Chronic Instability of JointNCT02978365
Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability
A study testing Questionnaires and Isokinetic Strength Measurement in people with Chronic Instability of Joint, run by Uri Gottlieb at 1 site in Israel.
Trial summary
Case control study to evaluate different factors (e.g muscle strength, psychological factors) that are associated with full recovery and functional status 6 months after surgical repair of shoulder instability. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Chronic Instability of Joint
- What is being tested?
- Questionnaires and Isokinetic Strength Measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Mar 2017to 22 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 26-28 weeks s/p surgical repair of shoulder instability
- At least 1 shoulder dislocation prior to surgery
Who cannot join
- Previous surgery in either shoulders
- Any injury in the non-operated shoulder in the last 6 months
- Any history of shoulder dislocation or subluxation in the non-operated shoulder
- Any tendon repair during the surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability - Cross Sectional Study
Case control study to evaluate different factors (e.g muscle strength, psychological factors) that are associated with full recovery and functional status 6 months after surgical repair of shoulder instability.
Read the detailed description
In this study the investigators will try to find correlations between different factors and functional abilities of patients 6 months post shoulder surgery.
Patients will be examined in a single encounter for muscle strength, fear avoidance beliefs and functional abilities.
Functional abilities will be examined using two validated questionnaires:
- The Western Ontario Shoulder Instability index (WOSI)
- Disabilities of the Arm, Shoulder and Hand (DASH)
Fear avoidance will be evaluated using the Fear Avoidance Belief Questionnaire (FABQ)
Muscle strength of the rotator cuff muscles will be measured using Biodex Isokinetic system, model 4.
- Conditions
- Chronic Instability of Joint
- Being tested
- Questionnaires, Isokinetic Strength Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Patients will fill self-reported functional shoulder scales (1. Western Ontario Shoulder Instability index - WOSI, and 2. Disabilities of Arm, Shoulder and Hand questionnaire - DASH), as well as a Fear Avoidance Belief Questionnaire (FABQ).
Isokinetic Strength MeasurementDevice
Isokinetic strength will be measured using a Biodex Isokinetic System 4.0 (Shirley, NY)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Male patients who undergone shoulder surgery to repair chronic instability (at least 1 shoulder dislocation prior to surgery). Time since surgery will be between 26 and 28 weeks. Patients will go through filling questionnaires and isokinetic strength measurements. Receives: Other: Questionnaires; Device: Isokinetic Strength Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Shoulder Instability index (WOSI)
Functional scale
Measured: 26-28 weeks post surgery
Secondary outcomes (3)
Fear avoidance belief questionnaire (FABQ)
Fear avoidance questionnaire
Measured: 26-28 weeks post surgery
Isokinetic strength
Ratios between Internal and External rotation strength in both shoulders
Measured: 26-28 weeks post surgery
Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)
Functional scale
Measured: 26-28 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start16 Mar 2017
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Instability of JointStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uri Gottlieb
- Sponsor type
- University, hospital or other
- Collaborators
- Wolfson Medical Center
- Responsible party
- Sponsor-investigator, Uri Gottlieb, Medical Corps, Israel Defense Force
- Investigators
- Arnon Gam, M.D, Principal investigator, Medical Corp, Israel Defense Forces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978365
- Sponsor's protocol ID
- IDF-1702-2016
- Other IDs
- 0177-16-WOMC
- Status last verified
- Jun 2018
- First submitted
- 21 Nov 2016
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be published after statistical analysis only.
Publications
Gottlieb U, Springer S. Translation and validation of a Hebrew version of the Western Ontario Shoulder Instability index. J Orthop Surg Res. 2019 Aug 1;14(1):245. doi: 10.1186/s13018-019-1289-4.
PubMed 31370869
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability - Cross Sectional Study
- ClinicalTrials.gov ID
- NCT02978365
- Acronym / sponsor ID
- IDF-1702-2016
- Conditions
- Chronic Instability of Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Uri GottliebUniversity, hospital or other
- Collaborators
- Wolfson Medical Center
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 30 Nov 2016 (estimated)
- 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.
Case control study to evaluate different factors (e.g muscle strength, psychological factors) that are associated with full recovery and functional status 6 months after surgical repair of shoulder instability.
Detailed description
In this study the investigators will try to find correlations between different factors and functional abilities of patients 6 months post shoulder surgery.
Patients will be examined in a single encounter for muscle strength, fear avoidance beliefs and functional abilities.
Functional abilities will be examined using two validated questionnaires:
- The Western Ontario Shoulder Instability index (WOSI)
- Disabilities of the Arm, Shoulder and Hand (DASH)
Fear avoidance will be evaluated using the Fear Avoidance Belief Questionnaire (FABQ)
Muscle strength of the rotator cuff muscles will be measured using Biodex Isokinetic system, model 4.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Questionnaires, Device: Isokinetic Strength MeasurementMale patients who undergone shoulder surgery to repair chronic instability (at least 1 shoulder dislocation prior to surgery). Time since surgery will be between 26 and 28 weeks. Patients will go through filling questionnaires and isokinetic strength measurements. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 26-28 weeks s/p surgical repair of shoulder instability
- At least 1 shoulder dislocation prior to surgery
Key exclusion criteria (4 listed)
- Previous surgery in either shoulders
- Any injury in the non-operated shoulder in the last 6 months
- Any history of shoulder dislocation or subluxation in the non-operated shoulder
- Any tendon repair during the surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesPatients will fill self-reported functional shoulder scales (1. Western Ontario Shoulder Instability index - WOSI, and 2. Disabilities of Arm, Shoulder and Hand questionnaire - DASH), as well as a Fear Avoidance Belief Questionnaire (FABQ). | Other | Patients |
| Isokinetic Strength MeasurementIsokinetic strength will be measured using a Biodex Isokinetic System 4.0 (Shirley, NY) | Device | Patients |
Primary outcome
Western Ontario Shoulder Instability index (WOSI)
Time frame: 26-28 weeks post surgery
Functional scale
3 secondary outcomes
Fear avoidance belief questionnaire (FABQ)
Time frame: 26-28 weeks post surgery
Isokinetic strength
Time frame: 26-28 weeks post surgery
Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: 26-28 weeks post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Derived from this study: PubMed 31370869Gottlieb U, Springer S. Translation and validation of a Hebrew version of the Western Ontario Shoulder Instability index. J Orthop Surg Res. 2019 Aug 1;14(1):245. doi: 10.1186/s13018-019-1289-4.
- Individual participant dataSharing planned: No. Data will be published after statistical analysis only.
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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. This study is not recruiting at the moment.
Arnon Gam, M.D principal investigator
Medical Corp, Israel Defense Forces
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires and Isokinetic Strength Measurement in people with Chronic Instability of Joint, run by Uri Gottlieb at 1 site in Israel.
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 4 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: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Shoulder Instability index (WOSI) (time frame: 26-28 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02978365, which also lists 1 linked publication.
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 8 Jun 2018.