NCT07654894

Brief Summary

Meniscal tears are among the most common knee injuries and frequently require arthroscopic surgical treatment when conservative management fails or mechanical symptoms persist. Although surgical techniques have improved clinical outcomes, postoperative recovery is influenced not only by structural pathology but also by psychological factors. Kinesiophobia, defined as an excessive and debilitating fear of movement due to pain or the expectation of reinjury, may negatively affect rehabilitation adherence, functional recovery, and pain perception. This prospective observational study aims to investigate the effect of preoperative kinesiophobia on postoperative clinical outcomes in patients undergoing arthroscopic surgery for meniscal tears. Adult patients diagnosed with a meniscal tear by clinical examination and magnetic resonance imaging and scheduled for arthroscopic surgery will be enrolled. Preoperative demographic and clinical characteristics, pain intensity, functional status, and kinesiophobia levels will be assessed using validated outcome measures. Postoperative evaluations will be performed three months after surgery to determine changes in pain and functional outcomes. The relationship between preoperative kinesiophobia and postoperative clinical success will be analyzed. The findings of this study may help identify patients at risk for suboptimal recovery and support the development of individualized rehabilitation strategies.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Jun 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

June 25, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Lysholm Knee Score

    To evaluate the change in knee function using the Lysholm Knee Score from baseline (preoperative assessment) to the postoperative 3-month follow-up in patients undergoing arthroscopic surgery for meniscal tears.

    Baseline and postoperative 3 months

Secondary Outcomes (2)

  • Change in Visual Analog Scale (VAS) Pain Score

    Baseline (preoperative) and postoperative 3 months.

  • Change in Tampa Scale for Kinesiophobia (TSK) Score

    Baseline (preoperative) and postoperative 3 months.

Study Arms (2)

High Kinesiophobia Group

Patients with meniscal tears scheduled for arthroscopic surgery who demonstrate high preoperative kinesiophobia based on the Tampa Scale for Kinesiophobia (TSK). Participants will undergo standard surgical treatment and routine postoperative rehabilitation and will be evaluated preoperatively and at the postoperative third month for pain and functional outcomes.

Low Kinesiophobia Group

Patients with meniscal tears scheduled for arthroscopic surgery who demonstrate low preoperative kinesiophobia based on the Tampa Scale for Kinesiophobia (TSK). Participants will undergo the same standard surgical treatment and routine postoperative rehabilitation and will be evaluated preoperatively and at the postoperative third month for pain and functional outcomes.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult patients aged 18-65 years who are diagnosed with a meniscal tear by clinical examination and magnetic resonance imaging (MRI) and are scheduled to undergo arthroscopic meniscal surgery at the Department of Orthopedics and Traumatology of a single tertiary care center. Eligible participants who provide written informed consent and meet the inclusion criteria will be enrolled consecutively. Preoperative and postoperative clinical assessments will be performed according to the study protocol.

You may qualify if:

  • Adults aged 18 to 65 years. Diagnosis of meniscal tear confirmed by clinical examination and magnetic resonance imaging (MRI).
  • Patients scheduled to undergo arthroscopic meniscal surgery. Ability to understand and complete the study questionnaires. Willingness to participate and provide written informed consent. Availability for both preoperative assessment and postoperative 3-month follow-up.

You may not qualify if:

  • Previous surgery on the affected knee. Concomitant anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), or collateral ligament injuries requiring surgical treatment.
  • Advanced knee osteoarthritis (e.g., Kellgren-Lawrence grade 3 or 4). History of inflammatory rheumatic disease or active joint infection. Neurological disorders affecting lower extremity function or balance. Severe psychiatric disorders or cognitive impairment preventing completion of questionnaires.
  • Pregnancy. Inability or unwillingness to provide written informed consent. Inability to attend the 3-month postoperative follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Erdal Güngör, M.D

    Istanbul Medipol University, Department of Orthopedics and Traumatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erdal Güngör, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Orthopaedics and Traumatology

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start (Estimated)

June 25, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06