Meniscal TearMEN-KINNCT07654894
Effect of Preoperative Kinesiophobia on Clinical Outcomes Following Arthroscopic Meniscus Surgery
An observational study of Meniscal Tear, run by Medipol University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meniscal Tear
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Preoperative Kinesiophobia on Clinical Success in Patients Undergoing Arthroscopic Surgery for Meniscal Tears
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.
Read the detailed description
Meniscal tears are among the most common knee injuries encountered in orthopedic practice and represent a major cause of knee pain, mechanical symptoms, and functional impairment. Although conservative treatment may be effective in selected patients, arthroscopic surgery remains a widely performed procedure for individuals with persistent symptoms or mechanical dysfunction. Despite advances in surgical techniques and standardized rehabilitation protocols, postoperative recovery varies considerably among patients with similar structural pathology, suggesting that factors beyond the anatomical lesion may influence clinical outcomes.
Psychological factors have increasingly been recognized as important determinants of recovery after musculoskeletal injuries and orthopedic surgery. Among these, kinesiophobia, defined as an excessive and debilitating fear of movement resulting from pain or the anticipation of reinjury, may negatively affect rehabilitation adherence, physical activity, muscle performance, and overall functional recovery. Patients with high levels of kinesiophobia may avoid movement, resulting in delayed restoration of knee function and persistent disability. However, evidence specifically evaluating the influence of preoperative kinesiophobia on outcomes following arthroscopic meniscal surgery remains limited.
The present study is designed as a prospective, single-center, observational cohort study to investigate the effect of preoperative kinesiophobia on postoperative clinical success in patients undergoing arthroscopic surgery for meniscal tears. Adult patients aged 18 to 65 years with a diagnosis of a meniscal tear confirmed by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic surgery will be consecutively enrolled.
Baseline assessments will include demographic characteristics, body mass index, symptom duration, affected side, meniscal tear localization, and the type of arthroscopic procedure performed. Pain intensity will be evaluated using the Visual Analog Scale (VAS), functional status will be assessed using the Lysholm Knee Score, and fear of movement will be measured using the Tampa Scale for Kinesiophobia (TSK). All outcome measures will be recorded preoperatively and at the postoperative third month, providing a standardized assessment of changes in pain, function, and kinesiophobia over the early recovery period.
Participants will be categorized according to their preoperative kinesiophobia levels, and postoperative clinical outcomes will be compared between groups. In addition, correlation analyses will be performed to determine the relationship between preoperative kinesiophobia and postoperative pain and functional recovery. Appropriate statistical methods will be used to evaluate between-group differences and associations, with statistical significance defined as p < 0.05.
The findings of this study are expected to clarify the role of preoperative kinesiophobia as a potential predictor of postoperative clinical success following arthroscopic meniscal surgery. Improved understanding of this relationship may facilitate the identification of patients at risk for suboptimal recovery and support the development of individualized perioperative rehabilitation strategies that incorporate both physical and psychological components.
- Conditions
- Meniscal Tear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and postoperative 3 months
Secondary outcomes (2)
Change in Visual Analog Scale (VAS) Pain Score
Assessment of postoperative pain intensity using the 10-cm Visual Analog Scale (VAS). Lower scores indicate less pain.
Measured: Baseline (preoperative) and postoperative 3 months.
Change in Tampa Scale for Kinesiophobia (TSK) Score
Assessment of fear of movement using the Tampa Scale for Kinesiophobia. Higher scores indicate greater kinesiophobia.
Measured: Baseline (preoperative) and postoperative 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start25 Jun 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal TearStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdal Güngör, Medipol University
- Investigators
- Erdal Güngör, M.D, Principal investigator, Istanbul Medipol University, Department of Orthopedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654894
- Sponsor's protocol ID
- MBH-ORTHO-2026-001
- Acronym
- MEN-KIN
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Kinesiophobia on Clinical Success in Patients Undergoing Arthroscopic Surgery for Meniscal Tears
- ClinicalTrials.gov ID
- NCT07654894
- Acronym / sponsor ID
- MEN-KIN / MBH-ORTHO-2026-001
- Conditions
- Meniscal Tear
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Jun 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.
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.
Detailed description
Meniscal tears are among the most common knee injuries encountered in orthopedic practice and represent a major cause of knee pain, mechanical symptoms, and functional impairment. Although conservative treatment may be effective in selected patients, arthroscopic surgery remains a widely performed procedure for individuals with persistent symptoms or mechanical dysfunction. Despite advances in surgical techniques and standardized rehabilitation protocols, postoperative recovery varies considerably among patients with similar structural pathology, suggesting that factors beyond the anatomical lesion may influence clinical outcomes.
Psychological factors have increasingly been recognized as important determinants of recovery after musculoskeletal injuries and orthopedic surgery. Among these, kinesiophobia, defined as an excessive and debilitating fear of movement resulting from pain or the anticipation of reinjury, may negatively affect rehabilitation adherence, physical activity, muscle performance, and overall functional recovery. Patients with high levels of kinesiophobia may avoid movement, resulting in delayed restoration of knee function and persistent disability. However, evidence specifically evaluating the influence of preoperative kinesiophobia on outcomes following arthroscopic meniscal surgery remains limited.
The present study is designed as a prospective, single-center, observational cohort study to investigate the effect of preoperative kinesiophobia on postoperative clinical success in patients undergoing arthroscopic surgery for meniscal tears. Adult patients aged 18 to 65 years with a diagnosis of a meniscal tear confirmed by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic surgery will be consecutively enrolled.
Baseline assessments will include demographic characteristics, body mass index, symptom duration, affected side, meniscal tear localization, and the type of arthroscopic procedure performed. Pain intensity will be evaluated using the Visual Analog Scale (VAS), functional status will be assessed using the Lysholm Knee Score, and fear of movement will be measured using the Tampa Scale for Kinesiophobia (TSK). All outcome measures will be recorded preoperatively and at the postoperative third month, providing a standardized assessment of changes in pain, function, and kinesiophobia over the early recovery period.
Participants will be categorized according to their preoperative kinesiophobia levels, and postoperative clinical outcomes will be compared between groups. In addition, correlation analyses will be performed to determine the relationship between preoperative kinesiophobia and postoperative pain and functional recovery. Appropriate statistical methods will be used to evaluate between-group differences and associations, with statistical significance defined as p < 0.05.
The findings of this study are expected to clarify the role of preoperative kinesiophobia as a potential predictor of postoperative clinical success following arthroscopic meniscal surgery. Improved understanding of this relationship may facilitate the identification of patients at risk for suboptimal recovery and support the development of individualized perioperative rehabilitation strategies that incorporate both physical and psychological components.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Lysholm Knee Score
Time frame: Baseline and postoperative 3 months
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.
2 secondary outcomes
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Baseline (preoperative) and postoperative 3 months.
Change in Tampa Scale for Kinesiophobia (TSK) Score
Time frame: Baseline (preoperative) and postoperative 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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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.
Erdal Güngör, M.D principal investigator
Istanbul Medipol University, Department of Orthopedics and Traumatology
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscal Tear, run by Medipol University.
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 3 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erdal Güngör, M.D (+90 543 879 0630, egungor_49@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lysholm Knee Score (time frame: Baseline and postoperative 3 months). 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 17 Jun 2026.