OsteoarthritisPhase 3MTPNCT01673347
Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
A Phase 3 study testing Meniscal Allograft in people with Osteoarthritis, run by Paul Fortin, MD at 1 site in United States.
Trial summary
Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Meniscal Allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 10 Mar 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic of stage 3 osteoarthritis of the great toe
- symptoms recalcitrant to nonoperative management as determined clinically by the principal investigator
Who cannot join
- diabetes mellitus
- kidney insufficiency
- oa in the adjacent joints
- malignancy with in the past 10 yrs
- minors (< 18 yrs of age)
- pregnant women and fetus
- mentally disabled or cognitively impaired individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe.
Read the detailed description
A variety of surgical procedures have been developed for the treatment of MTP joint osteoarthritis of the great toe. Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe. Patients will be evaluated for pain and range of motion at 3-months, 6-months, 1-year, 2-years, 3-years, 4-years, and 5-years postoperatively or until allograft failure. Stability of the allograft will be evaluated by the surgeon at these time points per radiographic imaging.
- Conditions
- Osteoarthritis
- Being tested
- Meniscal Allograft
- Keywords
- allograft, great toe
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniscal AllograftBiological
Also called Musculoskeletal Transplant Foundation, Meniscal transplant
Meniscal allograft
| Study group | Role | What they receive |
|---|---|---|
| MENISCAL ALLOGRAFT | Experimental | The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. Receives: Biological: Meniscal Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allograft Stability
Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.
Measured: 5-years postoperative
Secondary outcomes (3)
Pain
Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Measured: 3-months postoperative
Range of Motion Plantarflexion
Range of Motion Plantarflexion
Measured: 3-months postoperative
Range of Motion Dorsiflexion
Range of Motion Dorsiflexion
Measured: 3-months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startSep 2010
- Primary completionMay 2014
- Study completion10 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Fortin, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Musculoskeletal Transplant Foundation
- Responsible party
- Sponsor-investigator, Paul Fortin, MD, Corewell Health East
- Investigators
- PAUL FORTIN, MD, Principal investigator, WILLIAM BEAUMONT HOSPITAL ROYAL OAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673347
- Sponsor's protocol ID
- 2010-182
- Other IDs
- ISO 13485
- Acronym
- MTP
- Status last verified
- Apr 2017
- First submitted
- 14 Aug 2012
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
COLE BJ, CARTER TR, RODEO SA,
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
- ClinicalTrials.gov ID
- NCT01673347
- Acronym / sponsor ID
- MTP / 2010-182
- Conditions
- Osteoarthritis
- Keywords
- allograft, great toe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Paul Fortin, MDUniversity, hospital or other
- Collaborators
- Musculoskeletal Transplant Foundation
- Study start
- Sep 2010 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Posted 23 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe.
Detailed description
A variety of surgical procedures have been developed for the treatment of MTP joint osteoarthritis of the great toe. Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe. Patients will be evaluated for pain and range of motion at 3-months, 6-months, 1-year, 2-years, 3-years, 4-years, and 5-years postoperatively or until allograft failure. Stability of the allograft will be evaluated by the surgeon at these time points per radiographic imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MENISCAL ALLOGRAFT | Experimental | Biological: Meniscal AllograftThe meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic of stage 3 osteoarthritis of the great toe
- symptoms recalcitrant to nonoperative management as determined clinically by the principal investigator
Key exclusion criteria (7 listed)
- diabetes mellitus
- kidney insufficiency
- oa in the adjacent joints
- malignancy with in the past 10 yrs
- minors (< 18 yrs of age)
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 |
|---|---|---|
| Meniscal AllograftAlso: Musculoskeletal Transplant Foundation, Meniscal transplantMeniscal allograft | Biological | MENISCAL ALLOGRAFT |
Primary outcome
Allograft Stability
Time frame: 5-years postoperative
Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.
3 secondary outcomes
Pain
Time frame: 3-months postoperative
Range of Motion Plantarflexion
Time frame: 3-months postoperative
Range of Motion Dorsiflexion
Time frame: 3-months postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundCOLE BJ, CARTER TR, RODEO SA,
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
PAUL FORTIN, MD principal investigator
WILLIAM BEAUMONT HOSPITAL ROYAL OAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meniscal Allograft in people with Osteoarthritis, run by Paul Fortin, MD at 1 site in United States.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Allograft Stability (time frame: 5-years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01673347, which also lists 1 linked publication.
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 23 May 2017.