Skin Traction Versus Position Splint in Patients With Hip Fracture

NCT02287571 | Completed DMC

• 1 other identifier: B.10.4.İSM.4.06.68.49/
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures; Complication of Traction Procedure; Pain; Splints

Keywords

comfort; satisfaction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Complications

  Up to 7 days

• Surgery duration

  participants were followed for the duration of surgical procedure, an average of 2 hours

• Hospitalization duration

  participants were followed for the duration of hospital stay, an average of 2 weeks

Study Arms (2)

Skin traction

ACTIVE COMPARATOR

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

Position splint

EXPERIMENTAL

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

Interventions

Derotation splint DEVICE

This group is the actual intervention group.

Position splint

elastic bandage DEVICE

This group is the routine treatment (control) valid in the clinical practice.

Skin traction

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (1)

Gulhane Military Medical Academy

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 16278188 BACKGROUND

• 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.

  PMID: 20345356 BACKGROUND

• 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.

  PMID: 23187429 BACKGROUND

• 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.

  PMID: 11232658 BACKGROUND

• 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.

  PMID: 16278174 BACKGROUND

• 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.

  PMID: 24521802 BACKGROUND

• 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.

  PMID: 12466869 BACKGROUND

• 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.

  PMID: 8376442 BACKGROUND

• 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.

  PMID: 22161361 BACKGROUND

• 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.

  PMID: 9828472 BACKGROUND

• 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.

  PMID: 1618564 BACKGROUND

Related 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.

MeSH Terms

Conditions

Hip Fractures; Pain; Personal Satisfaction

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Betul Tosun, RN, PhD

  Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

  PRINCIPAL INVESTIGATOR

• Ozlem Aslan, Assoc.Prof.

  Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MsN, PhD

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 10, 2014
• Study Start: March 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 10, 2014

Record last verified: 2014-11

Locations

TU (1)