NCT02067533

Brief Summary

The purpose of the present study is to determine the influence of position of soft tissue repair (flexion versus extension) in post operative range of motion(ROM) and functional outcome in patients who underwent primary total knee arthroplasty (TKA).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 12, 2015

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

First QC Date

February 18, 2014

Results QC Date

December 25, 2014

Last Update Submit

May 8, 2015

Conditions

Total Knee Arthroplasty(TKA)Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

  • Knee Range of Motion (ROM)

    in all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.

    1 year after total knee arthroplasty

Study Arms (2)

flexion position

EXPERIMENTAL
Procedure: soft tissue repair in flexion position

extension position

EXPERIMENTAL
Procedure: soft tissue repair in extension position

Interventions

soft tissue repair in flexion positionPROCEDURE
flexion position
soft tissue repair in extension positionPROCEDURE
extension position

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • were individuals with osteoarthritis indicated for primary Total Knee Arthroplasty

You may not qualify if:

  • previous fracture in thigh
  • previous fracture in leg
  • previous high tibial osteotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran

Isfahan, Isfahan, 8174673461, Iran

Location

Results Point of Contact

Title
Amin Nemati
Organization
Isfahan University of Medical Sciences
nemati@med.mui.ac.ir
00989131009918

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic surgery resident,Orthopedic department,Alzahra hospital,Isfahan University of Medical Sciences,Isfahan,Iran

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 20, 2014

Primary Completion

April 1, 2014

Last Updated

May 12, 2015

Results First Posted

May 12, 2015

Record last verified: 2015-05

Locations

IR(1)