Total Knee ArthroplastyNCT06170931
Comparison Of Outcomes After Knee Arthroplasty Using Posterior-Substituting Versus Cruciate-Retaining Prostheses
A study testing posterior cruciate ligament-retaining prostheses and posterior cruciate ligament-substituting prostheses in people with Total Knee Arthroplasty, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Total knee replacement is used in the treatment of patients with knee arthritis, rheumatoid arthritis and other knee disorders. Today, there are basically two designs; It cuts the posterior cruciate ligament (PS) and protects the posterior cruciate ligament (CR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- posterior cruciate ligament-retaining prostheses and posterior cruciate ligament-substituting prostheses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2021to 1 Jul 2024
- 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
- Patients with primary osteoarthritis of both knees
- Patients with secondary osteoarthritis of both knees
Who cannot join
- Patients with primary osteoarthritis in both knees and undergoing unilateral knee prosthesis
- Patients with secondary osteoarthritis in both knees and who underwent unilateral knee prosthesis
- Patients with primary osteoarthritis in both knees and who underwent bilateral knee prosthesis in different sessions
- Patients with secondary osteoarthritis in both knees and who underwent bilateral knee prosthetics in different sessions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, Fatih, 34093
About this study
Official title: Comparison Of Outcomes After Bilateral Simultaneous Total Knee Arthroplasty Using Posterior-Substituting Versus Cruciate-Retaining Prostheses
Total knee replacement is used in the treatment of patients with knee arthritis, rheumatoid arthritis and other knee disorders. Today, there are basically two designs; It cuts the posterior cruciate ligament (PS) and protects the posterior cruciate ligament (CR). Although there is no clear study suggesting which design is better, research on this subject has increased recently. the investigators aim is to define the superiority of these two designs over each other. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.
Read the detailed description
Total knee arthroplasty is used to treat patients with osteoarthritis, rheumatoid arthritis, and other knee disorders. Today, there are basically two primary designs; posterior cruciate Substituting (PS) and protects the posterior cruciate -Retaining (CR). However, it is still controversial which approach is good, as both CR and PS have advantages and disadvantages. Proponents of the posterior cruciate retaining system argue that it provides natural stability, wider joint range of motion, better proprioception, and better knee kinematics. In addition, proponents of the posterior cruciate substituting system argue that it provides more harmonious articulation and a wider flexion range.
As a result, although there is no clear study suggesting which design is better, research on this subject has increased recently. Our aim is to define the superiority of these two designs over each other.
Patients with the same stage of knee osteoarthritis in both knees were selected. Total knee arthroplasty was performed in the same session by making the appropriate design for the appropriate knee simultaneously. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.
- Conditions
- Total Knee Arthroplasty
- Being tested
- posterior cruciate ligament-retaining prostheses, posterior cruciate ligament-substituting prostheses
- Keywords
- Knee, total knee arthroplasty, posterior cruciate ligament-substituting, posterior cruciate ligament-retaining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior cruciate ligament-retaining prosthesesProcedure or surgery
Posterior cruciate ligament protective approach in patients with knee osteoarthritis
posterior cruciate ligament-substituting prosthesesProcedure or surgery
Posterior cruciate ligament transection approach in patients with knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| A knee of a patient with osteoarthritis of both knees | Active comparator | Posterior cruciate ligament protective approach in patients with knee osteoarthritis Receives: Procedure: posterior cruciate ligament-retaining prostheses |
| The other knee of a patient with osteoarthritis in both knees | Active comparator | Posterior cruciate ligament transection approach in patients with knee osteoarthritis Receives: Procedure: posterior cruciate ligament-substituting prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motions
Preoperative and postoperative knee flexion and extension degrees of the patients were measured.
Measured: 3 year
Secondary outcomes (2)
WOMAC Score (Score from 0 to 100)
Preoperative and postoperative WOMAC score of the patients were examined.
Measured: 3 year
OXFORD Knee Score(Score from 0 to 60)
Preoperative and postoperative OXFORD score of the patients were examined.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start14 Apr 2021
- Primary completion20 Sep 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with the same stage of knee osteoarthritis in both knees were selected. Total knee arthroplasty was performed in the same session by making the appropriate design for the appropriate knee simultaneously. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170931
- Sponsor's protocol ID
- IRB00013890
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not think it is right that the data of the patients in the study can be seen by everyone.
Publications
Li N, Tan Y, Deng Y, Chen L. Posterior cruciate-retaining versus posterior stabilized total knee arthroplasty: a meta-analysis of randomized controlled trials. Knee Surg Sports Traumatol Arthrosc. 2014 Mar;22(3):556-64. doi: 10.1007/s00167-012-2275-0. Epub 2012 Nov 3.
PubMed 23117166Rossi R, Bruzzone M, Bonasia DE, Marmotti A, Castoldi F. Evaluation of tibial rotational alignment in total knee arthroplasty: a cadaver study. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):889-93. doi: 10.1007/s00167-009-1023-6. Epub 2010 Jan 8.
PubMed 20057997Insall JN, Lachiewicz PF, Burstein AH. The posterior stabilized condylar prosthesis: a modification of the total condylar design. Two to four-year clinical experience. J Bone Joint Surg Am. 1982 Dec;64(9):1317-23. No abstract available.
PubMed 7142239In Y, Kim JM, Woo YK, Choi NY, Sohn JM, Koh HS. Factors affecting flexion gap tightness in cruciate-retaining total knee arthroplasty. J Arthroplasty. 2009 Feb;24(2):317-21. doi: 10.1016/j.arth.2007.10.022. Epub 2008 Oct 25.
PubMed 18951761Chalidis BE, Sachinis NP, Papadopoulos P, Petsatodis E, Christodoulou AG, Petsatodis G. Long-term results of posterior-cruciate-retaining Genesis I total knee arthroplasty. J Orthop Sci. 2011 Nov;16(6):726-31. doi: 10.1007/s00776-011-0152-1. Epub 2011 Sep 10.
PubMed 21909722Kim YH, Choi Y, Kwon OR, Kim JS. Functional outcome and range of motion of high-flexion posterior cruciate-retaining and high-flexion posterior cruciate-substituting total knee prostheses. A prospective, randomized study. J Bone Joint Surg Am. 2009 Apr;91(4):753-60. doi: 10.2106/JBJS.H.00805.
PubMed 19339558
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Outcomes After Bilateral Simultaneous Total Knee Arthroplasty Using Posterior-Substituting Versus Cruciate-Retaining Prostheses
- ClinicalTrials.gov ID
- NCT06170931
- Acronym / sponsor ID
- IRB00013890
- Conditions
- Total Knee Arthroplasty
- Keywords
- Knee, total knee arthroplasty, posterior cruciate ligament-substituting, posterior cruciate ligament-retaining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 14 Dec 2023 (actual)
- 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.
Total knee replacement is used in the treatment of patients with knee arthritis, rheumatoid arthritis and other knee disorders. Today, there are basically two designs; It cuts the posterior cruciate ligament (PS) and protects the posterior cruciate ligament (CR). Although there is no clear study suggesting which design is better, research on this subject has increased recently. the investigators aim is to define the superiority of these two designs over each other. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.
Detailed description
Total knee arthroplasty is used to treat patients with osteoarthritis, rheumatoid arthritis, and other knee disorders. Today, there are basically two primary designs; posterior cruciate Substituting (PS) and protects the posterior cruciate -Retaining (CR). However, it is still controversial which approach is good, as both CR and PS have advantages and disadvantages. Proponents of the posterior cruciate retaining system argue that it provides natural stability, wider joint range of motion, better proprioception, and better knee kinematics. In addition, proponents of the posterior cruciate substituting system argue that it provides more harmonious articulation and a wider flexion range.
As a result, although there is no clear study suggesting which design is better, research on this subject has increased recently. Our aim is to define the superiority of these two designs over each other.
Patients with the same stage of knee osteoarthritis in both knees were selected. Total knee arthroplasty was performed in the same session by making the appropriate design for the appropriate knee simultaneously. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with the same stage of knee osteoarthritis in both knees were selected. Total knee arthroplasty was performed in the same session by making the appropriate design for the appropriate knee simultaneously. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.
| Arm | Type | Receives |
|---|---|---|
| A knee of a patient with osteoarthritis of both knees | Active comparator | Procedure: posterior cruciate ligament-retaining prosthesesPosterior cruciate ligament protective approach in patients with knee osteoarthritis |
| The other knee of a patient with osteoarthritis in both knees | Active comparator | Procedure: posterior cruciate ligament-substituting prosthesesPosterior cruciate ligament transection approach in patients with knee osteoarthritis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary osteoarthritis of both knees
- Patients with secondary osteoarthritis of both knees
Key exclusion criteria (4 listed)
- Patients with primary osteoarthritis in both knees and undergoing unilateral knee prosthesis
- Patients with secondary osteoarthritis in both knees and who underwent unilateral knee prosthesis
- Patients with primary osteoarthritis in both knees and who underwent bilateral knee prosthesis in different sessions
- Patients with secondary osteoarthritis in both knees and who underwent bilateral knee prosthetics in different sessions.
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 |
|---|---|---|
| posterior cruciate ligament-retaining prosthesesPosterior cruciate ligament protective approach in patients with knee osteoarthritis | Procedure or surgery | A knee of a patient with osteoarthritis of both knees |
| posterior cruciate ligament-substituting prosthesesPosterior cruciate ligament transection approach in patients with knee osteoarthritis | Procedure or surgery | The other knee of a patient with osteoarthritis in both knees |
Primary outcome
Range of motions
Time frame: 3 year
Preoperative and postoperative knee flexion and extension degrees of the patients were measured.
2 secondary outcomes
WOMAC Score (Score from 0 to 100)
Time frame: 3 year
OXFORD Knee Score(Score from 0 to 60)
Time frame: 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 23117166Li N, Tan Y, Deng Y, Chen L. Posterior cruciate-retaining versus posterior stabilized total knee arthroplasty: a meta-analysis of randomized controlled trials. Knee Surg Sports Traumatol Arthrosc. 2014 Mar;22(3):556-64. doi: 10.1007/s00167-012-2275-0. Epub 2012 Nov 3.
- Background: PubMed 20057997Rossi R, Bruzzone M, Bonasia DE, Marmotti A, Castoldi F. Evaluation of tibial rotational alignment in total knee arthroplasty: a cadaver study. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):889-93. doi: 10.1007/s00167-009-1023-6. Epub 2010 Jan 8.
- Background: PubMed 7142239Insall JN, Lachiewicz PF, Burstein AH. The posterior stabilized condylar prosthesis: a modification of the total condylar design. Two to four-year clinical experience. J Bone Joint Surg Am. 1982 Dec;64(9):1317-23. No abstract available.
- Background: PubMed 18951761In Y, Kim JM, Woo YK, Choi NY, Sohn JM, Koh HS. Factors affecting flexion gap tightness in cruciate-retaining total knee arthroplasty. J Arthroplasty. 2009 Feb;24(2):317-21. doi: 10.1016/j.arth.2007.10.022. Epub 2008 Oct 25.
- Background: PubMed 21909722Chalidis BE, Sachinis NP, Papadopoulos P, Petsatodis E, Christodoulou AG, Petsatodis G. Long-term results of posterior-cruciate-retaining Genesis I total knee arthroplasty. J Orthop Sci. 2011 Nov;16(6):726-31. doi: 10.1007/s00776-011-0152-1. Epub 2011 Sep 10.
- Background: PubMed 19339558Kim YH, Choi Y, Kwon OR, Kim JS. Functional outcome and range of motion of high-flexion posterior cruciate-retaining and high-flexion posterior cruciate-substituting total knee prostheses. A prospective, randomized study. J Bone Joint Surg Am. 2009 Apr;91(4):753-60. doi: 10.2106/JBJS.H.00805.
- Individual participant dataSharing planned: No. I do not think it is right that the data of the patients in the study can be seen by everyone.
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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 posterior cruciate ligament-retaining prostheses and posterior cruciate ligament-substituting prostheses in people with Total Knee Arthroplasty, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 6 Dec 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Range of motions (time frame: 3 year). 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 NCT06170931, which also lists 6 linked publications.
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 6 Dec 2024.