Osteoarthritis, KneeNCT02450409
A New Technique to Produce Anatomical Alignment Results With Less Midflexion Instability in Total Knee Arthroplasty
A study testing Implantation of TKA using the gap technique and Implantation of TKA using anatomical alignment in people with Osteoarthritis, Knee, run by University of Jena at 1 site in Germany.
Trial summary
Beside the current standard of classical mechanical alignment of total knee replacements, increased interest is being shown in anatomical alignment. However, no surgical technique is capable of controlling the stability of the joint in midflexion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Implantation of TKA using the gap technique and Implantation of TKA using anatomical alignment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients were to undergo surface replacement due to primary osteoarthritis of the knee
Who cannot join
- Joints that had undergone open surgery beforehand (e.g. high tibial osteotomy, fracture treatment) were excluded.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Friedrich-Schiller University Jena, Campus Eisenberg
Eisenberg, Eisenberg, 07607
Georg Matziolis, Prof. Dr., +49 36691 81010, g.matziolis@krankenhaus-eisenberg.de
About this study
Beside the current standard of classical mechanical alignment of total knee replacements, increased interest is being shown in anatomical alignment. However, no surgical technique is capable of controlling the stability of the joint in midflexion. The purpose of the present study was to present and evaluate a new surgical technique, which aims to reduce the need for soft-tissue release and optimize stability in midflexion.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Implantation of TKA using the gap technique, Implantation of TKA using anatomical alignment
- Keywords
- Total knee arthroplasty, Midflexion instability, Gap technique, Anatomical alignment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of TKA using the gap techniqueProcedure or surgery
Implantation of total knee arthroplasty using a specific operative technique (GT) serving as control.
Implantation of TKA using anatomical alignmentProcedure or surgery
Implantation of total knee arthroplasty using a specific operative technique (AA) being experimental.
| Study group | Role | What they receive |
|---|---|---|
| gap technique (GT) | Active comparator | The patients receive a total knee arthroplasty using the established "gap technique" (gold standard serving as control). The intervention is the implantation of a total knee arthroplasty with this specific technique.
Implantation of TKA using the gap technique is the intervention. Intervention is not a drug but a specific operative technique. Receives: Procedure: Implantation of TKA using the gap technique |
| anatomical alignment (AA) | Experimental | The patients receive a total knee arthroplasty using the new "anatomical alignment technique" (experimental). The intervention is the implantation of a total knee arthroplasty with this specific technique.
Implantation of TKA using anatomical alignment Intervention is not a drug but a specific operative technique. Receives: Procedure: Implantation of TKA using anatomical alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion
The outcome measures are given in mm.
Measured: intraoperatively immediately before implantation of definite implants.
Secondary outcomes (1)
performance of soft tissue release (yes / no) and extend of release if done.
The surgeon documents postoeperatively if a soft tissue release was done or not and what extend a release had.
The outcome measure is given in numbers (0 ... 4).
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJan 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Matziolis, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450409
- Sponsor's protocol ID
- REK_2015_1
- Status last verified
- May 2015
- First submitted
- 11 May 2015
- Last updated
- 21 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Technique to Produce Anatomical Alignment Results With Less Midflexion Instability in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02450409
- Acronym / sponsor ID
- REK_2015_1
- Conditions
- Osteoarthritis, Knee
- Keywords
- Total knee arthroplasty, Midflexion instability, Gap technique, Anatomical alignment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Beside the current standard of classical mechanical alignment of total knee replacements, increased interest is being shown in anatomical alignment. However, no surgical technique is capable of controlling the stability of the joint in midflexion. The purpose of the present study was to present and evaluate a new surgical technique, which aims to reduce the need for soft-tissue release and optimize stability in midflexion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gap technique (GT) | Active comparator | Procedure: Implantation of TKA using the gap techniqueThe patients receive a total knee arthroplasty using the established "gap technique" (gold standard serving as control). The intervention is the implantation of a total knee arthroplasty with this specific technique. Implantation of TKA using the gap technique is the intervention. Intervention is not a drug but a specific operative technique. |
| anatomical alignment (AA) | Experimental | Procedure: Implantation of TKA using anatomical alignmentThe patients receive a total knee arthroplasty using the new "anatomical alignment technique" (experimental). The intervention is the implantation of a total knee arthroplasty with this specific technique. Implantation of TKA using anatomical alignment Intervention is not a drug but a specific operative technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patients were to undergo surface replacement due to primary osteoarthritis of the knee
Key exclusion criteria (1 listed)
- Joints that had undergone open surgery beforehand (e.g. high tibial osteotomy, fracture treatment) were excluded.
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 |
|---|---|---|
| Implantation of TKA using the gap techniqueImplantation of total knee arthroplasty using a specific operative technique (GT) serving as control. | Procedure or surgery | gap technique (GT) |
| Implantation of TKA using anatomical alignmentImplantation of total knee arthroplasty using a specific operative technique (AA) being experimental. | Procedure or surgery | anatomical alignment (AA) |
Primary outcome
Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion
Time frame: intraoperatively immediately before implantation of definite implants.
The outcome measures are given in mm.
1 secondary outcome
performance of soft tissue release (yes / no) and extend of release if done.
Time frame: intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of TKA using the gap technique and Implantation of TKA using anatomical alignment in people with Osteoarthritis, Knee, run by University of Jena at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 21 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georg Matziolis, Prof. Dr. (+49 36691 81010, g.matziolis@krankenhaus-eisenberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion (time frame: intraoperatively immediately before implantation of definite implants.). 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 21 May 2015.