Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture

NCT02029170 | Unknown DMC

• 1 other identifier: HUKSHHOS
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 4

Brief Summary

Unstable ankle fractures are commonly treated operatively. After operative reduction and fixation of the fractures, there are varying rehabilitation regimes that include non-weightbearing for 6 weeks with active range of motion exercise in a removal cast or brace, or early protected weightbearing in a rigid cast. Several papers reported that early weightbearing may decrease ankle stiffness, muscle and bone atrophy, and aids in early return to activities. However, early weightbearing may have the risk of displacement of the fixed fractures. Rehabilitation after operative treatment of an ankle fracture is still not clear. We hypothesized that the ankle function assessed on 12 months after operation of an ankle fracture with early weightbearing is not inferior to non-weightbearing but is superior to non-weightbearing with respect to time to return to normal daily life and time to full weightbearing.

Conditions

Ankle Fracture; Rehabilitation

Keywords

ankle fracture; weightbearing; cast

Outcome Measures

Primary Outcomes (1)

• The Olerud-Molander ankle function score

  The Olerud-Molander score is a most widely used validated scale to assess ankle function after an ankle fracture. It is a self-administered patient questionnaire with a score of zero (totally impaired) to 100 (completely unimpaired) and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living.

  12 months post-operative

Secondary Outcomes (1)

• Time to return to preinjury activity, time to full weightbearing, patients' subjective satisfactions, Visual analogue Scale (VAS)

  upto 12 months

Other Outcomes (1)

• Number of Participants with hardware failure, reduction loss, delayed union or non-union are assessed

  Up to 12 month

Study Arms (2)

Early weightbearing

EXPERIMENTAL

After operative reduction and fixation of the fractures, patients allocated to the early weightbearing group start weightbearing after stitch out at 2 weeks and the application of a walking cast.

Procedure: Early weightbearing

Non-weightbearing

ACTIVE COMPARATOR

Patients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative

Procedure: Non-weightbearing

Interventions

Early weightbearing PROCEDURE

Patients allocated to early weightbearing group are allowed to weightbear after stitch out and application of a walking cast

Early weightbearing

Non-weightbearing PROCEDURE

Patients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative

Non-weightbearing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unstable ankle fracture requiring open reduction and internal fixation
• age between 18 and 65 years
• satisfactory reduction and stable fixation after operation.

You may not qualify if:

• open fractures
• comminuted fractures
• pathologic fractures
• Pilon fractures
• Trimalleolar fractures
• fracture dislocations
• Fractures requiring syndesmotic screw fixation
• Fractures with cartilage injuries or unstable fixation or any other conditions preventing from early weightbearing.
• Patients with diabetes or neuroarthropathy
• Patients with obesity (BMI \>30, weight \>100 kg)
• Any other conditions that are expected to prevent the patients from following the study protocol

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (4)

Hallym University Sacred Heart Hospital, Hallym University College of Medicine

Anyang-si, Gyeonggi-do, 431-070, South Korea

RECRUITING

Sanbon Hospital, Wonkwang University College of Medicine

Gunpo, Gyeongi, 435-040, South Korea

RECRUITING

CHA Bundang Medical Center, CHA University

Seongnam, Gyeongi, 463-712, South Korea

RECRUITING

Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Seoul, 150-950, South Korea

RECRUITING

Related Publications (17)

• Ahl T, Dalen N, Holmberg S, Selvik G. Early weight bearing of displaced ankle fractures. Acta Orthop Scand. 1987 Oct;58(5):535-8. doi: 10.3109/17453678709146394.

  PMID: 3425284 BACKGROUND

• Aktas S, Kocaoglu B, Gereli A, Nalbantodlu U, Guven O. Incidence of chondral lesions of talar dome in ankle fracture types. Foot Ankle Int. 2008 Mar;29(3):287-92. doi: 10.3113/FAI.2008.0287.

  PMID: 18348824 BACKGROUND

• Bostman OM. Body-weight related to loss of reduction of fractures of the distal tibia and ankle. J Bone Joint Surg Br. 1995 Jan;77(1):101-3.

  PMID: 7822361 BACKGROUND

• Burwell HN, Charnley AD. The treatment of displaced fractures at the ankle by rigid internal fixation and early joint movement. J Bone Joint Surg Br. 1965 Nov;47(4):634-60. No abstract available.

  PMID: 5846764 BACKGROUND

• Dogra AS, Rangan A. Early mobilisation versus immobilisation of surgically treated ankle fractures. Prospective randomised control trial. Injury. 1999 Aug;30(6):417-9. doi: 10.1016/s0020-1383(99)00110-2.

  PMID: 10645355 BACKGROUND

• 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.

  PMID: 2492286 BACKGROUND

• Ganesh SP, Pietrobon R, Cecilio WA, Pan D, Lightdale N, Nunley JA. The impact of diabetes on patient outcomes after ankle fracture. J Bone Joint Surg Am. 2005 Aug;87(8):1712-8. doi: 10.2106/JBJS.D.02625.

  PMID: 16085609 BACKGROUND

• Lehtonen H, Jarvinen TL, Honkonen S, Nyman M, Vihtonen K, Jarvinen 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. doi: 10.2106/00004623-200302000-00004.

  PMID: 12571295 BACKGROUND

• Mak KH, Chan KM, Leung PC. Ankle fracture treated with the AO principle--an experience with 116 cases. Injury. 1985 Jan;16(4):265-72. doi: 10.1016/s0020-1383(85)80017-6.

  PMID: 3967916 BACKGROUND

• Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.

  PMID: 6437370 BACKGROUND

• Pagliaro AJ, Michelson JD, Mizel MS. Results of operative fixation of unstable ankle fractures in geriatric patients. Foot Ankle Int. 2001 May;22(5):399-402. doi: 10.1177/107110070102200507.

  PMID: 11428758 BACKGROUND

• Simanski CJ, Maegele MG, Lefering R, Lehnen DM, Kawel N, Riess P, Yucel N, Tiling T, Bouillon B. Functional treatment and early weightbearing after an ankle fracture: a prospective study. J Orthop Trauma. 2006 Feb;20(2):108-14. doi: 10.1097/01.bot.0000197701.96954.8c.

  PMID: 16462563 BACKGROUND

• Starkweather MP, Collman DR, Schuberth JM. Early protected weightbearing after open reduction internal fixation of ankle fractures. J Foot Ankle Surg. 2012 Sep-Oct;51(5):575-8. doi: 10.1053/j.jfas.2012.05.022. Epub 2012 Jul 20.

  PMID: 22819002 BACKGROUND

• Strauss EJ, Frank JB, Walsh M, Koval KJ, Egol KA. Does obesity influence the outcome after the operative treatment of ankle fractures? J Bone Joint Surg Br. 2007 Jun;89(6):794-8. doi: 10.1302/0301-620X.89B6.18356.

  PMID: 17613507 BACKGROUND

• Tropp H, Norlin R. Ankle performance after ankle fracture: a randomized study of early mobilization. Foot Ankle Int. 1995 Feb;16(2):79-83. doi: 10.1177/107110079501600205.

  PMID: 7767451 BACKGROUND

• Tunturi T, Kemppainen K, Patiala H, Suokas M, Tamminen O, Rokkanen P. Importance of anatomical reduction for subjective recovery after ankle fracture. Acta Orthop Scand. 1983 Aug;54(4):641-7. doi: 10.3109/17453678308992903.

  PMID: 6422695 BACKGROUND

• Park JY, Kim BS, Kim YM, Cho JH, Choi YR, Kim HN. Early Weightbearing Versus Nonweightbearing After Operative Treatment of an Ankle Fracture: A Multicenter, Noninferiority, Randomized Controlled Trial. Am J Sports Med. 2021 Aug;49(10):2689-2696. doi: 10.1177/03635465211026960. Epub 2021 Jul 12.

  PMID: 34251882 DERIVED

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Hyong Nyun Kim, MD, PhD

  Kangnam Sacred Heart Hospital, Hallym University College of Medicine

  STUDY CHAIR

• Hyong Nyun Kim, MD, PhD

  Kangnam Sacred Heart Hospital, Hallym University College of Medicine

  STUDY DIRECTOR

Central Study Contacts

Hyong Nyun Kim, MD, PhD

CONTACT

+82-10-6377-8201; hyongnyun@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, MD, PhD

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 7, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 9, 2015

Record last verified: 2015-10

Locations

KR (4)