Post Operative Ankle Splint Study - Prospective Multi Center Randomized Controlled Trial

NCT04796168 | Completed

• 1 other identifier: 1240/2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Ankle fractures are some of the most common orthopedic presentations, however, controversy in their management and their post-operative rehabilitation protocols exist. Most displaced ankle fractures treated with anatomical reduction and stable internal fixation to allow early range of motion by allowing rigid fixation and restoration of ankle joint congruence. Post-operative rehabilitation protocols varies between surgeons and institutions with the majority emphasising early rehabilitation protocols. The use of a splint. The rational for splinting ankle fractures after rigid fixation is to decrease pain level, rest the soft tissues and prevent equinus deformity. Up to date there is no scientific research to question the benefit of routine use of splints after rigid fixation of ankle fractures. Methods: A prospective multi-centre randomised control trial. Approximately fifty patients will be enrolled from 3 hospitals (Adan, Mubarak and Farwaniya hospital) over a 1 year period. The studied sample will be randomised into 2 groups using computerised randomisation software: splint group and no-splint group. The patients will be examined at set intervals for pain, swelling, deep-vein thrombosis and a set of scoring tools. The tools include: visual analogue score (VAS) for pain, Short Form Health Survey (SF-36), American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score, physical and radiological assessment at 2 weeks, 3 months, 6 months and 1 year intervals. Statistical Package for the Social Sciences program (SPSS) will be used for statistical analysis Results/outcomes: Functional scores, symptoms and signs, complications, radio-graphic and clinical follow up will be recorded.

Conditions

Ankle Fractures; Splints

Outcome Measures

Primary Outcomes (2)

• Assessing the change in the level of pain between the splint and no-splint groups

  Visual analogue scale (0;lowest pain, 10;highest pain)

  Change in pain from 2 weeks postop to 1 year postop

• Assessing the change in ankle swelling from 2 weeks postop to 1 year postop in the splint and no-splint groups

  Measuring tape to assess supramalleolar, mid-foot, and mid-calf circumference

  Change in swelling from 2 weeks postop to 1 year postop

Secondary Outcomes (2)

• Change in the functional scoring system used below

  Change in American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scorefrom 2 weeks postop to 1 year postop

• Number of participants with; infection, nonunion, deep-vein thrombosis, stiffness, equinus

  From 2 weeks postop - 1 year postop

Study Arms (2)

post operative Ankle fractures with splint

ACTIVE COMPARATOR

All patient who meet the inclusion criteria of having ankle fracture that rigidly fixed and randomized to receive splint post operative

Procedure: Splinting (plaster of paris)

post operative Ankle fractures without splint

NO INTERVENTION

All patient who meet the inclusion criteria of having ankle fracture that rigidly fixed and randomized to receive NO splint post operative

Interventions

Splinting (plaster of paris) PROCEDURE

Placing stockinette followed by cotton rolls and 10-12 layer of posterior ankle splint made of plaster of paris

post operative Ankle fractures with splint

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A.O 44 ankle fractures requiring surgical fixation (uni or bimalleolar with /without syndesmotic injury)

You may not qualify if:

• pathological fracture
• poly trauma pilon fractures open fractures other associated fractures in same extremity peripheral neuropathy

Sponsors & Collaborators

• Kuwait Institute for Medical Specialization: lead
• Kuwait University: collaborator

Study Sites (1)

Mubarak Al kabeer hospital

Kuwait City, Kuwait

Location

Related Publications (7)

• Michelson JD. Fractures about the ankle. J Bone Joint Surg Am. 1995 Jan;77(1):142-52. doi: 10.2106/00004623-199501000-00020. No abstract available.

  PMID: 7822349 BACKGROUND

• Ahl T, Dalen N, Selvik G. Mobilization after operation of ankle fractures. Good results of early motion and weight bearing. Acta Orthop Scand. 1988 Jun;59(3):302-6. doi: 10.3109/17453678809149368.

  PMID: 3132812 BACKGROUND

• Daly PJ, Fitzgerald RH Jr, Melton LJ, Ilstrup DM. Epidemiology of ankle fractures in Rochester, Minnesota. Acta Orthop Scand. 1987 Oct;58(5):539-44. doi: 10.3109/17453678709146395.

  PMID: 3425285 BACKGROUND

• Valtola A, Honkanen R, Kroger H, Tuppurainen M, Saarikoski S, Alhava E. Lifestyle and other factors predict ankle fractures in perimenopausal women: a population-based prospective cohort study. Bone. 2002 Jan;30(1):238-42. doi: 10.1016/s8756-3282(01)00649-4.

  PMID: 11792591 BACKGROUND

• Honkanen R, Tuppurainen M, Kroger H, Alhava E, Saarikoski S. Relationships between risk factors and fractures differ by type of fracture: a population-based study of 12,192 perimenopausal women. Osteoporos Int. 1998;8(1):25-31. doi: 10.1007/s001980050044.

  PMID: 9692074 BACKGROUND

• Smeeing DP, Houwert RM, Briet JP, Kelder JC, Segers MJ, Verleisdonk EJ, Leenen LP, Hietbrink F. Weight-bearing and mobilization in the postoperative care of ankle fractures: a systematic review and meta-analysis of randomized controlled trials and cohort studies. PLoS One. 2015 Feb 19;10(2):e0118320. doi: 10.1371/journal.pone.0118320. eCollection 2015.

  PMID: 25695796 BACKGROUND

• Lin CW, Donkers NA, Refshauge KM, Beckenkamp PR, Khera K, Moseley AM. Rehabilitation for ankle fractures in adults. Cochrane Database Syst Rev. 2012 Nov 14;11:CD005595. doi: 10.1002/14651858.CD005595.pub3.

  PMID: 23152232 RESULT

MeSH Terms

Conditions

Ankle Fractures

Interventions

Calcium Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Minerals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ali Jarragh, MD

  Kuwait University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 12, 2021
• Study Start: February 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)