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Medial Malleolus: Operative Or Non-operative (MOON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362229
Recruitment Status : Active, not recruiting
First Posted : December 5, 2017
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Tom Carter, Royal Infirmary of Edinburgh

Brief Summary:

Medial malleolus: Operative Or Non-operative (MOON study) Ankle fractures are a common Orthopaedic trauma presentation, accounting for approximately 10% of the workload. There has been debate regarding the significance of the contribution of the medial malleolus to ankle stability. Some deem the lateral malleolus as the key stabiliser. With this anatomically aligned the ankle joint should be stable. Operating on the medial malleolus fracture often requires a second generous skin incision, soft tissue stripping and insertion of metalwork. This carries with it the risk of wound complications, infection and increased operation time. High risk patients including the elderly, diabetics and those with significant swelling following injury are particularly vulnerable. The study will include adult patients (≥16 years) with capacity to consent and complete post-operative questionnaires, presenting to a single Orthopaedic trauma unit. Participants will be randomised to fixation or non-fixation of associated medial malleolus fractures at the same time as fixation of the lateral malleolar fracture to assess if this impacts on validated patient outcomes, failure, operative time and complications over a one-year follow-up. Only one trial has been published, showing no significant difference between failure rates or outcomes, but reduced operative time.

Participants will be enrolled into the trial following informed consent. The final decision on whether a participant is eligible can only be made during surgery when the medial malleolus fracture has reduced with no more than 2mm displacement. If this is confirmed the participant will be randomised to receive either fixation or non-fixation of the medial malleolus. Randomisation therefore occurs at the time of surgery. Participants will be reviewed at set post-operative checkpoints, with X-rays and patient reported outcome scores. Trial data will hopefully enable surgeons to make better informed decisions when managing patients with ankle fracture dislocations.


Condition or disease Intervention/treatment Phase
Ankle Fracture - Medial Malleolus Procedure: Fixation Procedure: Non-fixation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial with 50:50 randomisation into one of 2 groups. Randomisation will also be stratified be age of patient (>= 65 and <65 years).
Masking: None (Open Label)
Masking Description: There is no blinding possible in this trial as the presence or absence of medial sided surgery is obvious to both the surgeon and the patient due to the presence or absence of a skin incision.
Primary Purpose: Treatment
Official Title: Medial Malleolus: Operative or Non-operative - A Prospective Randomized Controlled Trial of Operative Versus Non-operative Management of Associated Medial Malleolus Fractures in Unstable Fracture Dislocations of the Ankle Joint'
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FIXATION
Medial malleolus fixation, with the method of fixation left to the surgeons discretion.
Procedure: Fixation
A well reduced medial malleolus fracture will undergo internal fixation, guided by the surgeon's skill and expertise

Active Comparator: NON-FIXATION
A well reduced medial malleolus fracture is then left without fixation ie, non-operative management.
Procedure: Non-fixation
A well reduced medial malleolus fracture will be left without fixation




Primary Outcome Measures :
  1. Change in Olerud & Molander Ankle Score (OMAS) over a one-year post-operative period [ Time Frame: 6 week, 3 months, 6 months and one year. ]
    The OMAS is a functional rating scale developed in 1984, which has been used extensively as a research tool in foot and ankle surgery. It includes nine parameters: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living. The sub-score parameters are summated to generate a final score from 0 - 100, with '100' representing an excellent functional outcome and '0' being the worse possible outcome.


Secondary Outcome Measures :
  1. Change in Euroqol-5D over a one-year post-operative period [ Time Frame: 6 week, 3 months, 6 months and one year. ]
    A standardised instrument for use as a measure of health outcome. A score of '+1.0' represents an excellent state of general health and a score of '-1.0' represents a very poor state of general health.

  2. Change in Manchester-Oxford Foot Questionnaire (MOXFQ) over a one-year post-operative period [ Time Frame: 6 week, 3 months, 6 months and one year. ]
    A validated and reliable PROM for surgery of the foot and ankle, it consists of 16-items from three domains: walking/standing (7 items), pain (5 items) and social interaction (4 items). Each item is scored on a 5-point Likert scale ranging from no limitation to maximum limitation (0,1,2,3,4). The sub-scales are summated to generate a raw score out of 64 is then converted to a 0 - 100 metric score, with '100' being awarded for the most severe limitation and a score of '0' for no limitation whatsoever.

  3. Tourniquet time [ Time Frame: Immediately post-operatively ]
    Length of time tourniquet inflated for during surgery

  4. Change in Visual analogue pain scale (VAS) over a one-year post-operative period [ Time Frame: 6 week, 3 months, 6 months and one year. ]
    Assessment of pain with '100' being no pain and '0' being extreme pain.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We hypothesise we will recruit slightly more females than males as this is our experience in our local unit with routine practice.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥16 years
  2. Able to consent to treatment
  3. Unstable fracture dislocation of the ankle joint requiring operative intervention as defined in section 3.1
  4. Closed injury
  5. Weber B & Weber C fractures
  6. Surgery date within two weeks of date of fracture

Exclusion Criteria:

  1. Patients unable to comply with post-operative data gathering including completing questionnaires in English language
  2. Additional lower limb injury, which may impact on patient rehabilitation
  3. Open fracture
  4. Confirmed severe associated neurovascular injuries
  5. Distal tibial intra-articular fractures/ pilon type injuries
  6. Supination-adduction type 2 (SAD-2) fracture configurations with a medial malleolus vertical shear fracture
  7. Patients medically unfit for surgery
  8. Patients declining operative management
  9. Non-residents, unable to return to the unit for follow-up for a period of 1-year
  10. Current engagement in a pharmaceutical/drug trial
  11. Where the treating surgeon does not feel that inclusion in the trial is in the patients' best interest either due to the fracture pattern or patient factors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362229


Locations
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United Kingdom
Edinburgh Orthopaedic Trauma Unit, Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
Royal Infirmary of Edinburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tom Carter, Principle Investigagor, Royal Infirmary of Edinburgh
ClinicalTrials.gov Identifier: NCT03362229    
Other Study ID Numbers: 2017/0262
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries