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Deep Deltoid Ligament Integrity in Weber B Ankle Fractures - Mini-invasive Arthroscopic Evaluation.

NCT04674046 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-12-17

No results posted yet for this study

Summary

Prospective cohort study to evaluate the use of a NanoScopic procedure to assess deltoid ligament injuries with outcomes measured at baseline, 6 weeks, 12 weeks, 1 year and 2 years. Further to examine whether the findings correlate with results on gravity stress test and weightbearing radiographs.

Conditions

  • Ankle Fracture - Lateral Malleolus
  • Deltoid Ligament; Sprain (Strain) (Ankle)
  • Ankle Fractures

Interventions

DEVICE

Nonoperative treatment

Patients where the ankle is evaluated as stable using arthroscopy will be treated with conservative treatment using a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.

PROCEDURE

Operative treatment

Patients where the ankle is evaluated as unstable using arthroscopy will be operated on. Standard operative treatment is open reduction and internal fixation (ORIF) of the fracture using plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.

BEHAVIORAL

Standardized education

All participants, regardless of group allocation, will receive education focusing on basic self- management. A physiotherapist will be responsible for the education. The intention will be to increase self-efficacy and encourage self-management. Participants will learn about crutch walking, cast or orthosis usage, loading principles, be advised to stay physically active within proper restrictions and how to rest and reduce pain and swelling of the ankle in the acute phase. Participants will also receive a standard information brochure about the condition, treatment and basic self-management.

Sponsors & Collaborators

  • Ostfold Hospital Trust

    lead OTHER

Principal Investigators

  • Marius Molund, Md, PhD · Ostfold HT

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2024-09-15
Completion
2024-09-15

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04674046 on ClinicalTrials.gov