- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07595861
Recovery Trajectories After Total Knee Arthroplasty
Recovery Trajectories After Cruciate Retaining And Posterior Stabilized Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Atakum
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Samsun, Atakum, Turkey (Türkiye), 55270
- Ondokuz Mayis University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline
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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.
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Baseline
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Fear of Movement Assessed by Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline
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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.
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Baseline
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Health-Related Quality of Life Assessed by Short Form-36 (SF-36)
Time Frame: Baseline
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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.
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Baseline
|
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OMU2025/182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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