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

Deep Deltoid Ligament Integrity in Ankles With Isolated Weber Type B Fractures - Mini-invasive Arthroscopic Evaluation Using the Arthrex NanoScope.

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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Fractures; Ankle Fracture - Lateral Malleolus; Deltoid Ligament; Sprain (Strain) (Ankle)
• Intervention / Treatment: Device: Nonoperative treatment; Behavioral: Standardized education; Procedure: Operative treatment

Detailed Description

Purpose and research question The main purpose is to evaluate integrity in the deep deltoid ligament in ankles with isolated Weber type B fractures using a minimally invasive Nanoscopic technique. Further results of a Nanoscopic evaluation will be correlated to the results of gravity stress and weightbearing radiographs. Additionally, the Nanoscopic evaluation will be used to assess associated injuries including cartilage and syndesmotic lesions.

Methods Primary evaluation will be done in the acute setting. All isolated Weber type B fractures without radiological signs of instability (medial clear space of 7 mm or less) on initial non-weightbearing radiographs presenting to our clinic will be evaluated for inclusion. Nanoscopic evaluation will determine stability for all patients with radiographic measurements indicating "uncertain stability". "Uncertain stability" of the ankle is assumed when at least one out of 3 (plain-, gravity- or weightbearing-) radiographs is showing instability. Like Seidel et al. (2017), in the event of a MCS of over 7 mm on initial non-weightbearing radiographs the ankle is considered unstable and will be evaluated for surgery. These patients will not be evaluated for inclusion.

For radiographic tests the size of the MCS will make up an indirect measurement of deltoid ligament capacity. The MCS is defined as the distance between the medial border of the talus and the lateral border of the medial malleolus on a line parallel to and 5 mm below the talar dome on anteroposterior radiographs. A MCS of 5 mm or less defines the ankle as stable. An MCS >5 mm AND 1 mm or more increase compared to the contralateral (non-injured ankle) ankle defines the ankle as unstable.

Plain-, weightbearing- and gravity stress radiographs and nanoscopic evaluation will be done 3-14 days after injury at the outpatient clinic. The radiographic test battery will be done prior to nanoscopy. Only patients demonstrating at least one positive stress radiograph (weightbearing or gravity) or a plain radiograph with a MCS measurement above the threshold (5 mm AND 1 mm or more increase compared to the contralateral ankle) will undergo nanoscopic evaluation.

Participants with "uncertain" stability will be assigned to non-operative or surgical treatment based on ankle stability evaluation using results from the NanoScopic evaluation consistently. Stability is assumed when the posterior part of the deep deltoid ligament is visible and intact. Stable ankles will be treated non-operatively with 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. Unstable ankles will be operated on. Standard operative treatment is open reduction and internal fixation 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marius Molund, MD, PhD; Phone Number: +4790093988; Email: mariusmolund@hotmail.com
• Study Contact Backup: Name: Martin G Gregersen, PT, Msc; Phone Number: +4748171718; Email: martinggregersen@gmail.com

Study Locations

• Norway
  • Østfold
    • Sarpsborg, Østfold, Norway, 1719
      • Recruiting
      • Østfold HT
      • Contact: Marius Molund, MD, PhD; Phone Number: +4790093988; Email: mariusmolund@hotmail.com
      • Contact: Martin G Gregersen, PT, Msc; Phone Number: +4748171718; Email: martinggregersen@gmail.com
      • Principal Investigator: Marius Molund, MD, PhD
      • Sub-Investigator: Martin G Gregersen, PT, Msc
      • Sub-Investigator: Fredrik A Nilsen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients:

• With isolated Weber type B fractures without radiological signs of medial clear space widening on initial plain radiographs (MCS < 7mm).
• Demonstrating at least one positive stress radiograph (weightbearing or gravity) or a plain radiograph with a MCS measurement above the threshold (5 mm AND 1 mm or more increase compared to the contralateral ankle) (WP2).
• 18-80 years of age.
• With pre-injury walking ability without aids.

Exclusion Criteria:

Patients:

• With fracture of the medial malleolus, pre-hospital closed fracture reduction, open fracture, fracture resulting from high-energy trauma or multi-trauma and pathologic fracture.
• With poorly regulated Diabetes Mellitus type 1 and 2, neuropathies and generalized joint disease such as Rheumatoid Arthritis.
• That are assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
• With previous history of ipsilateral ankle fracture.
• With previous history of ipsilateral major ankle-/foot surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nonoperative treatment if deltoid ligament is intact; AirCast Air-stirrup (DJO Global) functional orthosis for 6 weeks.	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.; Other Names: Conservative Treatment; 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.
Experimental: Operative treatment if deltoid ligament is ruptured; Open reduction, internal fixation of the fibular fracture using plate and screws.	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.; 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.; Other Names: Open reduction, internal fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Manchester-Oxford Foot Questionnaire (MOXFQ)	The MOXFQ (Dawson et al., 2006) was developed to measure perceived foot- specific functioning and health-related quality of life. The MOXFQ is supported as the current most valid, reliable and responsive ankle-specific instrument (Jia, Huang, & Gagnier, 2017) and has been validated for use in ankle pathology (Dawson et al., 2011). It is available in Norwegian, but it has not been validated in its translated form. The score comprises a total of 16 items. They are distributed within 3 dimensions; foot pain (5 items), walking/standing (7 items) and social interaction (4 items) where all items are scored on a 5-point Likert scale, scored 0 (best) to 4 (worst). The MOXFQ index (Morley et al., 2013) will be used, where scores are converted to a metric (0-100) scale. Lower scores indicate less pain and higher levels of ankle/foot functioning (Morley et al., 2013).	6 weeks, 12 weeks, 52 weeks, 104 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Registration of adverse events	Adverse events including malalignment, deep vein trobosis, nerve injury, wound infection, delayed wound healing and crossover to surgery (including reason for crossover).	104 weeks.
Registration of fracture union	Fracture union will be registered as union/nonunion and defined as concurrent radiographic evidence of fracture union and pain-free palpation over the fracture location.	12 weeks.
Registration of the incidence of concomitant cartilage injuries.	Evaluated peroperatively by minimally invasive arthroscopy.	Baseline.

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Investigators: Principal Investigator: Marius Molund, Md, PhD, Ostfold HT

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Anticipated): September 15, 2024
• Study Completion (Anticipated): September 15, 2024

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Weber B; Rotational ankle fracture; Ankle stability; Deep deltoid ligament; Deltoid ligament injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Sprains and Strains; Ankle Fractures
• Other Study ID Numbers: 123245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No