CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
AMPLEX +1 moredevice
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Indicated for ankle or hindfoot arthrodesis (tibiotalar, talocalcaneal, talonavicular, calcaneocuboid, double hindfoot, or triple hindfoot)
  • ✓Pain on weight-bearing ≥40 mm on 100 mm VAS at the arthrodesis site
  • ✓At least one comorbid risk factor warranting supplemental graft (bone defect, multiple joints, large surface area, deformity, post-traumatic arthritis, osteoporosis, or subchondral cyst)
  • ✓Joint space(s) can be adequately filled: single joint up to 5 cm³, double/triple fusion up to 10 cm³ total, ankle up to 10 cm³
Key exclusion· 20
  • ✕Bone deficit requiring a structural graft
  • ✕Charcot foot disease
  • ✕Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joint(s)
  • ✕Requires osteotomy or fusion of the midfoot joints

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03028415
NCT03028415N/ACompleted
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A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle

Ferring Pharmaceuticals·interventional·Posted Jan 23, 2017·Updated Mar 11, 2021

In Brief

A clinical study evaluating AMPLEX and Autogenous Bone Graft (ABG) for Arthrodesis Surgery Involving the Hindfoot or Ankle. Completed, enrolled 56 participants across 36 sites in 2 countries.

Detailed Summary

To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthrodesis Surgery Involving the Hindfoot or Ankle
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 23, 2017
Enrollment StartJul 28, 2017
Primary CompletionJan 9, 2020
Study CompletionJul 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.4 years ago

Interventions

AMPLEXdevice

A bone graft substitute

Autogenous Bone Graft (ABG)procedure

Control material administered by surgical implant