Rotator Cuff InjuryRCRNCT03885856
Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair
An observational study of Rotator Cuff Injury, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to analyse whether there is a difference in clinical and radiological outcomes between single row and double row repair techniques for the treatment of shoulder's rotator cuff tears. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- single row repair technique and double row repair technique
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Apr 2019to 22 Jul 2019
- Phase
- Observational
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated for rotator cuff lesion either traumatic or degenerative at the University Hospital Basel and Kantonsspital BaselLand between 01.01.2015 and 30.1.2018
Who may be able to join
- Treated by single row or double row repair technique for shoulder's rotator cuff tears
- Time lapse from injury to surgery ranges from one day to less than 1 year
- Availability of clinical and radiological outcomes from 6 months to 1 year follow up
Who cannot join
- Massive irreparable tear
- Patient has frozen shoulder
- Chronically retracted tendons and atrophic rotator cuff muscles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair; a Comparative Study
This study is to analyse whether there is a difference in clinical and radiological outcomes between single row and double row repair techniques for the treatment of shoulder's rotator cuff tears.
Read the detailed description
A tear of the rotator cuff is one of the most common disorders of the shoulder and can have a significant effect on daily activities as a result of a loss of motion and strength. The goal of rotator cuff repair is to treat the patient's current clinical symptoms and improve shoulder function and to prevent the long-term consequences of rotator cuff arthropathy. This project aims at a retrospective analysis of preexisting risk factors for sustaining rotator cuff injury as well as for failing to reach the previous functional level, used surgical technique -either single row repair or double row repair- and its significance for the functional outcome.
- Conditions
- Rotator Cuff Injury
- Being tested
- single row repair technique, double row repair technique
- Keywords
- rotator cuff repair, rotator cuff tear, single row repair technique, double row repair technique
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single row repair techniqueOther
single row repair technique
double row repair techniqueOther
double row repair technique
| Study group | Role | What they receive |
|---|---|---|
| single row repair technique | patients surgically treated for rotator cuff lesion by single row repair technique Receives: Other: single row repair technique | |
| double row repair technique | patients surgically treated for rotator cuff lesion by double row repair technique Receives: Other: double row repair technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic assessment of surgical treatment of rotator cuff tear
X-ray shoulder for assessment of acromiohumeral space and morphology (Millimeters)
Measured: directly postoperative (within 24 hours after surgery)
Magnetic resonance imaging (MRI) of surgical treatment of rotator cuff tear
MRI shoulder to asses morphology of shoulder
Measured: directly postoperative (within 24 hours after surgery)
Ultrasonography of surgical treatment of rotator cuff tear
Ultrasonography to evaluate the healing of the tendon at the bone interface and degree of gap Formation (degree)
Measured: From 6 months up to 1 year postoperative
Secondary outcomes (4)
Active range of motion
Active range of motion of shoulder (degrees)
Measured: At six months and one year follow up after surgery
Passive range of motion
Passive range of motion of shoulder (degrees)
Measured: At six months and one year follow up after surgery
Use of analgesics
Use of analgesics (yes/no)
Measured: At six months after surgery
Use of analgesics
Use of analgesics (yes/no)
Measured: At one year follow up after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start3 Apr 2019
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohy Taha, Dr. med, Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885856
- Sponsor's protocol ID
- 2019-00339; ch19Taha
- Other IDs
- 2019
- Acronym
- RCR
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2019
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair; a Comparative Study
- ClinicalTrials.gov ID
- NCT03885856
- Acronym / sponsor ID
- RCR / 2019-00339; ch19Taha
- Conditions
- Rotator Cuff Injury
- Keywords
- rotator cuff repair, rotator cuff tear, single row repair technique, double row repair technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 22 Mar 2019 (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.
This study is to analyse whether there is a difference in clinical and radiological outcomes between single row and double row repair techniques for the treatment of shoulder's rotator cuff tears.
Detailed description
A tear of the rotator cuff is one of the most common disorders of the shoulder and can have a significant effect on daily activities as a result of a loss of motion and strength. The goal of rotator cuff repair is to treat the patient's current clinical symptoms and improve shoulder function and to prevent the long-term consequences of rotator cuff arthropathy. This project aims at a retrospective analysis of preexisting risk factors for sustaining rotator cuff injury as well as for failing to reach the previous functional level, used surgical technique -either single row repair or double row repair- and its significance for the functional outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single row repair technique | – | Other: single row repair techniquepatients surgically treated for rotator cuff lesion by single row repair technique |
| double row repair technique | – | Other: double row repair techniquepatients surgically treated for rotator cuff lesion by double row repair technique |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated for rotator cuff lesion either traumatic or degenerative at the University Hospital Basel and Kantonsspital BaselLand between 01.01.2015 and 30.1.2018
Key inclusion criteria (3 listed)
- Treated by single row or double row repair technique for shoulder's rotator cuff tears
- Time lapse from injury to surgery ranges from one day to less than 1 year
- Availability of clinical and radiological outcomes from 6 months to 1 year follow up
Key exclusion criteria (3 listed)
- Massive irreparable tear
- Patient has frozen shoulder
- Chronically retracted tendons and atrophic rotator cuff muscles
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 |
|---|---|---|
| single row repair techniquesingle row repair technique | Other | single row repair technique |
| double row repair techniquedouble row repair technique | Other | double row repair technique |
Primary outcome
Radiologic assessment of surgical treatment of rotator cuff tear
Time frame: directly postoperative (within 24 hours after surgery)
X-ray shoulder for assessment of acromiohumeral space and morphology (Millimeters)
Magnetic resonance imaging (MRI) of surgical treatment of rotator cuff tear
Time frame: directly postoperative (within 24 hours after surgery)
MRI shoulder to asses morphology of shoulder
Ultrasonography of surgical treatment of rotator cuff tear
Time frame: From 6 months up to 1 year postoperative
Ultrasonography to evaluate the healing of the tendon at the bone interface and degree of gap Formation (degree)
4 secondary outcomes
Active range of motion
Time frame: At six months and one year follow up after surgery
Passive range of motion
Time frame: At six months and one year follow up after surgery
Use of analgesics
Time frame: At six months after surgery
Use of analgesics
Time frame: At one year follow up after 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 12 Mar 2020.
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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.
Mohy Taha, Dr. med principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Injury, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 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: finished, as of the sponsor's last update on 12 Mar 2020. 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 Switzerland. 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?
Radiologic assessment of surgical treatment of rotator cuff tear (time frame: directly postoperative (within 24 hours after surgery)). The study lists 3 primary outcomes in all. 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 12 Mar 2020.