Type II Pediatric Supracondylar Humerus Fracture Management and Outcomes: A Prospective Multi-centre Cohort Study

NCT02963233 | Unknown

• 1 other identifier: H15-00835
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 13

Brief Summary

The treatment of pediatric supracondylar humerus fractures is controversial, but despite the injury's high incidence there is a lack of high level evidence to guide operative versus non-operative decision making for displaced fractures with an intact posterior cortex (Gartland Type II). This study aims to prospectively compare clinical, functional, and radiographic outcomes between operatively and non-operatively treated patients using a prospective multi-centre cohort design.

Conditions

Trauma; Fracture;Elbow

Outcome Measures

Primary Outcomes (1)

• Change in Lateral Humerocapitellar Angle

  Change in the LHCA over the period of immobilization is the primary outcome being measured in this study, and will be measured on all radiographs. Maintenance of fracture reduction is assessed by the change in the LHCA between these two radiographs. This angle primarily assesses the reduction in the sagittal plane and thus is most sensitive to flexion and extension. The normal LHCA is considered to be 30 degrees of anterior angulation. It has been shown that with changes of less than 10 degrees, good elbow function can still be expected.

  3 months

Secondary Outcomes (2)

• Baumann's Angle

  3 months

• Flynn's Elbow Score

  1 year

Other Outcomes (1)

• Complications/Conversion to Operative Treatment/Revision Operation

  1 year

Study Arms (2)

Non-operative Group

Patients treated within the non-operative group will be treated with gentle reduction by the orthopaedic surgery team in the emergency department under procedural sedation. Immobilization and maintenance of reduction will be obtained through either taping of the elbow in a flexed (100-110 degree) and pronated position or through long-arm casting at 90 degrees of flexion. Immobilization type and position will be noted.

Procedure: Non-operative reduction and immobilization

Operative Group

Patients treated operatively will be largely treated with closed reduction and percutaneous pinning with 2-3 laterally-based k-wires, followed by long-arm immobilization. Immobilization type and position will be noted.

Procedure: Closed reduction and percutaneous pinning and immobilization

Interventions

Closed reduction and percutaneous pinning and immobilization PROCEDURE

Operative Group

Non-operative reduction and immobilization PROCEDURE

Non-operative Group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients identified with a closed, isolated Gartland Type II extension-type supracondylar humerus fracture between 2-12 years, recruited within their acute treatment phase between initial injury presentation either to the emergency department or the orthopaedic clinic and 6 weeks post-injury.

You may qualify if:

• Age 2-12 years
• Isolated supracondylar humerus fracture
• Gartland Type II extension-type fracture
• Closed injury

You may not qualify if:

• Neurovascular compromise
• Underlying musculoskeletal disorder

Sponsors & Collaborators

• British Columbia Children's Hospital: lead
• Pediatric Orthopaedic Society of North America: collaborator

Study Sites (13)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

NOT YET RECRUITING

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

NOT YET RECRUITING

Prince George Surgery Centre

Prince George, British Columbia, V2L 2J9, Canada

NOT YET RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

NOT YET RECRUITING

Janeway Children's Hospital

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

NOT YET RECRUITING

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

NOT YET RECRUITING

Children's Hospital at London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

NOT YET RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

NOT YET RECRUITING

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

NOT YET RECRUITING

La Cité Médical Québec

Québec, Quebec, G1V 4T3, Canada

NOT YET RECRUITING

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

NOT YET RECRUITING

Related Publications (18)

• Mulpuri K, Hosalkar H, Howard A. AAOS clinical practice guideline: the treatment of pediatric supracondylar humerus fractures. J Am Acad Orthop Surg. 2012 May;20(5):328-30. doi: 10.5435/JAAOS-20-05-328. No abstract available.

  PMID: 22553105 BACKGROUND

• Abzug JM, Herman MJ. Management of supracondylar humerus fractures in children: current concepts. J Am Acad Orthop Surg. 2012 Feb;20(2):69-77. doi: 10.5435/JAAOS-20-02-069.

  PMID: 22302444 BACKGROUND

• Bashyal RK, Chu JY, Schoenecker PL, Dobbs MB, Luhmann SJ, Gordon JE. Complications after pinning of supracondylar distal humerus fractures. J Pediatr Orthop. 2009 Oct-Nov;29(7):704-8. doi: 10.1097/BPO.0b013e3181b768ac.

  PMID: 20104149 BACKGROUND

• Blasier RD. Gartland type-II supracondylar humeral fractures in children: commentary on an article by Luis Moraleda, MD, et al.: "Natural history of unreduced Gartland type-II supracondylar fractures of the humerus in children. a two to thirteen-year follow-up study". J Bone Joint Surg Am. 2013 Jan 2;95(1):e7. doi: 10.2106/jbjs.l.01324. No abstract available.

  PMID: 23405412 BACKGROUND

• Carson S, Woolridge DP, Colletti J, Kilgore K. Pediatric upper extremity injuries. Pediatr Clin North Am. 2006 Feb;53(1):41-67, v. doi: 10.1016/j.pcl.2005.10.003.

  PMID: 16487784 BACKGROUND

• Cheng JC, Lam TP, Shen WY. Closed reduction and percutaneous pinning for type III displaced supracondylar fractures of the humerus in children. J Orthop Trauma. 1995;9(6):511-5. doi: 10.1097/00005131-199509060-00009.

  PMID: 8592265 BACKGROUND

• Daltroy LH, Liang MH, Fossel AH, Goldberg MJ. The POSNA pediatric musculoskeletal functional health questionnaire: report on reliability, validity, and sensitivity to change. Pediatric Outcomes Instrument Development Group. Pediatric Orthopaedic Society of North America. J Pediatr Orthop. 1998 Sep-Oct;18(5):561-71. doi: 10.1097/00004694-199809000-00001.

  PMID: 9746401 BACKGROUND

• Fitzgibbons PG, Bruce B, Got C, Reinert S, Solga P, Katarincic J, Eberson C. Predictors of failure of nonoperative treatment for type-2 supracondylar humerus fractures. J Pediatr Orthop. 2011 Jun;31(4):372-6. doi: 10.1097/BPO.0b013e31821adca9.

  PMID: 21572273 BACKGROUND

• Flynn JC, Matthews JG, Benoit RL. Blind pinning of displaced supracondylar fractures of the humerus in children. Sixteen years' experience with long-term follow-up. J Bone Joint Surg Am. 1974 Mar;56(2):263-72. No abstract available.

  PMID: 4375679 BACKGROUND

• Hadlow AT, Devane P, Nicol RO. A selective treatment approach to supracondylar fracture of the humerus in children. J Pediatr Orthop. 1996 Jan-Feb;16(1):104-6. doi: 10.1097/00004694-199601000-00021.

  PMID: 8747365 BACKGROUND

• Lins RE, Simovitch RW, Waters PM. Pediatric elbow trauma. Orthop Clin North Am. 1999 Jan;30(1):119-32. doi: 10.1016/s0030-5898(05)70066-3.

  PMID: 9882730 BACKGROUND

• Moraleda L, Valencia M, Barco R, Gonzalez-Moran G. Natural history of unreduced Gartland type-II supracondylar fractures of the humerus in children: a two to thirteen-year follow-up study. J Bone Joint Surg Am. 2013 Jan 2;95(1):28-34. doi: 10.2106/jbjs.l.00132.

  PMID: 23405411 BACKGROUND

• Omid R, Choi PD, Skaggs DL. Supracondylar humeral fractures in children. J Bone Joint Surg Am. 2008 May;90(5):1121-32. doi: 10.2106/JBJS.G.01354.

  PMID: 18451407 BACKGROUND

• O'Hara LJ, Barlow JW, Clarke NM. Displaced supracondylar fractures of the humerus in children. Audit changes practice. J Bone Joint Surg Br. 2000 Mar;82(2):204-10.

  PMID: 10755427 BACKGROUND

• Parikh SN, Wall EJ, Foad S, Wiersema B, Nolte B. Displaced type II extension supracondylar humerus fractures: do they all need pinning? J Pediatr Orthop. 2004 Jul-Aug;24(4):380-4. doi: 10.1097/00004694-200407000-00007.

  PMID: 15205619 BACKGROUND

• Pirone AM, Graham HK, Krajbich JI. Management of displaced extension-type supracondylar fractures of the humerus in children. J Bone Joint Surg Am. 1988 Jun;70(5):641-50.

  PMID: 3392056 BACKGROUND

• Roberts L, Strelzow J, Schaeffer EK, Reilly CW, Mulpuri K. Nonoperative Treatment of Type IIA Supracondylar Humerus Fractures: Comparing 2 Modalities. J Pediatr Orthop. 2018 Nov/Dec;38(10):521-526. doi: 10.1097/BPO.0000000000000863.

  PMID: 27636909 BACKGROUND

• Williamson DM, Cole WG. Treatment of selected extension supracondylar fractures of the humerus by manipulation and strapping in flexion. Injury. 1993 Apr;24(4):249-52. doi: 10.1016/0020-1383(93)90180-e.

  PMID: 8325683 BACKGROUND

Related Links

• Brant R. Inference for Means: Comparing Two Independent Samples. University of British Columbia, Department of Statistics. http://www.stat.ubc.ca/\~rollin/stats/ssize/n2.html Last accessed Oct 31, 2014.

MeSH Terms

Conditions

Wounds and Injuries; Elbow Fractures

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Tammie Teo

CONTACT

6048752359; Tammie.Teo@cw.bc.ca

Emily Schaeffer, PhD

CONTACT

6048752359; Emily.Schaeffer@cw.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 15, 2016
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)