical Intervention
Additional subsequent procedures, including removal, reoperation, revision, or supplemental fixation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03489876
Brief Title
Synthetic Cartilage Implant vs Osteochondral Autograft Transfer for Advanced 1st Metatarsal Phalangeal Joint Arthritis
Official Title
Comparison of Synthetic Cartilage Implant Versus Osteochondral Autologous Transfer for Advanced Hallux Rigidus, A Prospective Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of patient enrollment.
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. This data will allow for accurate comparisons between the two groups in regards to functional outcome, clinical outcome, pain relief, and complications.
Detailed Description
First MTP joint arthritis or hallux rigidus is the most common arthritic condition of the foot. Historically, there have been several options to treat this condition surgically, but the current standard for advanced hallux rigidus is first MTP anthrodesis. Newer joint preserving procedures offer patients effective relief of pain and improving functional outcomes as well as maintaining, and potentially improving, range of motion for the first MTP joint. Osteochondral autograft transfer has been shown to be an effective treatment for hallux rigidus, and involves harvesting a small cylindrical osteochondral graft from a site remote of the first MTP joint and transferring the graft to the head of the first metatarsal. A new synthetic cartilage implant, Cartiva, has been shown to have equivalent functional outcomes, pain scores, and complications to anthrodesis, but the first MTP range of motion in the Cartiva group was maintained or even improved in some patients.
This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. The hypothesis is that clinical range of motion, pain scores, subjective clinical outcomes, and complications will not be clinically inferior with the synthetic cartilage implant group compared to the osteochondral autograft transfer group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metatarsophalangeal Joint Arthritis
Keywords
Metatarsophalangeal Joint, Arthritis, Synthetic Cartilage Implant, Cartiva, Osteochondral Autograft Transfer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Upon eligibility verification and informed consent, computer-based randomization will allot patients into one of the two treatment groups, either synthetic cartilage implant or osteochondral autograft transfer.
Masking
None (Open Label)
Masking Description
The computer-based randomization sequence will be concealed from investigators using REDCap.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synthetic Cartilage Implant
Arm Type
Experimental
Arm Description
Participants receive the synthetic cartilage implant. The synthetic cartilage implant that will be used is the Cartiva implant.
Arm Title
Osteochondral Autograft Transfer
Arm Type
Active Comparator
Arm Description
Participants receive the current standard osteochondral autograft transfer procedure.
Intervention Type
Device
Intervention Name(s)
Synthetic Cartilage Implant
Other Intervention Name(s)
Cartiva
Intervention Description
The Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations.
Intervention Type
Procedure
Intervention Name(s)
Osteochondral Autograft Transfer
Intervention Description
The osteochondral autograft transfer will be harvested from the ipsilateral lateral femoral condyle (or contralateral if a previous ipsilateral total knee anthroplasty or trauma) and the graft will be transferred to the first metatarsal head.
Primary Outcome Measure Information:
Title
Range of Motion
Description
Pre-operative and post-operative clinical range of motion of the first MTP joint
Time Frame
2 years
Title
Patient's Pain Level
Description
Pre-operative and post-operative visual analog pain scale
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patient's Quality of Life
Description
Foot and Ankle Ability Measure (FAAM) sports score uses patient-report to determine function
Time Frame
2 years
Title
Clinically-Assessed Foot and Ankle Function
Description
American Orthopedic Foot and Ankle Score (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale
Time Frame
2 years
Title
Health Status
Description
12-item short form health survey, use of concomitant medications, and changes in health status
Time Frame
2 years
Title
Surgical Complications
Description
Fractures, nerve injuries, blood loss, infection, etc.
Time Frame
2 years
Title
Implant Failure
Description
Failure of the Cartiva Synthetic Cartilage Implant
Time Frame
2 years
Title
Secondary Surgical Intervention
Description
Additional subsequent procedures, including removal, reoperation, revision, or supplemental fixation
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18 and 80 years old
Grade 2 or 3 hallux rigidus based on Coughlin and Shurnas classification
Presence of good bone stock as determined on pre-operative x-rays not requiring bone grafting
Capable of consenting for self
Exclusion Criteria:
Patients <18 years of age
Grade 1 or 4 hallux rigidus based on Coughlin and Shurnas classification
Active bacterial infection of the foot
Previous bilateral total knee arthroplasty
Previous fracture or significant trauma to the ipsilateral knee
Inflammatory anthropathy
Gout
Inadequate bone stock
Previous anthrodesis or arthroplasty performed on the ipsilateral first MTP
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amgad Amin, MD
Organizational Affiliation
Department of Orthopedic Surgery and Rehabilitation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Synthetic Cartilage Implant vs Osteochondral Autograft Transfer for Advanced 1st Metatarsal Phalangeal Joint Arthritis
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