Skin Traction Versus Position Splint in Patients With Hip Fracture

NCT ID: NCT02287571

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fractures Complication of Traction Procedure Pain Splints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

elastic bandage

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Derotation splint

Intervention Type DEVICE

This group is the actual intervention group.

Interventions

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Derotation splint

This group is the actual intervention group.

Intervention Type DEVICE

elastic bandage

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role lead

Responsible Party

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BETÜL TOSUN

RN, MsN, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Betul Tosun, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Ozlem Aslan, Assoc.Prof.

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Locations

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Gulhane Military Medical Academy

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 16278188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20345356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23187429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11232658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16278174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24521802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12466869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8376442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22161361 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9828472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1618564 (View on PubMed)

Related Links

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http://www.thecomfortline.com/

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.

Other Identifiers

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B.10.4.İSM.4.06.68.49/

Identifier Type: -

Identifier Source: org_study_id