OsteoarthritisNCT02160977

Proprioception of the Knee Post MIS TKA and MIS-QS TKA

A study testing total knee arthroplasty in people with Osteoarthritis, run by Jia-kuo yu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 70 years
Conditions the study is for: Osteoarthritis
What is being tested?: total knee arthroplasty
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteChina
Study dates: Oct 2011to Dec 2012
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 Up to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Clinical diagnosis of osteoarthritis
Indication of TKA

Who cannot join

Bilateral total knee replacements
Rheumatoid arthritis
Genu valgus over than 10 degrees and genu varum over 15 degrees
ROM (Range of motion) of preoperative knee joint less than 100 degree.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University Third Hospital
Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: Prospective Randomized Comparative Study on the Proprioception of the Knee Post MIS TKA (Minimally Invasive Surgery Total Knee Arthroplasty) and MIS-QS(Quadriceps Sparing ) TKA

If the proprioception of the affected knee post total knee arthroplasty (TKA) can recover earlier, it will accelerate the regaining of motion control ability and motion control accuracy of the TKA patients. This study compared the proprioception difference of the post operation knees between the MIS-QS TKA group and the MIS TKA group.The differences of proprioception recovery were analyzed following the two different TKA procedures and the advantages of MIS-QS TKA in the recovery of knee. proprioception were discussed.

Read the detailed description

Patients were scheduled prospectively to undergo total knee arthroplasties were randomly assigned to receive either a MIS-QS TKA or a MIS TKA. Proprioception of the knee position sense was assessed by the knee angle reproduction test (10~20 degree, 30~40 degree, 80~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation. Paired two-tailed t tests with a level of significance of p < 0.05 were used to assess the effect of the different arthroplasty procedure on the postoperative knee joint proprioception for all subjects.

Conditions: Osteoarthritis
Being tested: total knee arthroplasty
Keywords: Surgical procedures, Minimally invasive, Arthroplasty, Knee
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

total knee arthroplastyProcedure or surgery
Also called total knee replacement

Study groups in NCT02160977
Study group	Role	What they receive
QS-TKA	Experimental	patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA) Receives: Procedure: total knee arthroplasty
MIS-TKA	Active comparator	patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA) Receives: Procedure: total knee arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

Proprioception of the Knee Post Operation
Proprioception of the knee position sense was assessed by the knee angle reproduction test (10~20 degree, 30~40 degree, 80~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation.
Scale Name:degree scale range:0~180 degree,and a higher values represent a worse outcome
Measured: six months

Secondary outcomes (2)

HSS(Hospital for Special Surgery) Score of the Knee Joint
Scale Name:score scale range:0~100,and a higher values represent a better outcome
Measured: 6 months
VAS(Visual Analogue Scale/Score) of the Knee Joint
Scale Name:score scale range:0~100,and a higher values represent a worse outcome
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Dec 2012

First posted11 Jun 2014 (estimated)
Study startOct 2011
Primary completionJun 2012
Study completionDec 2012

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 OsteoarthritisStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02160977
Sponsor's protocol ID: QS-YU
Status last verified: Jul 2014
First submitted: 5 Jun 2014
Last updated: 4 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Comparative Study on the Proprioception of the Knee Post MIS TKA (Minimally Invasive Surgery Total Knee Arthroplasty) and MIS-QS(Quadriceps Sparing ) TKA
ClinicalTrials.gov ID: NCT02160977
Acronym / sponsor ID: QS-YU
Conditions: Osteoarthritis
Keywords: Surgical procedures, Minimally invasive, Arthroplasty, Knee
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Jia-kuo yuUniversity, hospital or other
Study start: Oct 2011
Primary completion: Jun 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 11 Jun 2014 (estimated)
Results: Posted 4 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
QS-TKA	Experimental	Procedure: total knee arthroplastypatients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
MIS-TKA	Active comparator	Procedure: total knee arthroplastypatients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)

Who may qualify

Ages: Up to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Clinical diagnosis of osteoarthritis
Indication of TKA

Key exclusion criteria (4 listed)

Bilateral total knee replacements
Rheumatoid arthritis
Genu valgus over than 10 degrees and genu varum over 15 degrees
ROM (Range of motion) of preoperative knee joint less than 100 degree.

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
total knee arthroplastyAlso: total knee replacement	Procedure or surgery	MIS-TKA, QS-TKA

Primary outcome

Proprioception of the Knee Post Operation
Time frame: six months
Proprioception of the knee position sense was assessed by the knee angle reproduction test (10~20 degree, 30~40 degree, 80~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation. Scale Name:degree scale range:0~180 degree,and a higher values represent a worse outcome

2 secondary outcomes

HSS(Hospital for Special Surgery) Score of the Knee Joint
Time frame: 6 months
VAS(Visual Analogue Scale/Score) of the Knee Joint
Time frame: 6 months

Results and safety

Results posted to the registry on 4 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MIS-TKA	45	45
QS-TKA	45	45

Primary outcome: Proprioception of the Knee Post Operation

Time frame: six months. Mean (Standard Error). Unit: units on a scale

Measure	MIS-TKA n = 42	QS-TKA n = 42
preoperative proprioception at 10 ~ 20 degree	10.3 (6.8)	6.3 (2.9)
preoperative proprioception at 30 ~ 40 degree	7.3 (3.2)	6.4 (2.1)
preoperative proprioception at 80 ~ 90 degree	8.0 (3.2)	7.0 (3.7)
one week after operation at 10 ~ 20 degree	8.6 (2.8)	5.0 (1.3)
one week after operation at 30 ~40 degree	6.3 (1.9)	4.0 (1.5)
six weeks after operation at 10 ~ 20 degree	7.7 (3.3)	5.2 (3.1)
six weeks after operation at 30 ~ 40 degree	11.6 (4.7)	8.3 (5.1)
six weeks after operation at 80 ~ 90 degree	8.1 (2.8)	5.8 (2.3)

MIS-TKA vs QS-TKA: p <0.05, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Six months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MIS-TKA	0 of 42 (0%)	0 of 42 (0%)	Not reported
QS-TKA	0 of 42 (0%)	0 of 42 (0%)	Not reported

Limitations and caveats (from the sponsor): Limitation was that the position reconstruction measurement mainly measures the difference of the reconstructed flex angle, while the reflex circuit and motion perception of the knee was not measured.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
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.

JIa-Kuo Yu, Doctor study chair

Peking University Third Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing total knee arthroplasty in people with Osteoarthritis, run by Jia-kuo yu at 1 site in China.

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 2 inclusion and 4 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 4 Aug 2014. 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 China. 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 4 Aug 2014). 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?

Proprioception of the Knee Post Operation (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02160977.

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 4 Aug 2014.