NCT05721547

Brief Summary

The aim of this observational study was to the alterations in spinal alignment in individuals who have undergone RC surgery and revealed the differences compared to healthy individuals.

Trial Health

87
On Track

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
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

February 1, 2023

Last Update Submit

February 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Spinal alignment and mobility assessment

    The Spinal Mouse (IDIAG M360), novel, a computer-aided electronic measuring tool that noninvasively evaluates spinal range of motion and intersegmental angles, was used to examine spinal posture. The Spinal Mouse device is reliable and valid for the assessment of spine mobility and posture

    8 months

Secondary Outcomes (3)

  • Scapular dyskinesia

    8 months

  • Range of Motion

    8 months

  • Postural stability

    8 months

Study Arms (2)

RC Repair Group

Participants who had undergone the same arthroscopic RM surgical procedure and technique; had undergone acromioplasty and/or tenodesis with RM repair; had undergone arthroscopic RM surgery from the upper extremity of the dominant side; had completed six months following surgery

Other: Assessment

Healthy Group

Participants who had not undergone any shoulder surgery, had no history of shoulder-related pain, discomfort, or trauma in the last year

Other: Assessment

Interventions

Assessment

Healthy GroupRC Repair Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent arthroscopic RM surgery who had undergone the same arthroscopic RM surgical procedure and technique

You may qualify if:

  • those who had undergone the same arthroscopic RM surgical procedure and technique
  • had undergone acromioplasty and/or tenodesis with RM repair
  • had undergone arthroscopic RM surgery from the upper extremity of the dominant side;
  • had completed six months following surgery; were able to perform active shoulder elevation movements of 90° or more
  • were between the ages of 40 and 75
  • were volunteers to participate in the study.

You may not qualify if:

  • who had undergone previous shoulder surgery or revision surgery, subscapularis tendon repair in addition to RM repair, scoliosis surgery, or any surgeries to limit spine motion, as well as those with a history of upper extremity fractures, diabetes mellitus, hypertension, cardiovascular disease, or chronic respiratory diseases that could limit the test's ability to be accomplished

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Central, 14000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesSpinal Curvatures

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

June 20, 2018

Primary Completion

May 25, 2019

Study Completion

January 15, 2020

Last Updated

February 10, 2023

Record last verified: 2023-02

Locations