Metatarsophalangeal Joint ArthritisNCT03489876
Synthetic Cartilage Implant vs Osteochondral Autograft Transfer for Advanced 1st Metatarsal Phalangeal Joint Arthritis
A study testing Synthetic Cartilage Implant and Osteochondral Autograft Transfer in people with Metatarsophalangeal Joint Arthritis, run by University of Oklahoma.
Trial summary
This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metatarsophalangeal Joint Arthritis
- What is being tested?
- Synthetic Cartilage Implant and Osteochondral Autograft Transfer
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Gout
- Inadequate bone stock
- Previous anthrodesis or arthroplasty performed on the ipsilateral first MTP
About this study
Official title: Comparison of Synthetic Cartilage Implant Versus Osteochondral Autologous Transfer for Advanced Hallux Rigidus, A Prospective Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Metatarsophalangeal Joint Arthritis
- Being tested
- Synthetic Cartilage Implant, Osteochondral Autograft Transfer
- Keywords
- Metatarsophalangeal Joint, Arthritis, Synthetic Cartilage Implant, Cartiva, Osteochondral Autograft Transfer
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic Cartilage ImplantDevice
Also called Cartiva
The Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations.
Osteochondral Autograft TransferProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Synthetic Cartilage Implant | Experimental | Participants receive the synthetic cartilage implant. The synthetic cartilage implant that will be used is the Cartiva implant. Receives: Device: Synthetic Cartilage Implant |
| Osteochondral Autograft Transfer | Active comparator | Participants receive the current standard osteochondral autograft transfer procedure. Receives: Procedure: Osteochondral Autograft Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Pre-operative and post-operative clinical range of motion of the first MTP joint
Measured: 2 years
Patient's Pain Level
Pre-operative and post-operative visual analog pain scale
Measured: 2 years
Secondary outcomes (6)
Patient's Quality of Life
Foot and Ankle Ability Measure (FAAM) sports score uses patient-report to determine function
Measured: 2 years
Clinically-Assessed Foot and Ankle Function
American Orthopedic Foot and Ankle Score (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale
Measured: 2 years
Health Status
12-item short form health survey, use of concomitant medications, and changes in health status
Measured: 2 years
Surgical Complications
Fractures, nerve injuries, blood loss, infection, etc.
Measured: 2 years
Implant Failure
Failure of the Cartiva Synthetic Cartilage Implant
Measured: 2 years
Secondary Surgical Intervention
Additional subsequent procedures, including removal, reoperation, revision, or supplemental fixation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Jan 2019 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Lack of patient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metatarsophalangeal Joint ArthritisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amgad Amin, MD, Principal investigator, Department of Orthopedic Surgery and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489876
- Sponsor's protocol ID
- SynCartImp_Amin
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2018
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Synthetic Cartilage Implant Versus Osteochondral Autologous Transfer for Advanced Hallux Rigidus, A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03489876
- Acronym / sponsor ID
- SynCartImp_Amin
- Conditions
- Metatarsophalangeal Joint Arthritis
- Keywords
- Metatarsophalangeal Joint, Arthritis, Synthetic Cartilage Implant, Cartiva, Osteochondral Autograft Transfer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patient enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Synthetic Cartilage Implant | Experimental | Device: Synthetic Cartilage ImplantParticipants receive the synthetic cartilage implant. The synthetic cartilage implant that will be used is the Cartiva implant. |
| Osteochondral Autograft Transfer | Active comparator | Procedure: Osteochondral Autograft TransferParticipants receive the current standard osteochondral autograft transfer procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthetic Cartilage ImplantAlso: CartivaThe Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations. | Device | Synthetic Cartilage Implant |
| Osteochondral Autograft TransferThe 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. | Procedure or surgery | Osteochondral Autograft Transfer |
Primary outcome
Range of Motion
Time frame: 2 years
Pre-operative and post-operative clinical range of motion of the first MTP joint
Patient's Pain Level
Time frame: 2 years
Pre-operative and post-operative visual analog pain scale
6 secondary outcomes
Patient's Quality of Life
Time frame: 2 years
Clinically-Assessed Foot and Ankle Function
Time frame: 2 years
Health Status
Time frame: 2 years
Surgical Complications
Time frame: 2 years
Implant Failure
Time frame: 2 years
Secondary Surgical Intervention
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amgad Amin, MD principal investigator
Department of Orthopedic Surgery and Rehabilitation
Questions about this trial
What is this clinical trial studying?
A study testing Synthetic Cartilage Implant and Osteochondral Autograft Transfer in people with Metatarsophalangeal Joint Arthritis, run by University of Oklahoma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.