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Completed

NCT Number: NCT07595861

Recovery Trajectories After 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.

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Key information

Conditions

Total Knee Anthroplasty Cruciate Ligament Reconstruction Patient Reported Outcome Measurements

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuz Mayis University

Samsun, Atakum, 55270, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cruciate-Retaining Total Knee Arthroplasty

Other

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 Arthroplasty

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Recovery Trajectories After Cruciate Retaining And Posterior Stabilized Total Knee Arthroplasty

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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