Immediate Weight-Bearing Ankle Study

Surgery Clinical Trial

Official title:

Immediate Unprotected Weight-Bearing and Range of Motion After Open Reduction and Internal Fixation of Unstable Ankle Fractures. A Historical Control Group Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032653
• Other study ID #: FHREB #: 2016-101
• Status: Completed
• Phase: N/A
• Start date: February 9, 2017
• Est. completion date: January 18, 2021

Study information

• Verified date: April 2021
• Source: Fraser Orthopaedic Research Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single-centre historical control group comparative study will compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.

Description:

Ankle fractures are among the most common injuries, making up 9% of all fractures. Rotational ankle fractures are among the most common of all fractures, with an incidence averaging 4.2 per 1,000 individuals annually. These fractures range from minimal injuries amenable to non-surgical management to complex injuries with potential of long-term sequelae. Known risk factors for ankle fractures are age, body mass index and previous ankle fracture, with the highest incidence in elderly women.

Most ankle fractures are low-energy injuries which occur when the body rotates about a planted foot, whether it be during sports, normal gait, or otherwise. Stable ankle fractures are generally treated non-surgically, while unstable fractures are usually treated with surgical reduction and fixation, with indications previously well-described and published.

However, the post-operative management of such injuries is still controversial, with large variability between care providers. Protocols range from complete immobilization of the affected ankle and non-weightbearing to early range-of-motion (ROM) and weightbearing (WB). Studies have compared immobilization and non-WB to early ROM and WB but results have been mixed, with the most recent study demonstrating safety and advantages to protected WB and ROM at two weeks post-operatively versus non-WB and immobilization for six weeks.

The Investigators intend to expand on the studies above and propose a single-centre historical control group comparative study to compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 18, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• lateral malleolus fracture with talar shaft

• vertical shear medial malleolus fracture without superior articular involvement

• bimalleolar fracture

• any ankle fracture with posterior malleolus fragment involving 25% or less of the articular surface on the lateral ankle radiograph

• 43.B1 (pure split of distal tibia - but only if does not involve any of tibial plafond, i.e., only the vertical split of medial malleolus)

• 44.A1 (Weber A)

• 44.A2 (Bimalleolar)

• 44.A3 (posterior malleolus involvement - but only if < 25% articular involvement on lateral x-ray)

• 44-B1 (Isolated)

• 44.B2 (with medial lesion)

• 44.B3 (with medial lesion & Volkmann's #)

• closed, Gustilo-Anderson Grade I or Grade II open fractures are included

• willing and able to sign the consent

• willing and able to follow the protocol and attend follow-up visits

• able to read and understand English or have an interpreter available

Exclusion Criteria:

• skeletal immaturity demonstrated radiographically by open physes

• previous ipsilateral ankle surgery

• bilateral ankle fractures

• non ambulatory prior to injury

• inability to comply with postoperative protocol (i.e., cognitive impairment)

• medical comorbidity precluding surgery

• poorly controlled diabetes (i.e. dense neuropathy / hx of ulcers / sensory deficit)

• polytrauma patients (other injuries involving the ipsi/contralateral lower limbs, including the hip, that would interfere with mobilization/rehabilitation)

• surgical date > 14 days (time of injury to OR)

• Gustilo-Anderson grade III open fractures

• tibial plafond fractures

• active infection at the surgical site diagnosed clinically by the attending surgeon

• any ankle fracture with posterior malleolus fragment involving more than 25% of the articular surface on the lateral ankle radiograph

• any medial malleolus fracture involving the superior articular surface

• any ankle fracture requiring syndesmosis fixation

• any ankle fracture-dislocation

• incarceration

• likely problems, in the judgment of the investigator, with maintaining follow-up

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Surgery

Intervention

Other:
• Late Rehabilitation
Post-0p: Non weight-bearing and no range of motion for 2 weeks post treatment. 2 weeks: Splint removed, removable pre-fabricated walking boot applied. WB as tolerated with boot, range of motion out of boot. 6 weeks: Boot discontinued and full unrestricted and unprotected WB and ROM permitted 6 weeks:
• Early Rehabilitation
Weightbearing and range of motion as tolerated within the limitations of participant's own comfort. Use of ambulatory aides of any kind is permitted as needed without restriction. No brace or splint of any kind is permitted

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital / Fraser Health Authority	New Westminster	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Orthopaedic Research Society

Country where clinical trial is conducted

Canada, 

References & Publications (16)

Ahl T, Dalén N, Lundberg A, Bylund C. Early mobilization of operated on ankle fractures. Prospective, controlled study of 40 bimalleolar cases. Acta Orthop Scand. 1993 Feb;64(1):95-9. — View Citation

Cimino W, Ichtertz D, Slabaugh P. Early mobilization of ankle fractures after open reduction and internal fixation. Clin Orthop Relat Res. 1991 Jun;(267):152-6. — View Citation

Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. Epub 2006 Jun 30. Review. — View Citation

Dehghan N, McKee MD, Jenkinson RJ, Schemitsch EH, Stas V, Nauth A, Hall JA, Stephen DJ, Kreder HJ. Early Weightbearing and Range of Motion Versus Non-Weightbearing and Immobilization After Open Reduction and Internal Fixation of Unstable Ankle Fractures: A Randomized Controlled Trial. J Orthop Trauma. 2016 Jul;30(7):345-52. doi: 10.1097/BOT.0000000000000572. — View Citation

Egol KA, Dolan R, Koval KJ. Functional outcome of surgery for fractures of the ankle. A prospective, randomised comparison of management in a cast or a functional brace. J Bone Joint Surg Br. 2000 Mar;82(2):246-9. — View Citation

Finsen V, Saetermo R, Kibsgaard L, Farran K, Engebretsen L, Bolz KD, Benum P. Early postoperative weight-bearing and muscle activity in patients who have a fracture of the ankle. J Bone Joint Surg Am. 1989 Jan;71(1):23-7. — View Citation

Gul A, Batra S, Mehmood S, Gillham N. Immediate unprotected weight-bearing of operatively treated ankle fractures. Acta Orthop Belg. 2007 Jun;73(3):360-5. — View Citation

Hedström M, Ahl T, Dalén N. Early postoperative ankle exercise. A study of postoperative lateral malleolar fractures. Clin Orthop Relat Res. 1994 Mar;(300):193-6. — View Citation

Hoelsbrekken SE, Kaul-Jensen K, Mørch T, Vika H, Clementsen T, Paulsrud Ø, Petursson G, Stiris M, Strømsøe K. Nonoperative treatment of the medial malleolus in bimalleolar and trimalleolar ankle fractures: a randomized controlled trial. J Orthop Trauma. 2013 Nov;27(11):633-7. doi: 10.1097/BOT.0b013e31828e1bb7. — View Citation

Honigmann P, Goldhahn S, Rosenkranz J, Audigé L, Geissmann D, Babst R. Aftertreatment of malleolar fractures following ORIF -- functional compared to protected functional in a vacuum-stabilized orthesis: a randomized controlled trial. Arch Orthop Trauma Surg. 2007 Apr;127(3):195-203. Epub 2006 Dec 30. — View Citation

Lehtonen H, Järvinen TL, Honkonen S, Nyman M, Vihtonen K, Järvinen M. Use of a cast compared with a functional ankle brace after operative treatment of an ankle fracture. A prospective, randomized study. J Bone Joint Surg Am. 2003 Feb;85(2):205-11. — View Citation

Michelson JD, Magid D, McHale K. Clinical utility of a stability-based ankle fracture classification system. J Orthop Trauma. 2007 May;21(5):307-15. — View Citation

O'Sullivan ME, Bronk JT, Chao EY, Kelly PJ. Experimental study of the effect of weight bearing on fracture healing in the canine tibia. Clin Orthop Relat Res. 1994 May;(302):273-83. — View Citation

Petrisor BA, Poolman R, Koval K, Tornetta P 3rd, Bhandari M; Evidence-Based Orthopaedic Trauma Working Group. Management of displaced ankle fractures. J Orthop Trauma. 2006 Jul;20(7):515-8. Review. — View Citation

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. Review. — View Citation

van Laarhoven CJ, Meeuwis JD, van der WerkenC. Postoperative treatment of internally fixed ankle fractures: a prospective randomised study. J Bone Joint Surg Br. 1996 May;78(3):395-9. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Olerud and Molander Score	An assessment of symptoms after ankle fracture.	6 weeks post treatment
Secondary	EQ-5D	Health Related quality of life outcome measure using five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression.	2, 6 and 12 weeks post treatment
Secondary	WPAI:SHP Work Productivity and Activity Impairment Questionnaire: Specific Health Problem	A questionnaire pertaining to the effect of the participant's ankle fracture on their ability to work and perform regular activities.	2, 6 and 12 weeks post treatment
Secondary	Range of Motion	Amount of ankle dorsiflexion and plantarflexion (measured in degrees) as determined by goniometer assessment, as well as total arc of ankle ROM (dorsiflexion+ plantarflexion). This will be measured on both ankles for comparison.	2, 6 and 12 weeks post treatment
Secondary	Wound Healing	Complications regarding the surgical wound, including but not limited to signs of infection or dehiscence.	2, 6 and 12 weeks post treatment
Secondary	Fracture Healing	Radiographic assessment to determine healing, loss of reduction, loss of hardware fixation, or ankle alignment.	2, 6 and 12 weeks post treatment
Secondary	Need for Re-operation	Any issue, whether it be a wound complication or fracture complication, requiring re-operation.	2, 6 and 12 weeks post treatment
Secondary	Time to Return to Work	The chronological time between the date of surgery to the first day the participant returned to occupational duties, if currently employed and returns to work within the 12 weeks postoperative follow-up period. For the purposes of this study, students enrolled in educational activities will have their schooling treated as their occupational duty.	2, 6 and 12 weeks post treatment
Secondary	Radiographic assessment	Assessment of alignment, hardware fixation, fracture reduction and loss of reduction (defined as any shft of 2mm or more in fracture position)	2, 6 and 12 weeks post treatment