NCT07001566

Brief Summary

The aim of the study is to evaluate the impact of cervical radiculopathy on functional status and quality of life outcomes in patients who have undergone rotator cuff repair, comparing the group with a history of cervical radiculopathy to the group without cervical radiculopathy. Study topic: The participants of the study were selected from patients who underwent rotator cuff repair at the Orthopedics and Traumatology clinic of Kartal Dr. Lütfi Kırdar City Hospital between 2018 and 2023. The first group consisted of patients without cervical radiculopathy, while the second group included patients with a previously diagnosed cervical radiculopathy. The study will examine the effect of the presence of cervical radiculopathy on functional outcomes and quality of life in patients who underwent rotator cuff repair.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

March 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

May 14, 2025

Last Update Submit

June 1, 2025

Conditions

Keywords

painfunctionalityquality of life

Outcome Measures

Primary Outcomes (1)

  • Functionality and quality of life

    Between the years 2018 and 2023

Secondary Outcomes (1)

  • pain perception

    Between the years 2018 and 2023

Study Arms (2)

Patient's who has cervical radiculopathy

There will be only done assessment.

Other: There was no intervention. Only assessment procedure will be performed.

Patient's who has not cervical radiculopathy

There will be only done assessment.

Other: There was no intervention. Only assessment procedure will be performed.

Interventions

There was no intervention. Only assessment procedure will be performed.

Patient's who has cervical radiculopathyPatient's who has not cervical radiculopathy

Eligibility Criteria

Age41 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study was conducted on 50 patients who underwent rotator cuff surgery between 2018 and 2023, with a mean age of 53.74 ± 6.58 years, 54% of whom were female

You may qualify if:

  • Patients who have undergone rotator cuff repair
  • Patients under the age of 65

You may not qualify if:

  • Patients who have undergone shoulder surgery other than rotator cuff repair
  • Patients with a history of cervical spine surgery
  • Patients with any neurological disorders
  • Patients with a history of pathological fractures
  • Patients with oncological diseases
  • Patients with a history of infection
  • Patients who were deceased at the time of retrospective screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Lütfi Kırdar City Hospital

Istanbul, Istanbul, 34870, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Rotator Cuff InjuriesPain

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 14, 2025

First Posted

June 3, 2025

Study Start

March 20, 2025

Primary Completion

August 20, 2025

Study Completion

September 30, 2025

Last Updated

June 3, 2025

Record last verified: 2025-05

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