Evaluation of Clinical and Functional Results After Operative Correction of Lesser Toe Deformities

NCT04949685 | Completed

• 1 other identifier: 201909030RIND
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Plantar Plate Tear; Metatarsalgia; Lesser Metatarsophalangeal Joint Instability; Hammer Toe; Surgery; Plantar Plate Repair

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  post-operative >12 months

Secondary Outcomes (3)

• hallux valgus angle (degree)

  pre-opreative and post-operative >12 months

• 1-2 intermetatarsal angle (degree)

  pre-opreative and post-operative >12 months

• Metatarsophalangeal joint angle( for lesser toes, degree)

  pre-opreative and post-operative >12 months

Study Arms (1)

symptomatic plantar plate rupture

plantar plate repair operation for symptomatic lesser metatarsophalangeal joint instability

Procedure: plantar plate repair

Interventions

plantar plate repair PROCEDURE

surgical repair via dorsal approach of lesser metatarsophalangeal joint general anesthesia

symptomatic plantar plate rupture

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent operations for lesser metatarsophalangeal joint instability between September 2015 and December 2019.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (3)

• Coughlin MJ. Crossover second toe deformity. Foot Ankle. 1987 Aug;8(1):29-39. doi: 10.1177/107110078700800108.

  PMID: 3623359 RESULT

• Weil 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.

  PMID: 21421939 RESULT

• Chang 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.

  PMID: 34980055 DERIVED

MeSH Terms

Conditions

Metatarsalgia; Hammer Toe Syndrome

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Foot Deformities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 2, 2021
• Study Start: November 25, 2019
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: December 22, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)