A trial comparing weight bearing to non-weight bearing following ankle fracture fixation

A randomised controlled trial to compare the functional outcomes of two weight bearing protocols following open reduction and internal fixation of ankle fractures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33416471

Enrollment

Registered

2010-10-27

Start date

2011-01-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closed ankle fractures Injury, Occupational Diseases, Poisoning Ankle fractures

Interventions

Both the delayed and early weight bearing groups will have a backslab applied at the time of surgery. At 2 weeks this will be converted to a full non weight bearing cast in the delayed weight bearing

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with ankle fractures admitted for an open reduction internal fixation (ORIF) by the Trauma and Orthopaedic Department at St George's Hospital and St Thomas' Hospital 2. Radiological evidence of a fracture of the ankle requiring fixation which occurs alone (AO classification: 44-A1.2, 44-A1.3, 44-A2.1, 44-A2.2, 44-A2.3, 44.A3.1, 44-A3.2, 44-A3.3, 44-B1.1, 44-B1.2, 44-B1.3, 44.B2.1, 44-B2.2, 44-B2.3, 44-B3.1, 44-B3.2, 44-B3.3, 44-C1.1, 44-C1.2, 44-C1.3, 44.C2.1, 44-C2.2, 44-C2.3, 44-C3.1, 44-C3.2, 44-C3.3 ; Arbeitsgemeinschaft für Osteosynthesefragen/Orthopedic Trauma Association [AO/ATO] Classification, 2007) 3. Female and male subjects greater than or equal to 18 to 70 years 4. Body mass index (BMI) 16 - 33 kg/m^2 (minimum body weight 50 kg, maximum 140 kg) 5. Glasgow coma score (GCS) 15 6. Signed Informed Consent Form. The patient has to be able to give consent personally

Exclusion criteria

Exclusion criteria: 1. Inability to undertake assessment and treatment procedures 2. Contralateral lower limb injury 3. Inability to non-weight bear initially if allocated to non-weight bearing group 4. Unstable or relative stability ORIF due to surgical difficulty and fracture configuration or poor bone stock (e.g. osteoporosis) as determined by unstable valgus/varus testing on image intensifier in theatre and post-operative notes 5. Rupture to the syndesmosis 6. Previous ankle fracture 7. Anderson and Gustilo Grade II and III open fractures 8. Fixation requiring bone grafting 9. Active or past history of malignant tumour 10. Evidence of systemic or localised infection at time of surgery 11. Evidence of immunosuppression 12. Diagnosis of diabetes mellitus (Type I or Type II) 13. Gross osteoarthitic changes of the ankle joint (Grade 3 or above) 14. Previous surgical intervention to the operated ankle 15. Inability to attend out-patient physiotherapy appointments 16. Inability to independently mobilise with or without walking aids 17. Unwillingness to participate

Design outcomes

Primary

Measure	Time frame
Olerud and Molander Subjective Ankle Score: This was chosen as the primary outcome measure since our research question asks that we assess patient's function primarily, which this outcome measure satisfies. Furthermore, previous authors have used this outcome measure in their investigations on ankle fracture management, and therefore, by using this outcome measure, we would be able to compare our findings to their results. Finally, although the reliability and validity of this tool has not been formally assessed for ankle fracture populations, the literature suggests that such a procedure has not been assessed with any outcome measure, and due to the other two factors, it was deemed that this would be the most appropriate outcome measure. Measured at 6 weeks, 3 months, 6 months, 1 year.	—

Measure

Time frame

Olerud and Molander Subjective Ankle Score: This was chosen as the primary outcome measure since our research question asks that we assess patient's function primarily, which this outcome measure satisfies. Furthermore, previous authors have used this outcome measure in their investigations on ankle fracture management, and therefore, by using this outcome measure, we would be able to compare our findings to their results. Finally, although the reliability and validity of this tool has not been formally assessed for ankle fracture populations, the literature suggests that such a procedure has not been assessed with any outcome measure, and due to the other two factors, it was deemed that this would be the most appropriate outcome measure. Measured at 6 weeks, 3 months, 6 months, 1 year.

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Secondary

Measure	Time frame
1. EQ-5D, assessed in the clinic setting. Although this measure is frequently assessed as a postal questionnaire, it will be assessed in the clinic to increase the response rate. Measured at 6 weeks, 3 months, 1 year; range of motion at 6 weeks 2. Range of ankle plantar flexion and dorsiflexion of both the injured and un-injured ankle. This will be assessed using goniometry and the bony landmarks of the head of the fifth metatarsal, and the fibula head 3. Patient reported outcome measures will also be a requirement within the UK National Health Service 4. Any post-operative complications such as infection, mal-union, implant loosening or breakage, deep vein thrombosis (DVT), measured at 6 weeks 5. Total time lost from work by asking each patient how long they required off work if applicable 6. Duration of in-patient hospital stay by reviewing the medical notes 7. Duration of physiotherapy rehabilitation by reviewing the physiotherapy notes, assessed at one year 8. Finally anatomical reduction and time to fracture union, assessed by an orthopaedic surgeon using clinical and radiographic examination. The latter assessment will be determined by satisfying the following criteria: 8.1. No bony tenderness on palpation around the fracture site 8.2. Pain-free weight bearing (determined as when the patient can stand solely on the injured leg reportedly pain-free for a total of 10 seconds) 8.3. Bridging callus on at least two cortices (orthogonal) on plain radiographs Measured at 2 weeks	—

Measure

Time frame

1. EQ-5D, assessed in the clinic setting. Although this measure is frequently assessed as a postal questionnaire, it will be assessed in the clinic to increase the response rate. Measured at 6 weeks, 3 months, 1 year; range of motion at 6 weeks 2. Range of ankle plantar flexion and dorsiflexion of both the injured and un-injured ankle. This will be assessed using goniometry and the bony landmarks of the head of the fifth metatarsal, and the fibula head 3. Patient reported outcome measures will also be a requirement within the UK National Health Service 4. Any post-operative complications such as infection, mal-union, implant loosening or breakage, deep vein thrombosis (DVT), measured at 6 weeks 5. Total time lost from work by asking each patient how long they required off work if applicable 6. Duration of in-patient hospital stay by reviewing the medical notes 7. Duration of physiotherapy rehabilitation by reviewing the physiotherapy notes, assessed at one year 8. Finally anatomical reduction and time to fracture union, assessed by an orthopaedic surgeon using clinical and radiographic examination. The latter assessment will be determined by satisfying the following criteria: 8.1. No bony tenderness on palpation around the fracture site 8.2. Pain-free weight bearing (determined as when the patient can stand solely on the injured leg reportedly pain-free for a total of 10 seconds) 8.3. Bridging callus on at least two cortices (orthogonal) on plain radiographs Measured at 2 weeks

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026