NCT06920654

Brief Summary

This retrospective cohort study aims to evaluate the clinical outcomes of patients who underwent arthroscopic shoulder stabilization using a bone block technique for chronic recurrent shoulder dislocations. The study will assess complications, reoperations, and functional outcomes measured by the Western Ontario Shoulder Instability (WOSI) score. Patients operated on within the past 1-8 years will be included. Data will be collected through structured telephone interviews and medical record reviews.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress63%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

March 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

March 26, 2025

Last Update Submit

May 22, 2025

Conditions

Keywords

shoulder instabilityrecurrenceLatarjetarthroscopybone block

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Recurrence of shoulder instability (measured through patient-reported dislocation episodes).

    From the index surgery to the time of the telephone interview, which may be up to 10 years.

Secondary Outcomes (3)

  • Postoperative complications

    From the index surgery to the time of the telephone interview, which may be up to 10 years.

  • WOSI score

    At the time of the telephone interview, which may be up to 10 years after the index surgery.

  • HRQoL

    At the time of the telephone interview, which may be up to 10 years after the index surgery.

Eligibility Criteria

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

The study population consists of patients who underwent arthroscopic shoulder stabilization with a bone block technique at a single orthopedic center. Approximately 40-50 patients are expected to be included, with a retrospective follow-up period of 1-10 years postoperatively.

You may qualify if:

  • Patients who underwent surgery for chronic recurrent shoulder dislocations.
  • Patients aged 18 years or older who provide informed consent.

You may not qualify if:

  • Patients with other concurrent shoulder surgeries unrelated to bone block stabilization.
  • Patients with major orthopedic conditions affecting the study outcome.
  • Patients with insufficient follow-up data.
  • Patients who do not provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drammen Hospital

Drammen, 3004, Norway

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Per Reidar Høiness, MD Phd

    Vestre Viken HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 10, 2025

Study Start

April 1, 2025

Primary Completion

June 30, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations