Total Knee AnthroplastyNCT07595861
Recovery Trajectories After Total Knee Arthroplasty
An observational study of Total Knee Anthroplasty and Patient Reported Outcome Measurements, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This prospective cohort study aimed to compare recovery trajectories following cruciate-retaining (CR) and posterior-stabilized (PS) total knee arthroplasty (TKA) using rehabilitation-centered patient-reported outcome measures (PROMs). Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Anthroplasty, Patient Reported Outcome Measurements, Cruciate Ligament Reconstruction
- What is being tested?
- Cruciate-Retaining Total Knee Arthroplasty and Posterior-Stabilized Total Knee Arthroplasty
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Jul 2025
- Phase
- Observational
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of patients aged between 50 years and 65 years who were scheduled to undergo primary unilateral total knee arthroplasty at a single orthopedic center. All participants were Turkish-speaking, fully oriented, and capable of completing patient-reported outcome measures. The cohort included individuals who received surgery under standardized perioperative and postoperative care protocols. Patients with revision arthroplasty, neurological or neuromuscular disorders affecting gait, cognitive impairment, psychiatric disease, or major perioperative complications were not included in the study population.
Who may be able to join
- Patients scheduled for primary unilateral total knee arthroplasty (TKA).
- Ability to read and understand Turkish.
- Full orientation in person, place, and time.
- Voluntary participation with informed consent.
- Surgery performed at the same institution under standardized perioperative and postoperative care protocols.
Who cannot join
- Revision total knee arthroplasty.
- Presence of neuromuscular or neurological disorders affecting gait (e.g., stroke, Parkinson disease, myopathies).
- Cognitive impairment or diagnosed psychiatric disorders that may interfere with questionnaire completion or participation.
- Perioperative complications such as excessive bleeding, infection, prosthesis dislocation, or deep venous thrombosis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55270
About this study
Official title: Recovery Trajectories After Cruciate Retaining And Posterior Stabilized Total Knee Arthroplasty
This prospective cohort study aimed to compare recovery trajectories following cruciate-retaining (CR) and posterior-stabilized (PS) total knee arthroplasty (TKA) using rehabilitation-centered patient-reported outcome measures (PROMs). Forty patients undergoing primary unilateral TKA were evaluated preoperatively and at 3 and 6 months postoperatively. Outcomes included pain intensity, functional status, kinesiophobia, health-related quality of life, and joint awareness assessed using validated PROMs including the Visual Analog Scale (VAS), WOMAC, Tampa Scale for Kinesiophobia (TSK), SF-36, and Forgotten Joint Score-12 (FJS-12). The study investigated whether posterior cruciate ligament management influences early postoperative recovery trajectories after TKA.
Read the detailed description
Total knee arthroplasty (TKA) is an effective surgical intervention for patients with advanced knee osteoarthritis who experience persistent pain and functional limitations despite conservative treatment. Among contemporary implant designs, cruciate-retaining (CR) and posterior-stabilized (PS) prostheses are the most widely used approaches. CR implants preserve the posterior cruciate ligament (PCL) to maintain more physiological knee kinematics, whereas PS implants substitute PCL function through a post-cam mechanism. Although both designs have demonstrated successful clinical outcomes, evidence regarding their comparative influence on postoperative recovery remains inconclusive.
In recent years, postoperative evaluation after TKA has increasingly emphasized rehabilitation-centered patient-reported outcome measures (PROMs) rather than solely clinician-based assessments. Parameters such as pain, functional status, quality of life, kinesiophobia, and joint awareness provide a more comprehensive understanding of patient recovery and adaptation after surgery. However, studies directly comparing CR and PS TKA from this multidimensional rehabilitation perspective remain limited.
This single-center prospective cohort study was conducted at the Department of Orthopedics and Traumatology, Ondokuz Mayıs University Health Application and Research Center. Patients aged 50 years or older undergoing primary unilateral TKA were included. Participants were allocated to CR or PS groups according to intraoperative surgical decision-making based on posterior cruciate ligament integrity, soft-tissue balance, and routine surgical practice. Standardized perioperative management and postoperative rehabilitation protocols were applied to all participants.
Pain intensity was assessed using the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), kinesiophobia with the Tampa Scale for Kinesiophobia (TSK), and health-related quality of life with the Short Form-36 Health Survey (SF-36). Joint awareness was evaluated postoperatively using the Forgotten Joint Score-12 (FJS-12). Assessments were performed preoperatively and repeated at 3 and 6 months after surgery.
The primary objective of the study was to compare longitudinal recovery trajectories between CR and PS TKA designs across rehabilitation-related PROMs. The study further aimed to determine whether posterior cruciate ligament management influences pain reduction, functional recovery, psychosocial adaptation, and joint awareness during the early postoperative period.
- Conditions
- Total Knee Anthroplasty, Patient Reported Outcome Measurements, Cruciate Ligament Reconstruction
- Being tested
- Cruciate-Retaining Total Knee Arthroplasty, Posterior-Stabilized Total Knee Arthroplasty
- Keywords
- total knee arthroplasty, patient-reported outcome measures, forgotten joint score, cruciate-retaining, posterior-stabilized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cruciate-Retaining Total Knee ArthroplastyOther
Primary unilateral total knee arthroplasty performed using a cruciate-retaining implant design in which the posterior cruciate ligament (PCL) was preserved. Implant selection was based on intraoperative assessment of ligament integrity and soft-tissue balance. Standardized perioperative management and postoperative rehabilitation protocols were applied to all participants.
Posterior-Stabilized Total Knee ArthroplastyOther
Primary unilateral total knee arthroplasty performed using a posterior-stabilized implant design incorporating a post-cam mechanism to substitute posterior cruciate ligament (PCL) function. Implant selection was determined intraoperatively according to ligament condition and soft-tissue balancing requirements. All participants received standardized perioperative care and postoperative rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Posterior-stabilized Group | Participants in the posterior-stabilized (PS) group underwent primary unilateral total knee arthroplasty using a posterior cruciate ligament-substituting implant design with a post-cam stabilization mechanism. Implant selection was determined intraoperatively according to posterior cruciate ligament condition, soft-tissue balancing requirements, and standard surgical practice. All participants received standardized perioperative care and postoperative rehabilitation. Recovery trajectories were assessed using validated patient-reported outcome measures evaluating pain, function, kinesiophobia, quality of life, and joint awareness before surgery and at 3 and 6 months postoperatively. Receives: Other: Posterior-Stabilized Total Knee Arthroplasty | |
| Cruciate-Retaining Group | Participants in the cruciate-retaining (CR) group underwent primary unilateral total knee arthroplasty using a posterior cruciate ligament-preserving implant design. Implant selection was determined intraoperatively based on posterior cruciate ligament integrity, soft-tissue balance, and routine surgical assessment. Patients received standardized perioperative management and postoperative rehabilitation protocols. Recovery outcomes were evaluated using patient-reported outcome measures including pain intensity, functional status, kinesiophobia, health-related quality of life, and joint awareness at preoperative, 3-month, and 6-month follow-up assessments. Receives: Other: Cruciate-Retaining Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Assessed by Visual Analog Scale (VAS)
The primary outcome measure is pain intensity evaluated using the 10-cm Visual Analog Scale (VAS). Patients indicate their perceived pain level on a continuous scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity. The VAS is a widely validated patient-reported outcome measure used to quantify subjective pain intensity in musculoskeletal and postoperative populations.
Measured: Baseline
Functional Status Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Functional status is evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which assesses pain, stiffness, and physical function. The questionnaire consists of multiple items scored on a Likert scale. Higher total and subscale scores indicate worse symptoms and greater functional impairment. WOMAC is a validated disease-specific outcome measure commonly used in lower extremity musculoskeletal conditions.
Measured: Baseline
Fear of Movement Assessed by Tampa Scale for Kinesiophobia (TSK)
Fear of movement and (re)injury is measured using the Tampa Scale for Kinesiophobia (TSK). The scale evaluates fear-related beliefs about physical activity and movement. It consists of multiple items rated on a Likert scale, with higher total scores indicating greater levels of kinesiophobia. The TSK is a validated tool widely used in musculoskeletal and postoperative rehabilitation populations.
Measured: Baseline
Health-Related Quality of Life Assessed by Short Form-36 (SF-36)
Health-related quality of life is assessed using the Short Form-36 (SF-36) questionnaire, which includes eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better perceived health status. SF-36 is a generic, validated quality-of-life instrument.
Measured: Baseline
Postoperative Joint Awareness Assessed by Forgotten Joint Score-12 (FJS-12)
Postoperative joint awareness is evaluated using the Forgotten Joint Score-12 (FJS-12), a joint-specific patient-reported outcome measure designed to assess the ability of patients to "forget" the presence of an artificial or affected joint during daily activities. The score is transformed to a 0-100 scale, where higher scores indicate lower joint awareness and better functional integration of the joint in daily life. The FJS-12 has a low ceiling effect and high sensitivity in detecting subtle differences in joint perception.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Apr 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee AnthroplastyStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MİNE PEKESEN KURTÇA, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595861
- Sponsor's protocol ID
- OMU2025/182
- Status last verified
- Feb 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Trajectories After Cruciate Retaining And Posterior Stabilized Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07595861
- Acronym / sponsor ID
- OMU2025/182
- Conditions
- Total Knee Anthroplasty, Patient Reported Outcome Measurements, Cruciate Ligament Reconstruction
- Keywords
- total knee arthroplasty, patient-reported outcome measures, forgotten joint score, cruciate-retaining, posterior-stabilized
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 19 May 2026 (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.
This prospective cohort study aimed to compare recovery trajectories following cruciate-retaining (CR) and posterior-stabilized (PS) total knee arthroplasty (TKA) using rehabilitation-centered patient-reported outcome measures (PROMs). Forty patients undergoing primary unilateral TKA were evaluated preoperatively and at 3 and 6 months postoperatively. Outcomes included pain intensity, functional status, kinesiophobia, health-related quality of life, and joint awareness assessed using validated PROMs including the Visual Analog Scale (VAS), WOMAC, Tampa Scale for Kinesiophobia (TSK), SF-36, and Forgotten Joint Score-12 (FJS-12). The study investigated whether posterior cruciate ligament management influences early postoperative recovery trajectories after TKA.
Detailed description
Total knee arthroplasty (TKA) is an effective surgical intervention for patients with advanced knee osteoarthritis who experience persistent pain and functional limitations despite conservative treatment. Among contemporary implant designs, cruciate-retaining (CR) and posterior-stabilized (PS) prostheses are the most widely used approaches. CR implants preserve the posterior cruciate ligament (PCL) to maintain more physiological knee kinematics, whereas PS implants substitute PCL function through a post-cam mechanism. Although both designs have demonstrated successful clinical outcomes, evidence regarding their comparative influence on postoperative recovery remains inconclusive.
In recent years, postoperative evaluation after TKA has increasingly emphasized rehabilitation-centered patient-reported outcome measures (PROMs) rather than solely clinician-based assessments. Parameters such as pain, functional status, quality of life, kinesiophobia, and joint awareness provide a more comprehensive understanding of patient recovery and adaptation after surgery. However, studies directly comparing CR and PS TKA from this multidimensional rehabilitation perspective remain limited.
This single-center prospective cohort study was conducted at the Department of Orthopedics and Traumatology, Ondokuz Mayıs University Health Application and Research Center. Patients aged 50 years or older undergoing primary unilateral TKA were included. Participants were allocated to CR or PS groups according to intraoperative surgical decision-making based on posterior cruciate ligament integrity, soft-tissue balance, and routine surgical practice. Standardized perioperative management and postoperative rehabilitation protocols were applied to all participants.
Pain intensity was assessed using the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), kinesiophobia with the Tampa Scale for Kinesiophobia (TSK), and health-related quality of life with the Short Form-36 Health Survey (SF-36). Joint awareness was evaluated postoperatively using the Forgotten Joint Score-12 (FJS-12). Assessments were performed preoperatively and repeated at 3 and 6 months after surgery.
The primary objective of the study was to compare longitudinal recovery trajectories between CR and PS TKA designs across rehabilitation-related PROMs. The study further aimed to determine whether posterior cruciate ligament management influences pain reduction, functional recovery, psychosocial adaptation, and joint awareness during the early postoperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior-stabilized Group | – | Other: Posterior-Stabilized Total Knee ArthroplastyParticipants in the posterior-stabilized (PS) group underwent primary unilateral total knee arthroplasty using a posterior cruciate ligament-substituting implant design with a post-cam stabilization mechanism. Implant selection was determined intraoperatively according to posterior cruciate ligament condition, soft-tissue balancing requirements, and standard surgical practice. All participants received standardized perioperative care and postoperative rehabilitation. Recovery trajectories were assessed using validated patient-reported outcome measures evaluating pain, function, kinesiophobia, quality of life, and joint awareness before surgery and at 3 and 6 months postoperatively. |
| Cruciate-Retaining Group | – | Other: Cruciate-Retaining Total Knee ArthroplastyParticipants in the cruciate-retaining (CR) group underwent primary unilateral total knee arthroplasty using a posterior cruciate ligament-preserving implant design. Implant selection was determined intraoperatively based on posterior cruciate ligament integrity, soft-tissue balance, and routine surgical assessment. Patients received standardized perioperative management and postoperative rehabilitation protocols. Recovery outcomes were evaluated using patient-reported outcome measures including pain intensity, functional status, kinesiophobia, health-related quality of life, and joint awareness at preoperative, 3-month, and 6-month follow-up assessments. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients aged between 50 years and 65 years who were scheduled to undergo primary unilateral total knee arthroplasty at a single orthopedic center. All participants were Turkish-speaking, fully oriented, and capable of completing patient-reported outcome measures. The cohort included individuals who received surgery under standardized perioperative and postoperative care protocols. Patients with revision arthroplasty, neurological or neuromuscular disorders affecting gait, cognitive impairment, psychiatric disease, or major perioperative complications were not included in the study population.
Key inclusion criteria (5 listed)
- Patients scheduled for primary unilateral total knee arthroplasty (TKA).
- Ability to read and understand Turkish.
- Full orientation in person, place, and time.
- Voluntary participation with informed consent.
- Surgery performed at the same institution under standardized perioperative and postoperative care protocols.
Key exclusion criteria (4 listed)
- Revision total knee arthroplasty.
- Presence of neuromuscular or neurological disorders affecting gait (e.g., stroke, Parkinson disease, myopathies).
- Cognitive impairment or diagnosed psychiatric disorders that may interfere with questionnaire completion or participation.
- Perioperative complications such as excessive bleeding, infection, prosthesis dislocation, or deep venous thrombosis.
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 |
|---|---|---|
| Cruciate-Retaining Total Knee ArthroplastyPrimary unilateral total knee arthroplasty performed using a cruciate-retaining implant design in which the posterior cruciate ligament (PCL) was preserved. Implant selection was based on intraoperative assessment of ligament integrity and soft-tissue balance. Standardized perioperative management and postoperative rehabilitation protocols were applied to all participants. | Other | Cruciate-Retaining Group |
| Posterior-Stabilized Total Knee ArthroplastyPrimary unilateral total knee arthroplasty performed using a posterior-stabilized implant design incorporating a post-cam mechanism to substitute posterior cruciate ligament (PCL) function. Implant selection was determined intraoperatively according to ligament condition and soft-tissue balancing requirements. All participants received standardized perioperative care and postoperative rehabilitation. | Other | Posterior-stabilized Group |
Primary outcome
Change in Pain Intensity Assessed by Visual Analog Scale (VAS)
Time frame: Baseline
The primary outcome measure is pain intensity evaluated using the 10-cm Visual Analog Scale (VAS). Patients indicate their perceived pain level on a continuous scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity. The VAS is a widely validated patient-reported outcome measure used to quantify subjective pain intensity in musculoskeletal and postoperative populations.
Functional Status Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline
Functional status is evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which assesses pain, stiffness, and physical function. The questionnaire consists of multiple items scored on a Likert scale. Higher total and subscale scores indicate worse symptoms and greater functional impairment. WOMAC is a validated disease-specific outcome measure commonly used in lower extremity musculoskeletal conditions.
Fear of Movement Assessed by Tampa Scale for Kinesiophobia (TSK)
Time frame: Baseline
Fear of movement and (re)injury is measured using the Tampa Scale for Kinesiophobia (TSK). The scale evaluates fear-related beliefs about physical activity and movement. It consists of multiple items rated on a Likert scale, with higher total scores indicating greater levels of kinesiophobia. The TSK is a validated tool widely used in musculoskeletal and postoperative rehabilitation populations.
Health-Related Quality of Life Assessed by Short Form-36 (SF-36)
Time frame: Baseline
Health-related quality of life is assessed using the Short Form-36 (SF-36) questionnaire, which includes eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better perceived health status. SF-36 is a generic, validated quality-of-life instrument.
Postoperative Joint Awareness Assessed by Forgotten Joint Score-12 (FJS-12)
Time frame: Baseline
Postoperative joint awareness is evaluated using the Forgotten Joint Score-12 (FJS-12), a joint-specific patient-reported outcome measure designed to assess the ability of patients to "forget" the presence of an artificial or affected joint during daily activities. The score is transformed to a 0-100 scale, where higher scores indicate lower joint awareness and better functional integration of the joint in daily life. The FJS-12 has a low ceiling effect and high sensitivity in detecting subtle differences in joint perception.
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 19 May 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Total Knee Anthroplasty and Patient Reported Outcome Measurements, run by Ondokuz Mayıs 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 5 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 19 May 2026. 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?
Change in Pain Intensity Assessed by Visual Analog Scale (VAS) (time frame: Baseline). The study lists 5 primary outcomes in all. 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 19 May 2026.