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Completed

NCT Number: NCT01673347

Allograft 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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptomatic of stage 3 osteoarthritis of the great toe
  • symptoms recalcitrant to nonoperative management as determined clinically by the principal investigator

Exclusion criteria

  • 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

Treatment and study plan

Meniscal Allograft

Biological

Meniscal allograft

Other names: Musculoskeletal Transplant Foundation, Meniscal transplant

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain

    Time frame: 3-months postoperative

    Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

  2. Range of Motion Plantarflexion

    Time frame: 3-months postoperative

    Range of Motion Plantarflexion

  3. Range of Motion Dorsiflexion

    Time frame: 3-months postoperative

    Range of Motion Dorsiflexion

Sponsors and collaborators

Lead sponsor

Paul Fortin, MD

Other

Collaborators

  • Musculoskeletal Transplant Foundation

Registry information

Official study title

Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe

Acronym: MTP

Important dates

Study start
2010
Primary completion
2014
Study completion
2017
First posted
Aug 28, 2012
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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