Rotator Cuff TearTENS-RCTNCT03318627
Influence of Intraoperative Repair Tension on Postoperative Healing of Full-thickness Rotator Cuff Tears
A study testing Sterile Spring Scale in people with Rotator Cuff Tear, run by Balgrist University Hospital.
Trial summary
Relevant problems of rotator cuff repair: High retear rate after rotator cuff repair of 13%, despite regard of the criteria for "reparability" of a tear. Long and exhausting rehabilitation after rotator cuff repair with an abduction splint for six weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Sterile Spring Scale
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2020to 6 Jul 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Male/female from 18-99 years
- All arthroscopic reparable transmural supra-/infraspinatus tears
- German speaking
Who cannot join
- Previous operation on the ipsilateral rotator cuff
- Irreparable rotator cuff tear (supra- and / or infraspinatus and / or subscapularis)
- static antero-superior subluxation of humeral head
- dynamic antero-superior subluxation of humeral head
- pseudoparalysis for anteflexion, hornblow sign, dropping- arm sign
- fatty infiltration goutallier 3-4 (MRI)
Show all 10Show fewer
- reduced acromiohumeral distance <7mm (RX)
- intraoperative not reparable
- Mild/severe osteoarthritis (RX, Hamada II-IV)
- Inability of patient (language problems, mental illness, dementia)
About this study
Relevant problems of rotator cuff repair:
- High retear rate after rotator cuff repair of 13%, despite regard of the criteria for "reparability" of a tear.
- Long and exhausting rehabilitation after rotator cuff repair with an abduction splint for six weeks.
Read more
Hypothesis:
The investigators believe that high tension repair has a higher retear rate than low tension repair, regardless of the tear size. The investigators also believe that abduction of the arm can reduce relevant tension on the repair. But not each repair benefits equally from this.
Relevance of this hypothesis:
The ingenious advantage of this new parameter (intraoperative repair tension) is, that it can be influenced. In future, if this hypothesis would be true, the repair tension could be reduced intraoperative by release, side-to-side (margin convergence) repair or medialization of the footprint and thereby convert a high risk to a low risk tension repair.
Moreover, it could be that patients with a low tension repair does not necessarily have to wear an abduction splint. And on the other hand, high tension repair patients should probably wear the abduction splint longer with gradually reduction.
Approach:
The present research plan focused on a new intraoperative (arthroscopic) determinable parameter ("repair tension" on footprint in 0° and 40° abduction) to determine the risk of recurrence after tendon repair in rotator cuff tears, which are pre- and intraoperative defined as "reparable". Therefore, the tension of the repaired tendon is measured intraoperative with a spring balance (newtonmeter) and correlated with the postoperative retear-rate.
- Measure intraoperative repair tension with the arm in 0° and 40° of abduction
Read the detailed description
How the investigators plan the study:
This is a prospective clinical study, risk category A. It is one-armed (all participants have the same procedure/rehabilitation) and single-blinded (participants doesn't knows the repair tension).
The investigators are an orthopaedic clinic in Zurich (Universitätsklinik Balgrist, Zürich) with about 250 arthroscopic rotator cuff repairs per year. Our plan is to recruit at least 100 participants in a year for this prospective clinical study. The participants have to fulfill the inclusion criterions. The diagnosis for the rotator cuff tears are made on the basis of arthro-MRI scans. The investigators do the operations in our clinic. The entire follow-up is one year for each participant. We plan three regular postoperative consultations. The tendon healing is controlled postoperative by ultrasound (six weeks and 4 month postoperative) and by MRI (one year postoperative).
Visit 0: participant recruitment:
The participants who are suitable for the study, will be recruited in the clinic for the study. They are aware of the essential information and the process and have 14 days time to read the information paper.
Visit 1: preoperative phase:
The following parameters are collected by default:
- Constant score
- Begin of symptoms (subjective shoulder value, visual analogue scale)
- Questionnaire
- Arthro-MRI (fatty infiltration, tear size, tendon retraction, length of central tendon)
- RX (Critical Shoulder Angle)
Visit 2: intraoperative phase:
The intraoperative procedure is standardized:
Postoperative immobilisation in an abduction splint in 40° abduction with passive mobilisation (physiotherapy) without adduction for six weeks.
Visit 3: 6 weeks postoperative phase:
The following parameters are collected by default:
- Clinical examination
- Subjective shoulder value
- Pain-VAS
- Questionnaire
- Complications
- Ultrasound (retear yes/no) The abduction splint is removed. Other six weeks mobilisation active and active-assisted without weights and strength until the 12th week (clinic standard).
Visit 4: 4 months postoperative phase:
The following parameters are collected by default:
- Clinical examination
- Active ROM (abduction, flexion, external rotation)
- Passive ROM (glenohumeral abduction, external rotation)
- Subjective shoulder value
- Pain-VAS
- Questionnaire
- Complications
- Ultrasound (retear yes/no) There is an increase in strength and agility
Visit 5: 1 year postoperative phase:
The following parameters are collected by default:
- Clinical examination
- Passive ROM (glenohumeral abduction, external rotation)
- Subjective shoulder value
- Pain-VAS
- Constant score
- Questionnaire
- Complications
- MRI (fatty infiltration)
- X-ray (critical shoulder value) The study is finished for the patient
How the investigators can realise the aims:
Aim 1: Correlation of intraoperative repair tension in 0° and 40° abduction on footprint with postoperative healing.
The investigators measure intraoperative repair tension for each participant in 0° and 40° abduction in gram with a spring balance. Then, measurement of healing rate of these tendon reconstructions over one year. The investigators do three regular follow-ups. In week 6 and month 4, control of healing with ultrasound and one year postoperative with an MRI scan. Intraoperative repair tension is correlated with retear rate. Cut-off value to separate high risk and low risk tension repairs is evaluated.
Aim 2: Correlation of other parameters with postoperative healing: The investigator correlate other parameters with the postoperative healing. Following parameters are collected in preoperative MRI scans: tear size in cm, tear retraction in cm, central tendon length in cm, fatty infiltration with the classification of Goutallier I-IV. In preoperative x-rays we measure the critical shoulder angle in degree. Intraoperative measurement of: tendon quality in four stages and the tear pattern visual (see above, "Visit 2").
Aim 3: Can intraoperative repair tension be predicted preoperative by MRI findings?: For this question, measurement of following parameters: tendon size in cm, tendon retraction in cm, length of central tendon in cm and fatty infiltration with the classification of Goutallier I-IV. Statistical evaluation with correlation of intraoperative repair tension with these MRI findings.
Aim 4: Correlation of high repair tension with pain: Correlation of pain with repair tension. Measurement of pain in each consultation with a visual analogue scale from 0-10 (0 no pain, 10 very much pain). Measurement range of motion of the participants (active and passive) and correlate stiffness with pain and with repair tension.
Aim 5: Correlation of repair tension with postoperative muscle atrophy, fatty infiltration and tendon length: Measurement of muscle atrophy, fatty infiltration and tendon length in the MRI scan preoperative and one year postoperative to compare. The muscle atrophy is quantified with tangent sign and occupation ratio. Fatty infiltration with the classification of Goutallier and tendon length in cm. Then, correlation pre- and postoperative changes with the repair tension.
Aim 6: Lower retear rate in type B- and C-reconstruction compared to type A- reconstruction? (type A-C) If possible, the investigators want to correlate different reconstruction types (A-C) with similar tension repairs.
- Conditions
- Rotator Cuff Tear
- Being tested
- Sterile Spring Scale
- 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.
Sterile Spring ScaleDevice
Measuring intraoperative tension of tendon of rotator cuff tear
| Study group | Role | What they receive |
|---|---|---|
| Tension Measuring | Other | Measuring intraoperative tension of rotator cuff tendon with sterile spring Balance. Receives: Device: Sterile Spring Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon tension
Measuring tendon Tension according to the footprint in 0° and 45° abduction with a Newtonmeter.
Measured: during surgery
Secondary outcomes (1)
Rotator cuff re-tear
Evaluation re-tear of repaired rotator cuff in MRI scan
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start6 Jul 2020
- Primary completion6 Jul 2020
- Study completion6 Jul 2020
Why it stopped: No capacity to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318627
- Sponsor's protocol ID
- 2015-00236
- Other IDs
- 2015
- Acronym
- TENS-RCT
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le BT, Wu XL, Lam PH, Murrell GA. Factors predicting rotator cuff retears: an analysis of 1000 consecutive rotator cuff repairs. Am J Sports Med. 2014 May;42(5):1134-42. doi: 10.1177/0363546514525336. Epub 2014 Apr 18.
PubMed 24748610Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.
PubMed 15930531Thomazeau H, Boukobza E, Morcet N, Chaperon J, Langlais F. Prediction of rotator cuff repair results by magnetic resonance imaging. Clin Orthop Relat Res. 1997 Nov;(344):275-83.
PubMed 9372778Meyer DC, Wieser K, Farshad M, Gerber C. Retraction of supraspinatus muscle and tendon as predictors of success of rotator cuff repair. Am J Sports Med. 2012 Oct;40(10):2242-7. doi: 10.1177/0363546512457587. Epub 2012 Aug 27.
PubMed 22926748Liem D, Lichtenberg S, Magosch P, Habermeyer P. Magnetic resonance imaging of arthroscopic supraspinatus tendon repair. J Bone Joint Surg Am. 2007 Aug;89(8):1770-6. doi: 10.2106/JBJS.F.00749.
PubMed 17671017
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intraoperative Repair Tension on Postoperative Healing of Full-thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT03318627
- Acronym / sponsor ID
- TENS-RCT / 2015-00236
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No capacity to conduct the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 24 Oct 2017 (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.
Relevant problems of rotator cuff repair:
- High retear rate after rotator cuff repair of 13%, despite regard of the criteria for "reparability" of a tear.
- Long and exhausting rehabilitation after rotator cuff repair with an abduction splint for six weeks.
Hypothesis:
The investigators believe that high tension repair has a higher retear rate than low tension repair, regardless of the tear size. The investigators also believe that abduction of the arm can reduce relevant tension on the repair. But not each repair benefits equally from this.
Relevance of this hypothesis:
The ingenious advantage of this new parameter (intraoperative repair tension) is, that it can be influenced. In future, if this hypothesis would be true, the repair tension could be reduced intraoperative by release, side-to-side (margin convergence) repair or medialization of the footprint and thereby convert a high risk to a low risk tension repair.
Moreover, it could be that patients with a low tension repair does not necessarily have to wear an abduction splint. And on the other hand, high tension repair patients should probably wear the abduction splint longer with gradually reduction.
Approach:
The present research plan focused on a new intraoperative (arthroscopic) determinable parameter ("repair tension" on footprint in 0° and 40° abduction) to determine the risk of recurrence after tendon repair in rotator cuff tears, which are pre- and intraoperative defined as "reparable". Therefore, the tension of the repaired tendon is measured intraoperative with a spring balance (newtonmeter) and correlated with the postoperative retear-rate.
- Measure intraoperative repair tension with the arm in 0° and 40° of abduction
Detailed description
How the investigators plan the study:
This is a prospective clinical study, risk category A. It is one-armed (all participants have the same procedure/rehabilitation) and single-blinded (participants doesn't knows the repair tension).
The investigators are an orthopaedic clinic in Zurich (Universitätsklinik Balgrist, Zürich) with about 250 arthroscopic rotator cuff repairs per year. Our plan is to recruit at least 100 participants in a year for this prospective clinical study. The participants have to fulfill the inclusion criterions. The diagnosis for the rotator cuff tears are made on the basis of arthro-MRI scans. The investigators do the operations in our clinic. The entire follow-up is one year for each participant. We plan three regular postoperative consultations. The tendon healing is controlled postoperative by ultrasound (six weeks and 4 month postoperative) and by MRI (one year postoperative).
Visit 0: participant recruitment:
The participants who are suitable for the study, will be recruited in the clinic for the study. They are aware of the essential information and the process and have 14 days time to read the information paper.
Visit 1: preoperative phase:
The following parameters are collected by default:
- Constant score
- Begin of symptoms (subjective shoulder value, visual analogue scale)
- Questionnaire
- Arthro-MRI (fatty infiltration, tear size, tendon retraction, length of central tendon)
- RX (Critical Shoulder Angle)
Visit 2: intraoperative phase:
The intraoperative procedure is standardized:
Postoperative immobilisation in an abduction splint in 40° abduction with passive mobilisation (physiotherapy) without adduction for six weeks.
Visit 3: 6 weeks postoperative phase:
The following parameters are collected by default:
- Clinical examination
- Subjective shoulder value
- Pain-VAS
- Questionnaire
- Complications
- Ultrasound (retear yes/no) The abduction splint is removed. Other six weeks mobilisation active and active-assisted without weights and strength until the 12th week (clinic standard).
Visit 4: 4 months postoperative phase:
The following parameters are collected by default:
- Clinical examination
- Active ROM (abduction, flexion, external rotation)
- Passive ROM (glenohumeral abduction, external rotation)
- Subjective shoulder value
- Pain-VAS
- Questionnaire
- Complications
- Ultrasound (retear yes/no) There is an increase in strength and agility
Visit 5: 1 year postoperative phase:
The following parameters are collected by default:
- Clinical examination
- Passive ROM (glenohumeral abduction, external rotation)
- Subjective shoulder value
- Pain-VAS
- Constant score
- Questionnaire
- Complications
- MRI (fatty infiltration)
- X-ray (critical shoulder value) The study is finished for the patient
How the investigators can realise the aims:
Aim 1: Correlation of intraoperative repair tension in 0° and 40° abduction on footprint with postoperative healing.
The investigators measure intraoperative repair tension for each participant in 0° and 40° abduction in gram with a spring balance. Then, measurement of healing rate of these tendon reconstructions over one year. The investigators do three regular follow-ups. In week 6 and month 4, control of healing with ultrasound and one year postoperative with an MRI scan. Intraoperative repair tension is correlated with retear rate. Cut-off value to separate high risk and low risk tension repairs is evaluated.
Aim 2: Correlation of other parameters with postoperative healing: The investigator correlate other parameters with the postoperative healing. Following parameters are collected in preoperative MRI scans: tear size in cm, tear retraction in cm, central tendon length in cm, fatty infiltration with the classification of Goutallier I-IV. In preoperative x-rays we measure the critical shoulder angle in degree. Intraoperative measurement of: tendon quality in four stages and the tear pattern visual (see above, "Visit 2").
Aim 3: Can intraoperative repair tension be predicted preoperative by MRI findings?: For this question, measurement of following parameters: tendon size in cm, tendon retraction in cm, length of central tendon in cm and fatty infiltration with the classification of Goutallier I-IV. Statistical evaluation with correlation of intraoperative repair tension with these MRI findings.
Aim 4: Correlation of high repair tension with pain: Correlation of pain with repair tension. Measurement of pain in each consultation with a visual analogue scale from 0-10 (0 no pain, 10 very much pain). Measurement range of motion of the participants (active and passive) and correlate stiffness with pain and with repair tension.
Aim 5: Correlation of repair tension with postoperative muscle atrophy, fatty infiltration and tendon length: Measurement of muscle atrophy, fatty infiltration and tendon length in the MRI scan preoperative and one year postoperative to compare. The muscle atrophy is quantified with tangent sign and occupation ratio. Fatty infiltration with the classification of Goutallier and tendon length in cm. Then, correlation pre- and postoperative changes with the repair tension.
Aim 6: Lower retear rate in type B- and C-reconstruction compared to type A- reconstruction? (type A-C) If possible, the investigators want to correlate different reconstruction types (A-C) with similar tension repairs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tension Measuring | Other | Device: Sterile Spring ScaleMeasuring intraoperative tension of rotator cuff tendon with sterile spring Balance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Male/female from 18-99 years
- All arthroscopic reparable transmural supra-/infraspinatus tears
- German speaking
Key exclusion criteria (10 listed)
- Previous operation on the ipsilateral rotator cuff
- Irreparable rotator cuff tear (supra- and / or infraspinatus and / or subscapularis)
- static antero-superior subluxation of humeral head
- dynamic antero-superior subluxation of humeral head
- pseudoparalysis for anteflexion, hornblow sign, dropping- arm sign
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 |
|---|---|---|
| Sterile Spring ScaleMeasuring intraoperative tension of tendon of rotator cuff tear | Device | Tension Measuring |
Primary outcome
Tendon tension
Time frame: during surgery
Measuring tendon Tension according to the footprint in 0° and 45° abduction with a Newtonmeter.
1 secondary outcome
Rotator cuff re-tear
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Background: PubMed 24748610Le BT, Wu XL, Lam PH, Murrell GA. Factors predicting rotator cuff retears: an analysis of 1000 consecutive rotator cuff repairs. Am J Sports Med. 2014 May;42(5):1134-42. doi: 10.1177/0363546514525336. Epub 2014 Apr 18.
- Background: PubMed 15930531Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.
- Background: PubMed 9372778Thomazeau H, Boukobza E, Morcet N, Chaperon J, Langlais F. Prediction of rotator cuff repair results by magnetic resonance imaging. Clin Orthop Relat Res. 1997 Nov;(344):275-83.
- Background: PubMed 22926748Meyer DC, Wieser K, Farshad M, Gerber C. Retraction of supraspinatus muscle and tendon as predictors of success of rotator cuff repair. Am J Sports Med. 2012 Oct;40(10):2242-7. doi: 10.1177/0363546512457587. Epub 2012 Aug 27.
- Background: PubMed 17671017Liem D, Lichtenberg S, Magosch P, Habermeyer P. Magnetic resonance imaging of arthroscopic supraspinatus tendon repair. J Bone Joint Surg Am. 2007 Aug;89(8):1770-6. doi: 10.2106/JBJS.F.00749.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tear
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile Spring Scale in people with Rotator Cuff Tear, run by Balgrist University Hospital.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Tendon tension (time frame: during 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 NCT03318627, which also lists 5 linked publications.
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 14 Jul 2020.