Skin Traction Versus Position Splint in Patients With Hip Fracture

The Effects of Preoperative Skin Traction and Position Splint on Pain, Comfort and Satisfaction in Patients With Hip Fracture

The aim of this prospective, randomized controlled trial is to compare the effects of preoperative skin traction and position splint on pain, comfort, complications, difficulty level of nursing interventions, satisfaction from treatment and nursing care in patients with hip fracture. The sample is comprised of 34 patients with hip fracture in each group, totally 68 patients. Skin traction and position splint were applied after block randomization. Data regarding pain, comfort, satisfaction from care, immobilization comfort, complications, time of operation and hospitalization time were collected after intervention.

Study Overview

• Status: Completed
• Conditions: Pain; Hip Fractures; Complication of Traction Procedure; Splints
• Intervention / Treatment: Device: elastic bandage; Device: Derotation splint

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06018
    • Gülhane Military Medical Academy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being inpatient who were planned the surgery due to the hip fracture (caput femur fracture, collum femur fracture, femur intertrochanteric fracture and subtrochanteric fracture) diagnosis in the Orthopedics and Traumatology Clinic
• Being 50 years old or more
• Patients who speak and literate in Turkish
• Patients who gave informed consent to participate in the study

Exclusion Criteria:

• Any condition that emerges an obstacle for verbal and written interaction during data collection phase
• Unable to perform written or verbal communication in Turkish
• Withdrawal from the study due to medical reasons or death, at his/her will prior to preoperative data collection
• Urgent non-elective surgery
• Physician decision that do accept the method of immobilization assigned to the patient as appropriate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Skin traction; Prior to hip fracture surgery, affected limb was wrapped with a special elastic bandage and pulled from the sole of the foot with a weight of 5-10% of total body weight of the patient (min 2.3 kg, max 4.5 kg).	Device: elastic bandage; This group is the routine treatment (control) valid in the clinical practice.
Experimental: Position splint; Prior to hip fracture surgery, position splint was applied to the affected limb in order to keep the extremity in the proper positon without any weight lifting.	Device: Derotation splint; This group is the actual intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain was assessed by VAS score prior to intervention, 15, 30, 60 and 120 minutes after intervention and daily from the next morning of intervention till the surgery.	up to 7 days
Comfort	Comfort was assessed by VAS score prior to intervention, 15, 30, 60 and 120 minutes after intervention and by Immobilization Comfort Questionnaire daily from the next morning of intervention till the surgery.	up to 7 days
Satisfaction from the treatment	Satisfaction from the treatment was assessed by VAS score from the next day after intervention till the surgery.	Up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complications (pressure ulcer, deep vein thrombosis, allergic skin reaction, pulmonary and urinary tract infection and constipation due to immobilization) were evaluated daily after intervention till the surgery.	Up to 7 days
Surgery duration	Time that the surgical procedure has taken was assessed.	participants were followed for the duration of surgical procedure, an average of 2 hours
Hospitalization duration	Time spent in the hospital till discharge was assessed.	participants were followed for the duration of hospital stay, an average of 2 weeks

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Investigators: Principal Investigator: Betul Tosun, RN, PhD, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi; Study Chair: Ozlem Aslan, Assoc.Prof., Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Publications and helpful links

General Publications

• Resch S, Bjarnetoft B, Thorngren KG. Preoperative skin traction or pillow nursing in hip fractures: a prospective, randomized study in 123 patients. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1191-5. doi: 10.1080/09638280500055800.
• Saygi B, Ozkan K, Eceviz E, Tetik C, Sen C. Skin traction and placebo effect in the preoperative pain control of patients with collum and intertrochanteric femur fractures. Bull NYU Hosp Jt Dis. 2010;68(1):15-7.
• Endo J, Yamaguchi S, Saito M, Itabashi T, Kita K, Koizumi W, Kawaguchi Y, Asaka T, Saegusa O. Efficacy of preoperative skin traction for hip fractures: a single-institution prospective randomized controlled trial of skin traction versus no traction. J Orthop Sci. 2013 Mar;18(2):250-5. doi: 10.1007/s00776-012-0338-1. Epub 2012 Nov 28.
• Rosen JE, Chen FS, Hiebert R, Koval KJ. Efficacy of preoperative skin traction in hip fracture patients: a prospective, randomized study. J Orthop Trauma. 2001 Feb;15(2):81-5. doi: 10.1097/00005131-200102000-00001.
• Koval KJ, Cooley MR. Clinical pathway after hip fracture. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1053-60. doi: 10.1080/09638280500056618.
• Hili S, Dawe EJ, Lindisfarne EA, Stott PM. Perioperative management of elderly patients suffering a hip fracture. Br J Hosp Med (Lond). 2014 Feb;75(2):78-82. doi: 10.12968/hmed.2014.75.2.78.
• Yip DK, Chan CF, Chiu PK, Wong JW, Kong JK. Why are we still using pre-operative skin traction for hip fractures? Int Orthop. 2002;26(6):361-4. doi: 10.1007/s00264-002-0387-8. Epub 2002 Jul 13.
• Anderson GH, Harper WM, Connolly CD, Badham J, Goodrich N, Gregg PJ. Preoperative skin traction for fractures of the proximal femur. A randomised prospective trial. J Bone Joint Surg Br. 1993 Sep;75(5):794-6. doi: 10.1302/0301-620X.75B5.8376442.
• Handoll HH, Queally JM, Parker MJ. Pre-operative traction for hip fractures in adults. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD000168. doi: 10.1002/14651858.CD000168.pub3.
• Levi N. Is preoperative tibial traction responsible for peroneal nerve palsy in patients with a fractured hip? Acta Orthop Belg. 1998 Sep;64(3):273-6.
• Finsen V, Borset M, Buvik GE, Hauke I. Preoperative traction in patients with hip fractures. Injury. 1992;23(4):242-4. doi: 10.1016/s0020-1383(05)80007-5.

Helpful Links

• immobilization comfort questionnaire that was used to evaluate the late period comfort of hip fracture patients is based on the comfort theory which was developed by Kathy Kolcaba.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 10, 2014

Study Record Updates

• Last Update Posted (Estimate): November 10, 2014
• Last Update Submitted That Met QC Criteria: November 6, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: comfort; satisfaction
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: B.10.4.ISM.4.06.68.49/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No