Plantar Plate TearNCT04949685
Evaluation of Clinical and Functional Results After Operative Correction of Lesser Toe Deformities
An observational study of Plantar Plate Tear and Metatarsalgia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The plantar plate is an important static stabilizer of lesser metatarsophalangeal joints, and disruptions of the plantar plate can lead to significant instability and lesser toe deformities.Our study proposes an inexpensive and versatile method for plantar plate repair Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Plantar Plate Tear, Metatarsalgia, Lesser Metatarsophalangeal Joint Instability
- What is being tested?
- plantar plate repair
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Nov 2019to 24 Nov 2021
- Phase
- Observational
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent operations for lesser metatarsophalangeal joint instability between September 2015 and December 2019.
Who may be able to join
- Clinical diagnosis of lesser metatarsophalangeal joint instability
- Clinical diagnosis of metatarsalgia
- Lesser metatarsophalangeal joint instability clinical grades of II to III, which were determined using the drawer test.
Who cannot join
- Previous operatve treatment of the affected lesser metatarsophalangeal joint.
- Rheumatioid arthritis.
- Neurologic disorders (e.g., parkinsonism, Charcot's neuroarthropathy…etc.).
- Postoperative follow-ups of less than 12 months
Trial locations and contacts
1 site in 1 country.
About this study
The plantar plate is an important static stabilizer of lesser metatarsophalangeal joints, and disruptions of the plantar plate can lead to significant instability and lesser toe deformities.Our study proposes an inexpensive and versatile method for plantar plate repair
Read the detailed description
A torn plantar plate is small and difficult to access using regular instruments in a restricted operative field. A unique method for plantar plate repairs was used to repair various configurations of plantar plate tears with standard operative instruments that is available in most operating rooms. A retrospective study was performed on patients who underwent operations for lesser MTPJ instability between September 2015 and December 2019. The outcome analysis included the Lesser Metatarsophalangeal-Interphalangeal Scale from the American Orthopedic Foot and Ankle Society (AOFAS) forefoot score, the Visual Analogue Scale score for pain and satisfaction, and answering the question "Would you recommend this procedure to other patients?"
- Conditions
- Plantar Plate Tear, Metatarsalgia, Lesser Metatarsophalangeal Joint Instability, Hammer Toe, Surgery, Plantar Plate Repair
- Being tested
- plantar plate repair
- Medical subject headings
- Metatarsalgia, Hammer Toe Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plantar plate repairProcedure or surgery
surgical repair via dorsal approach of lesser metatarsophalangeal joint general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| symptomatic plantar plate rupture | plantar plate repair operation for symptomatic lesser metatarsophalangeal joint instability Receives: Procedure: plantar plate repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesser Metatarsophalangeal-Interphalangeal Scale from the Americans Orthopedic Foot and Ankle Society (AOFAS) forefoot score (0-100 points)
One of the most widely used PRO measures for foot and ankle conditions is the American Orthopedic Foot and Ankle Society Score (AOFAS).
Developed in 1994, the clinician-based AOFAS covers four different regions of the foot: The ankle-hindfoot, midfoot, metatarsophalangeal (MTP)-interphalangeal (IP) for the hallux, and MTP-IP for the lesser toes.
These four anatomic regions have their own version of the AOFAS survey. Each c is designed to be used independent of the others. However, each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points.
Measured: post-operative >12 months
Visual Analogue Scale score (VAS) for pain (0-10 points)
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
In this study, pre-operative VAS score and post-operative score for pain were obtained for evaluating the clinical outcome. "0" means no pain; "10" means very painful.
Measured: pre-opreative and post-operative >12 months
Visual Analogue Scale score for satisfaction (0-10 points)
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
In this study, pre-operative VAS score and post-operative score for satisfaction were obtained for evaluating the clinical outcome. "0" means unsatisfied ; "10" means very satisfied.
Measured: post-operative >12 months
Secondary outcomes (3)
hallux valgus angle (degree)
Hallux valgus angle is the angle between the axis of the 1st metatarsal and the axis of the proximal phalanx of the 1st toe. It can only be measured on a radiograph performed whilst weight bearing.
In this study, pre-operative and post-operative hallux valgus angle were obtained for evaluating the operative outcome.
Measured: pre-opreative and post-operative >12 months
1-2 intermetatarsal angle (degree)
1-2 intermetatarsal angle is the angle between the axis of the 1st metatarsal and the axis of the 2nd metatarsal. It can only be measured on a radiograph performed whilst weight bearing.
In this study, pre-operative and post-operative hallux valgus angle were obtained for evaluating the operative outcome.
Measured: pre-opreative and post-operative >12 months
Metatarsophalangeal joint angle( for lesser toes, degree)
Metatarsophalangeal joint angle is the angle between the axis of the metatarsal and the axis of the proximal phalanx of the lesser toe. It can only be measured on a radiograph performed whilst weight bearing. positive angle indicates a lateral inclination, and negative angle denotes a varus inclination.
In this study, pre-operative and post-operative hallux valgus angle were obtained for evaluating the operative outcome.
Measured: pre-opreative and post-operative >12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start25 Nov 2019
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Plantar Plate TearStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949685
- Sponsor's protocol ID
- 201909030RIND
- Status last verified
- Oct 2020
- First submitted
- 21 Jun 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coughlin MJ. Crossover second toe deformity. Foot Ankle. 1987 Aug;8(1):29-39. doi: 10.1177/107110078700800108.
PubMed 3623359Weil L Jr, Sung W, Weil LS Sr, Malinoski K. Anatomic plantar plate repair using the Weil metatarsal osteotomy approach. Foot Ankle Spec. 2011 Jun;4(3):145-50. doi: 10.1177/1938640010397342. Epub 2011 Mar 18.
PubMed 21421939Chang SM, Huang PJ, Farn CJ, Lin SY, Wang CC, Wang CL, Chen PY. A versatile method for dorsal-approach plantar plate repair using standard operative instruments. BMC Musculoskelet Disord. 2022 Jan 3;23(1):11. doi: 10.1186/s12891-021-04951-w.
PubMed 34980055
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Functional Results After Operative Correction of Lesser Toe Deformities
- ClinicalTrials.gov ID
- NCT04949685
- Acronym / sponsor ID
- 201909030RIND
- Conditions
- Plantar Plate Tear, Metatarsalgia, Lesser Metatarsophalangeal Joint Instability, Hammer Toe, Surgery, Plantar Plate Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 2 Jul 2021 (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.
The plantar plate is an important static stabilizer of lesser metatarsophalangeal joints, and disruptions of the plantar plate can lead to significant instability and lesser toe deformities.Our study proposes an inexpensive and versatile method for plantar plate repair
Detailed description
A torn plantar plate is small and difficult to access using regular instruments in a restricted operative field. A unique method for plantar plate repairs was used to repair various configurations of plantar plate tears with standard operative instruments that is available in most operating rooms. A retrospective study was performed on patients who underwent operations for lesser MTPJ instability between September 2015 and December 2019. The outcome analysis included the Lesser Metatarsophalangeal-Interphalangeal Scale from the American Orthopedic Foot and Ankle Society (AOFAS) forefoot score, the Visual Analogue Scale score for pain and satisfaction, and answering the question "Would you recommend this procedure to other patients?"
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic plantar plate rupture | – | Procedure: plantar plate repairplantar plate repair operation for symptomatic lesser metatarsophalangeal joint instability |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent operations for lesser metatarsophalangeal joint instability between September 2015 and December 2019.
Key inclusion criteria (3 listed)
- Clinical diagnosis of lesser metatarsophalangeal joint instability
- Clinical diagnosis of metatarsalgia
- Lesser metatarsophalangeal joint instability clinical grades of II to III, which were determined using the drawer test.
Key exclusion criteria (4 listed)
- Previous operatve treatment of the affected lesser metatarsophalangeal joint.
- Rheumatioid arthritis.
- Neurologic disorders (e.g., parkinsonism, Charcot's neuroarthropathy…etc.).
- Postoperative follow-ups of less than 12 months
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 |
|---|---|---|
| plantar plate repairsurgical repair via dorsal approach of lesser metatarsophalangeal joint general anesthesia | Procedure or surgery | symptomatic plantar plate rupture |
Primary outcome
Lesser Metatarsophalangeal-Interphalangeal Scale from the Americans Orthopedic Foot and Ankle Society (AOFAS) forefoot score (0-100 points)
Time frame: post-operative >12 months
One of the most widely used PRO measures for foot and ankle conditions is the American Orthopedic Foot and Ankle Society Score (AOFAS). Developed in 1994, the clinician-based AOFAS covers four different regions of the foot: The ankle-hindfoot, midfoot, metatarsophalangeal (MTP)-interphalangeal (IP) for the hallux, and MTP-IP for the lesser toes. These four anatomic regions have their own version of the AOFAS survey. Each c is designed to be used independent of the others. However, each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points.
Visual Analogue Scale score (VAS) for pain (0-10 points)
Time frame: pre-opreative and post-operative >12 months
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this study, pre-operative VAS score and post-operative score for pain were obtained for evaluating the clinical outcome. "0" means no pain; "10" means very painful.
Visual Analogue Scale score for satisfaction (0-10 points)
Time frame: post-operative >12 months
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this study, pre-operative VAS score and post-operative score for satisfaction were obtained for evaluating the clinical outcome. "0" means unsatisfied ; "10" means very satisfied.
3 secondary outcomes
hallux valgus angle (degree)
Time frame: pre-opreative and post-operative >12 months
1-2 intermetatarsal angle (degree)
Time frame: pre-opreative and post-operative >12 months
Metatarsophalangeal joint angle( for lesser toes, degree)
Time frame: pre-opreative and post-operative >12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Results publication: PubMed 3623359Coughlin MJ. Crossover second toe deformity. Foot Ankle. 1987 Aug;8(1):29-39. doi: 10.1177/107110078700800108.
- Results publication: PubMed 21421939Weil L Jr, Sung W, Weil LS Sr, Malinoski K. Anatomic plantar plate repair using the Weil metatarsal osteotomy approach. Foot Ankle Spec. 2011 Jun;4(3):145-50. doi: 10.1177/1938640010397342. Epub 2011 Mar 18.
- Derived from this study: PubMed 34980055Chang SM, Huang PJ, Farn CJ, Lin SY, Wang CC, Wang CL, Chen PY. A versatile method for dorsal-approach plantar plate repair using standard operative instruments. BMC Musculoskelet Disord. 2022 Jan 3;23(1):11. doi: 10.1186/s12891-021-04951-w.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plantar Plate Tear and Metatarsalgia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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 22 Dec 2021. 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lesser Metatarsophalangeal-Interphalangeal Scale from the Americans Orthopedic Foot and Ankle Society (AOFAS) forefoot score (0-100 points) (time frame: post-operative >12 months). The study lists 3 primary outcomes in all. 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 NCT04949685, which also lists 3 linked publications.
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 22 Dec 2021.