Rotator Cuff TearNCT01877772
Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled
A study testing Bone Trephination in people with Rotator Cuff Tear, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff repair; bone trephination."Trephination" is a procedure that involves making small perforations in the bone that the tendon is repaired to.The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Bone Trephination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Jan 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
- Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as:
- The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
- Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc)
- Activity modification
- Imaging, and intra-operative findings confirming a full thickness tear of the rotator cuff.
Who cannot join
- Characteristics of the cuff tear that render the cuff irrepairable:
- fatty infiltration in the muscles grade III (50%) or greater; superior subluxation of the humeral head; retraction of the cuff to the level of the glenoid rim.
- Partial thickness cuff tears.
- Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis
- Previous surgery on affected shoulder e.g. Previous rotator cuff repair.
- Isolated subscapularis tendon tears
Show all 16Show fewer
- Active joint or systemic infection
- Significant muscle paralysis
- Rotator cuff tear arthropathy
- Charcot's arthropathy
- Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)
- Major medical illness (life expectancy less then 1 year or unacceptably high operative risk)
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for 24 months
- Advanced physiologic age
Trial locations and contacts
1 site in 1 country.
About this study
This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff repair; bone trephination."Trephination" is a procedure that involves making small perforations in the bone that the tendon is repaired to.The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon. The control group will undergo the standard repair for rotator cuff tears.
It is the investigators' hypothesis that healing rates in patients who undergo bone trephination will be higher compared with surgery without trephination in arthroscopic rotator cuff repair at 24 months post-operatively.
Read the detailed description
Rotator cuff repair carried out with current techniques has shown favourable results in terms of pain relief. However the re-tear rates remain high and are associated with significant morbidity in terms of functional outcome and shoulder strength. As rotator cuff disease becomes ever more prevalent with our aging population, it is imperative to determine if healing rates can be improved with autologous stem cell enhancement with pre-surgical preparation of the tendon insertion site through trephination. This trial is necessary both to provide optimal care of our patients, and to do so in a fiscally responsible fashion.
The primary outcome measure the re-tear rate as measured by ultrasound at 24 months post-operatively.
The secondary outcome measures are Western Ontario Rotator Cuff Index (WORC), Constant Score, and the American Shoulder and Elbow surgeons standardized assessment of shoulder function (ASES).
- Conditions
- Rotator Cuff Tear
- Being tested
- Bone Trephination, Control
- Keywords
- cuff repair, arthroscopic, Trephination, Bone, cuff tear
- 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.
Bone TrephinationProcedure or surgery
For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.
ControlProcedure or surgery
The control group will undergo standard rotator cuff repair.
| Study group | Role | What they receive |
|---|---|---|
| Bone Trephination | Active comparator | For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus. Receives: Procedure: Bone Trephination; Procedure: Control |
| Control | Active comparator | The control group will undergo standard rotator cuff repair. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-resolution ultrasound
High-resolution ultrasound will be used as the primary outcome measure to determine the re-tear rate at 6 and 24 months following repair. Ultrasound was chosen as it has been shown to have a high degree of accuracy for the diagnosis of rotator tears that is equivalent but less expensive than MRI.
The interpretation of the high-resolution ultrasound is based on healing status and will be carried out by a trained MSK radiologist. Healing status will be documented at both 6 and 24 months as either completely healed, partially healed, or not healed. For tendons partially healed or not healed, the size of the defect will be compared with the size of the tear pre-operatively.
Measured: 6 and 24 months post op
Secondary outcomes (1)
Functional Outcome scores
WORC, ASES and Constant
Measured: baseline and 3, 6, 12, 18 and 24 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2020
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Panam Clinic, London Health Sciences Centre, University of Alberta
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877772
- Sponsor's protocol ID
- 2013-0211
- Status last verified
- Mar 2023
- First submitted
- 12 Jun 2013
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhao S, Liu G, Zhang D, Tang S. Intraoperative Channeling in Arthroscopic Rotator Cuff Repair: Letter to the Editor. Am J Sports Med. 2023 Jun;51(7):NP20. doi: 10.1177/03635465231169536. No abstract available.
PubMed 37259789Lapner P, Bouliane M, Pollock JW, Coupal S, Sabri E, Hodgdon T, Old J, Mcilquham K, MacDonald P; CSES Investigators:; Stranges G, Berdusco R, Marsh J, Dubberley J, McRae S. Intraoperative Channeling in Arthroscopic Rotator Cuff Repair: A Multicenter Randomized Controlled Trial. Am J Sports Med. 2023 Feb;51(2):323-330. doi: 10.1177/03635465221138562. Epub 2022 Dec 1.
PubMed 36453726
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled
- ClinicalTrials.gov ID
- NCT01877772
- Acronym / sponsor ID
- 2013-0211
- Conditions
- Rotator Cuff Tear
- Keywords
- cuff repair, arthroscopic, Trephination, Bone, cuff tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Panam Clinic, London Health Sciences Centre, University of Alberta
- Study start
- Jun 2013 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 14 Jun 2013 (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.
This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff repair; bone trephination."Trephination" is a procedure that involves making small perforations in the bone that the tendon is repaired to.The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon. The control group will undergo the standard repair for rotator cuff tears.
It is the investigators' hypothesis that healing rates in patients who undergo bone trephination will be higher compared with surgery without trephination in arthroscopic rotator cuff repair at 24 months post-operatively.
Detailed description
Rotator cuff repair carried out with current techniques has shown favourable results in terms of pain relief. However the re-tear rates remain high and are associated with significant morbidity in terms of functional outcome and shoulder strength. As rotator cuff disease becomes ever more prevalent with our aging population, it is imperative to determine if healing rates can be improved with autologous stem cell enhancement with pre-surgical preparation of the tendon insertion site through trephination. This trial is necessary both to provide optimal care of our patients, and to do so in a fiscally responsible fashion.
The primary outcome measure the re-tear rate as measured by ultrasound at 24 months post-operatively.
The secondary outcome measures are Western Ontario Rotator Cuff Index (WORC), Constant Score, and the American Shoulder and Elbow surgeons standardized assessment of shoulder function (ASES).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone Trephination | Active comparator | Procedure: Bone Trephination, Procedure: ControlFor the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus. |
| Control | Active comparator | Procedure: ControlThe control group will undergo standard rotator cuff repair. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
- Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as:
- Imaging, and intra-operative findings confirming a full thickness tear of the rotator cuff.
Key exclusion criteria (16 listed)
- Characteristics of the cuff tear that render the cuff irrepairable:
- fatty infiltration in the muscles grade III (50%) or greater; superior subluxation of the humeral head; retraction of the cuff to the level of the glenoid rim.
- Partial thickness cuff tears.
- Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis
- Previous surgery on affected shoulder e.g. Previous rotator cuff repair.
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 |
|---|---|---|
| Bone TrephinationFor the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus. | Procedure or surgery | Bone Trephination |
| ControlThe control group will undergo standard rotator cuff repair. | Procedure or surgery | Bone Trephination, Control |
Primary outcome
High-resolution ultrasound
Time frame: 6 and 24 months post op
High-resolution ultrasound will be used as the primary outcome measure to determine the re-tear rate at 6 and 24 months following repair. Ultrasound was chosen as it has been shown to have a high degree of accuracy for the diagnosis of rotator tears that is equivalent but less expensive than MRI. The interpretation of the high-resolution ultrasound is based on healing status and will be carried out by a trained MSK radiologist. Healing status will be documented at both 6 and 24 months as either completely healed, partially healed, or not healed. For tendons partially healed or not healed, the size of the defect will be compared with the size of the tear pre-operatively.
1 secondary outcome
Functional Outcome scores
Time frame: baseline and 3, 6, 12, 18 and 24 months post op
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 3 Mar 2023.
- Derived from this study: PubMed 37259789Zhao S, Liu G, Zhang D, Tang S. Intraoperative Channeling in Arthroscopic Rotator Cuff Repair: Letter to the Editor. Am J Sports Med. 2023 Jun;51(7):NP20. doi: 10.1177/03635465231169536. No abstract available.
- Derived from this study: PubMed 36453726Lapner P, Bouliane M, Pollock JW, Coupal S, Sabri E, Hodgdon T, Old J, Mcilquham K, MacDonald P; CSES Investigators:; Stranges G, Berdusco R, Marsh J, Dubberley J, McRae S. Intraoperative Channeling in Arthroscopic Rotator Cuff Repair: A Multicenter Randomized Controlled Trial. Am J Sports Med. 2023 Feb;51(2):323-330. doi: 10.1177/03635465221138562. Epub 2022 Dec 1.
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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.
Peter Lapner, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Trephination in people with Rotator Cuff Tear, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 6 inclusion and 16 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 3 Mar 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 Canada. 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?
High-resolution ultrasound (time frame: 6 and 24 months post op). 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 NCT01877772, which also lists 2 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 3 Mar 2023.