Total Knee Arthroplasty(TKA)NCT02067533
Flexion Versus Extension Soft Tissue Repair in Total Knee Arthroplasty
A study testing soft tissue repair in flexion position and soft tissue repair in extension position in people with Total Knee Arthroplasty(TKA) and Total Knee Replacement, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty(TKA), Total Knee Replacement
- What is being tested?
- soft tissue repair in flexion position and soft tissue repair in extension position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteIran
- Study dates
- Start not givento Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- were individuals with osteoarthritis indicated for primary Total Knee Arthroplasty
Who cannot join
- previous fracture in thigh
- previous fracture in leg
- previous high tibial osteotomy
Trial locations and contacts
1 site in 1 country.
Iran1 site
Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan, Isfahan, 8174673461
About this study
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).
- Being tested
- soft tissue repair in flexion position, soft tissue repair in extension position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft tissue repair in flexion positionProcedure or surgery
soft tissue repair in extension positionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| flexion position | Experimental | Not described Receives: Procedure: soft tissue repair in flexion position |
| extension position | Experimental | Not described Receives: Procedure: soft tissue repair in extension position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Range of Motion (ROM)
in all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.
Measured: 1 year after total knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total Knee Arthroplasty(TKA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Nemati, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067533
- Sponsor's protocol ID
- 390187
- Status last verified
- May 2015
- First submitted
- 18 Feb 2014
- Last updated
- 12 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexion Versus Extension Soft Tissue Repair in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02067533
- Acronym / sponsor ID
- 390187
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Primary completion
- Apr 2014 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Posted 12 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flexion position | Experimental | Procedure: soft tissue repair in flexion position |
| extension position | Experimental | Procedure: soft tissue repair in extension position |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- were individuals with osteoarthritis indicated for primary Total Knee Arthroplasty
Key exclusion criteria (3 listed)
- previous fracture in thigh
- previous fracture in leg
- previous high tibial osteotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| soft tissue repair in flexion position | Procedure or surgery | flexion position |
| soft tissue repair in extension position | Procedure or surgery | extension position |
Primary outcome
Knee Range of Motion (ROM)
Time frame: 1 year after total knee arthroplasty
in all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft tissue repair in flexion position and soft tissue repair in extension position in people with Total Knee Arthroplasty(TKA) and Total Knee Replacement, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Range of Motion (ROM) (time frame: 1 year after total knee arthroplasty). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.