Medial Malleolus: Operative Or Non-operative

NCT03362229 | Completed FDA Device

• 1 other identifier: 2017/0262
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fracture - Medial Malleolus

Outcome Measures

Primary Outcomes (1)

• Change in Olerud & Molander Ankle Score (OMAS) over a one-year post-operative period

  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.

  6 week, 3 months, 6 months and one year.

Secondary Outcomes (4)

• Change in Euroqol-5D over a one-year post-operative period

  6 week, 3 months, 6 months and one year.

• Change in Manchester-Oxford Foot Questionnaire (MOXFQ) over a one-year post-operative period

  6 week, 3 months, 6 months and one year.

• Tourniquet time

  Immediately post-operatively

• Change in Visual analogue pain scale (VAS) over a one-year post-operative period

  6 week, 3 months, 6 months and one year.

Study Arms (2)

FIXATION

ACTIVE COMPARATOR

Medial malleolus fixation, with the method of fixation left to the surgeons discretion.

Procedure: Fixation

NON-FIXATION

ACTIVE COMPARATOR

A well reduced medial malleolus fracture is then left without fixation ie, non-operative management.

Procedure: Non-fixation

Interventions

Fixation PROCEDURE

A well reduced medial malleolus fracture will undergo internal fixation, guided by the surgeon's skill and expertise

FIXATION

Non-fixation PROCEDURE

A well reduced medial malleolus fracture will be left without fixation

NON-FIXATION

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: We hypothesise we will recruit slightly more females than males as this is our experience in our local unit with routine practice.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥16 years
• Able to consent to treatment
• Unstable fracture dislocation of the ankle joint requiring operative intervention as defined in section 3.1
• Closed injury
• Weber B \& Weber C fractures
• Surgery date within two weeks of date of fracture

You may not qualify if:

• Patients unable to comply with post-operative data gathering including completing questionnaires in English language
• Additional lower limb injury, which may impact on patient rehabilitation
• Open fracture
• Confirmed severe associated neurovascular injuries
• Distal tibial intra-articular fractures/ pilon type injuries
• Supination-adduction type 2 (SAD-2) fracture configurations with a medial malleolus vertical shear fracture
• Patients medically unfit for surgery
• Patients declining operative management
• Non-residents, unable to return to the unit for follow-up for a period of 1-year
• Current engagement in a pharmaceutical/drug trial

Sponsors & Collaborators

• Royal Infirmary of Edinburgh: lead

Study Sites (1)

Edinburgh Orthopaedic Trauma Unit, Edinburgh Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (2)

• Carter TH, Oliver WM, Bell KR, Graham C, Duckworth AD, White TO. Operative vs Nonoperative Management of Unstable Medial Malleolus Fractures: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2351308. doi: 10.1001/jamanetworkopen.2023.51308.

  PMID: 38236603 DERIVED

• Carter TH, Oliver WM, Graham C, Duckworth AD, White TO. Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle. Trials. 2019 Sep 12;20(1):565. doi: 10.1186/s13063-019-3642-7.

  PMID: 31514744 DERIVED

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigagor

Model Details: 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).

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: December 5, 2017
• Study Start: October 24, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Locations

GB (1)