ClinicalTrials.gg
CompletedNCT02067533Updated May 12, 2015Results posted

Flexion Versus Extension Soft Tissue Repair in Total Knee Arthroplasty

An interventional study of soft tissue repair in flexion position and soft tissue repair in extension position in Total Knee Arthroplasty(TKA) and Total Knee Replacement, sponsored by Isfahan University of Medical Sciences. Completed at 1 site in Iran. Per ClinicalTrials.gov, last updated 2015-05-12.

Sponsored by Isfahan University of Medical Sciences · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
91
Sex
All
01

Study 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).

02

Conditions studied

  • Total Knee Arthroplasty(TKA)
  • Total Knee Replacement
03

In context

Lead sponsor

Isfahan University of Medical Sciences is the lead sponsor of 149 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • were individuals with osteoarthritis indicated for primary Total Knee Arthroplasty

Exclusion criteria

Exclusion Criteria:

  • previous fracture in thigh
  • previous fracture in leg
  • previous high tibial osteotomy
05

Study design

Phase
Not applicable
Enrollment
91 participants (actual)

Study arms

  • Experimental
    flexion position

    Procedure: soft tissue repair in flexion position

  • Experimental
    extension position

    Procedure: soft tissue repair in extension position

Interventions

  • Proceduresoft tissue repair in flexion position
  • Proceduresoft tissue repair in extension position
06

What researchers measure

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.

    Time frame: 1 year after total knee arthroplasty

07

Results

Posted May 12, 2015

Participant flow

Participant flow — Overall Study
MilestoneFlexion PositionExtension Position
Started4546
Completed4144
Not completed42
Withdrew: Lost to follow-up42

Outcome measures

PrimaryKnee Range of Motion (ROM)

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

Time frame:
1 year after total knee arthroplasty
Reported as:
Mean · degree
Knee Range of Motion (ROM)
degreeFlexion PositionExtension Position
Knee Range of Motion (ROM)119 ± 6.8120 ± 5.4

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Flexion Position—0/41 (0%)0/41 (0%)
Extension Position—0/44 (0%)0/44 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Flexion PositionExtension PositionTotal
Mean66.7 ± 8.667.5 ± 7.667.14 ± 4.7
Sex: Female, Male
Sex: Female, Male(Participants)Flexion PositionExtension PositionTotal
Female344074
Male11617
08

Study locations

1 site
  • Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
    Isfahan, Isfahan 8174673461, Iran
09

Timeline

Tracking since Sep 25, 2026

Results were first posted in May 2015, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2014
First posted
Feb 20, 2014
Primary completionActual
Apr 2014
Results first posted
May 12, 2015
Last update
May 12, 2015
What these dates mean
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02067533
Responsible party
Amin Nemati (Orthopedic surgery resident,Orthopedic department,Alzahra hospital,Isfahan University of Medical Sciences,Isfahan,Iran, Isfahan University of Medical Sciences) — Principal investigator
First posted
Feb 20, 2014
Primary completion
Apr 2014
Results posted
May 12, 2015
Last update
May 12, 2015
View the source record on ClinicalTrials.gov ↗

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