Rotator Cuff TearsBIOHACKNCT04618484
Biomodulating Rotator Cuff Healing - A Proof of Concept Trial
A study testing Biomodulation (non-pharmacological) in people with Rotator Cuff Tears, run by Clinique Générale dAnnecy at 1 site in France.
Trial summary
Novel concepts in quantum biology of rotator cuff repair and author's novel findings on biomodulation inspired us to design a pragmatic non-pharmacological add-on rehabilitation protocol that may potentially decrease retear rates after arthroscopic repair using a knotted suturebridge technique. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Biomodulation (non-pharmacological)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to Dec 2024
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is over 18 years old
- Patient presents with a symptomatic full-thickness tear as diagnosed preoperatively on ultrasound, arthro-CT or MRI.
- Absence of significant muscle atrophy or fatty infiltration of the affected tendon exceeding stage 2 of the Goutallier classification
Who cannot join
- Partial rotator cuff tear or other shoulder injury
- Planned concomitant procedures other than subacromial decompression, acromioclavicular joint resection or biceps tenodesis/tenotomy
- Irreparable rotator cuff tear
- Patients who present with cartilage lesions greater than stage II of the Outerbridge classification (≥15mm diameter) on preoperative x-ray
- Patient presenting with a known comorbidity that could affect the outcome of surgery (cervical radiculopathy, polyarthritis, neurological disease of the upper limb)
- Patient not able to give informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique Générale d'Annecy
Annecy
Geert-Alexander BUIZJE, MD, gabuijze@hotmail.com
About this study
Official title: Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?
Novel concepts in quantum biology of rotator cuff repair and author's novel findings on biomodulation inspired us to design a pragmatic non-pharmacological add-on rehabilitation protocol that may potentially decrease retear rates after arthroscopic repair using a knotted suturebridge technique. In this proof-of-concept trial, 146 patients will be randomized 1:1 to either a 6-weeks post-operative cryo-, photo- and electro-biomodulation protocol or a control group immobilized in a standard abduction sling for 6 weeks. Healing will be evaluated using the Sugaya classification on MRI at 1 year post-operatively.
- Conditions
- Rotator Cuff Tears
- Being tested
- Biomodulation (non-pharmacological)
- 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.
Biomodulation (non-pharmacological)Other
cryo-, photo- and electro-biomodulation
| Study group | Role | What they receive |
|---|---|---|
| Biomodulation | Experimental | 6-weeks post-operative cryo-, photo- and electro-biomodulation protocol after repair Receives: Other: Biomodulation (non-pharmacological) |
| Control | No intervention | standard rehabilitation after repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of rotator cuff tear
Healing will be evaluated using the Sugaya classification on MRI
Measured: 1 year post-operatively
Secondary outcomes (4)
Patient reported outcome measures
Pain, reported as average of reported pain during movement, at rest and at night, measured by a numeric rating scale from 0 to 10; and the Auto-Constant score, Subjective Shoulder Value, the American Shoulder and Elbow Surgeon score Surgeon score
Measured: 6 months and 1 year
Active range of motion
Degrees of forward flexion, abduction, internal rotation and external rotation (90 degrees elbow flexion, 0 and 90 degrees abduction)
Measured: 6 months and 1 year
Compliance
Self-reported daily compliance to the different components of the biomodulation protocol
Measured: First 6 weeks after surgery
Postoperative complications
Postoperative complications in the first year after surgery
Measured: First year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Dec 2021
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (estimated)
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 Rotator Cuff TearsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Générale dAnnecy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geert Alexander Buijze, Clinique Générale dAnnecy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618484
- Sponsor's protocol ID
- 2020BIOHACK-trial
- Acronym
- BIOHACK
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 2020
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy reasons individual patient data will not be available to the public.
Publications
Allaart LJH, Lech J, Macken AA, Kling A, Lafosse L, Lafosse T, van den Bekerom MPJ, Buijze GA. Biomodulating healing after arthroscopic rotator cuff repair: the protocol of a randomised proof of concept trial (BIOHACK). BMJ Open. 2023 Aug 16;13(8):e071078. doi: 10.1136/bmjopen-2022-071078.
PubMed 37586862
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?
- ClinicalTrials.gov ID
- NCT04618484
- Acronym / sponsor ID
- BIOHACK / 2020BIOHACK-trial
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Clinique Générale dAnnecyUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Nov 2020 (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.
Novel concepts in quantum biology of rotator cuff repair and author's novel findings on biomodulation inspired us to design a pragmatic non-pharmacological add-on rehabilitation protocol that may potentially decrease retear rates after arthroscopic repair using a knotted suturebridge technique. In this proof-of-concept trial, 146 patients will be randomized 1:1 to either a 6-weeks post-operative cryo-, photo- and electro-biomodulation protocol or a control group immobilized in a standard abduction sling for 6 weeks. Healing will be evaluated using the Sugaya classification on MRI at 1 year post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Biomodulation | Experimental | Other: Biomodulation (non-pharmacological)6-weeks post-operative cryo-, photo- and electro-biomodulation protocol after repair |
| Control | No intervention | –standard rehabilitation after repair |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is over 18 years old
- Patient presents with a symptomatic full-thickness tear as diagnosed preoperatively on ultrasound, arthro-CT or MRI.
- Absence of significant muscle atrophy or fatty infiltration of the affected tendon exceeding stage 2 of the Goutallier classification
Key exclusion criteria (6 listed)
- Partial rotator cuff tear or other shoulder injury
- Planned concomitant procedures other than subacromial decompression, acromioclavicular joint resection or biceps tenodesis/tenotomy
- Irreparable rotator cuff tear
- Patients who present with cartilage lesions greater than stage II of the Outerbridge classification (≥15mm diameter) on preoperative x-ray
- Patient presenting with a known comorbidity that could affect the outcome of surgery (cervical radiculopathy, polyarthritis, neurological disease of the upper limb)
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 |
|---|---|---|
| Biomodulation (non-pharmacological)cryo-, photo- and electro-biomodulation | Other | Biomodulation |
Primary outcome
Healing of rotator cuff tear
Time frame: 1 year post-operatively
Healing will be evaluated using the Sugaya classification on MRI
4 secondary outcomes
Patient reported outcome measures
Time frame: 6 months and 1 year
Active range of motion
Time frame: 6 months and 1 year
Compliance
Time frame: First 6 weeks after surgery
Postoperative complications
Time frame: First year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 37586862Allaart LJH, Lech J, Macken AA, Kling A, Lafosse L, Lafosse T, van den Bekerom MPJ, Buijze GA. Biomodulating healing after arthroscopic rotator cuff repair: the protocol of a randomised proof of concept trial (BIOHACK). BMJ Open. 2023 Aug 16;13(8):e071078. doi: 10.1136/bmjopen-2022-071078.
- Individual participant dataSharing planned: No. Due to privacy reasons individual patient data will not be available to the public.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomodulation (non-pharmacological) in people with Rotator Cuff Tears, run by Clinique Générale dAnnecy at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of rotator cuff tear (time frame: 1 year post-operatively). 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 NCT04618484, 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 3 Jul 2023.