Rotator Cuff TearsNCT05925881
Lower Trapezius Transfer vs Bridging Reconstruction
A study testing Surgical Repair of Large to Massive Rotator Cuff Tears in people with Rotator Cuff Tears, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The goal of this clinical trial is to compare the bridging reconstruction technique vs the lower trapezius tendon transfer in patients with massive irreparable rotator cuff tears. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Surgical Repair of Large to Massive Rotator Cuff Tears
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- magnetic resonance imaging (MRI) proven diagnosis of a massive rotator cuff tear
- tear size >5cm
- two-tendon, irreparable tear
- competent adult (>18 years of age)
- <50% muscle atrophy.
Who cannot join
- irreparable subscapular tear
- glenohumeral osteoarthritis
- WORC score > 70
- uncontrolled diabetes (Hgb A1C >7%)
- pregnancy
- presence of local or systemic infection
Show all 11Show fewer
- inability to cooperate with and/or comprehend post-operative instructions
- cancer
- paralysis of the shoulder
- contracture of the shoulder
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
5955 Veterans' Memorial Lane Room 2106, VMB
Halifax, Nova Scotia, B3H 2E1
Ivan Wong, Dr., 9024737627, research@drivanwong.com
Devan Pancura, MSc, 9024737627, research@drivanwong.con
About this study
Official title: Arthroscopic Assisted Lower Trapezius Tendon Transfer vs Bridging Repair for Irreparable Rotator Cuff Tears: A Randomized Controlled Trial
The goal of this clinical trial is to compare the bridging reconstruction technique vs the lower trapezius tendon transfer in patients with massive irreparable rotator cuff tears.
The main questions it aims to answer are:
Read more
- comparing the outcomes of the two surgical techniques (BRR with an acellular human dermal allograft implant vs Arthroscopic Assisted LTT Transfer) on the maintenance of the acromiohumeral distance
- compare the outcomes of strength, range of motion, and patient reported quality of life scores between the two techniques
Participants will be randomized into one of two surgical treatment groups (bridging reconstruction or lower trapezius tendon transfer) and followed for a minimum of two years to compare the outcomes between groups.
Read the detailed description
Research Plan: A total of 60 patients will be enrolled in the study. In the pre-operative period, there will be no additional time requirements for the patient, except for the informed consent process for the study. Routine radiographs including an AP and Y view of the shoulder as well as a pre-operative MRI are obtained for all patients undergoing rotator cuff surgery.
The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant. The examination will consist of range of motion testing by goniometer, range of motion testing evaluated by one's reach envelope, as well as strength testing by hand dynamometer. The patient will also complete the Western Ontario Rotator Cuff Index (WORC) questionnaire.
Randomization: Randomization will be done with a computer random number generator. Treatment conditions will be inserted in ordered opaque envelopes. Two groups (bridging reconstruction, and lower trapezius transfer) will be selected with 30 subjects each group.
Surgical Procedures: Wong et al. (2021) described the surgical procedure for patients in the "Bridging" group. The bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed into the remnants of supraspinatus and infraspinatus tendons. The patch is then attached to the greater tuberosity in a double row configuration.
The lower trapezius transfer will be performed as described by Wagner et. al. (2018). Patients will be placed in beach chair position, with the ipsilateral half of the back uncovered for surgical access. A 5-cm vertical skin incision will be made 1 cm from the medial border of scapula by the upper and lower edge of the lower trapezius tendon. The fat area at the inferior edge of the lower trapezius tendon will be identified, and the lower trapezius tendon will be completely released from spine of scapula and medially through opening of the superficial fascia. Two sutures in a Krakow configuration will be placed in the lower trapezius tendon. 2 sutures of different colors will be placed in the thick part of the allograft in a Krakow configuration. Designated ventral and dorsal aspects of the allograft will be marked. The infraspinatus fascia will be opened at the level of the medial incision. The sutures in the thick part of the allograft are then clamped to bring the graft intra-articular. Each of the Krakow sutures placed in the thick end of the allograft are passed to each of the 2 loadable suture anchors to attach the most distal part of the allograft, fixating the graft.
Postoperative protocol: The shoulder will be immobilized in a sling for one week postoperatively, and only passive forward flexion and external rotation will be allowed for eight weeks. The patient then progresses to active shoulder motion. Strengthening will begin at twelve weeks postoperatively. The patient will follow-up with the attending surgeon (IW) at 2 weeks post-operatively for a wound check. Then further clinical follow-up appointments will be at 6 weeks, 3 months, 6 months, 12 and 24 months, as per current clinical practice.
At the 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant who is blinded to the patients' treatment group. The patient will also complete the WORC questionnaire at these follow-up appointments. Radiographs will be taken also to obtain the postoperative measurements. MRI will be done to assess healing at 12 months.
Analysis of Data: The data collected will be analyzed through SPSS version 24. Two-tailed independent t-tests will be performed for the WORC, acromiohumeral distance, range of motion, and strength measures comparing the two groups at most recent postoperative measurement. Repeated-measures ANOVA will be used to assess differences in WORC scores, range of motion and strength within each group between time points.
- Conditions
- Rotator Cuff Tears
- Being tested
- Surgical Repair of Large to Massive Rotator Cuff Tears
- 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.
Surgical Repair of Large to Massive Rotator Cuff TearsProcedure or surgery
Surgical procedure to reconstruct the rotator cuff
| Study group | Role | What they receive |
|---|---|---|
| Lower Trapezius Tendon Transfer | Active comparator | The lower trapezius tendon transfer arm will consist of patients randomized to this surgical procedure. This is an arthroscopically assisted open procedure that involves harvesting of the lower trapezius muscle tendon and re-grafting it onto to shoulder to repair massive rotator cuff tears. Receives: Procedure: Surgical Repair of Large to Massive Rotator Cuff Tears |
| Bridging Reconstruction Repair | Active comparator | The bridging reconstruction repair arm will consist of patients randomized to this surgical procedure. This operation is arthroscopic, and involves the insertion of a human dermal allograft to the rotator cuff, sutured and anchored in a "bridging" fashion to repair massive rotator cuff tears. Receives: Procedure: Surgical Repair of Large to Massive Rotator Cuff Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acromiohumeral Distance
The acromiohumeral distance is the shortest distance between the inferior aspect of the acromion to the closest part of the humeral head. This outcome will be measured by a single blinded assessor who has medical training (sports medicine trained surgical fellow). Acromiohumeral distance will be measured on MRI scans taken at one year post-op.
Measured: 1 year
Secondary outcomes (3)
Range of Motion
Range of motion will be measured by a single independent blinded assessor who has appropriate training (sports medicine trained surgical fellow). Range of motion will be assessed for forward flexion, abduction, internal rotation and external rotation. All measures will be conducted using a goniometer and recorded in degrees.
Measured: 1 year
Strength
Strength will be measured by a single independent blinded assessor who has appropriate training (sports medicine trained surgical fellow). Strength will be measured during forward flexion, abduction of the shoulder, internal rotation and external rotation. All measures will be conducted using a handheld dynamometer and recorded in pounds.
Measured: 1 year
Patient-reported Outcomes (PROs)
PROs will be measured using the Western Ontario Rotator Cuff Index (WORC) and the Disabilities of the Arm, Shoulder, and Hands Questionnaire (DASH). The WORC is a series of questions regarding patient quality of life and activities of daily living with a rotator cuff pathology. The score is a numerical value on a scale from 1-100, with lower values indicating better outcomes. WORC outcome scores will be calculated as the change in pre- to post-operative WORC, where a change in score greater than 11.7 points meets the minimum clinically important difference. The DASH is a 30-item, self-report questionnaire that measures physical function and symptoms in people with disorders of the upper limb/s. The score is a numerical value on a scale from 1-100, with lower values indicating better outcomes. DASH outcome scores will compare the pre- to post-operative DASH, with a change in score greater than 10.81 indicating the minimum clinically important difference has been met.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start30 Oct 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Wong, MD, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925881
- Sponsor's protocol ID
- 52466
- Status last verified
- Feb 2025
- First submitted
- 13 Jun 2023
- Last updated
- 18 Feb 2025
- 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 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Assisted Lower Trapezius Tendon Transfer vs Bridging Repair for Irreparable Rotator Cuff Tears: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05925881
- Acronym / sponsor ID
- 52466
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 29 Jun 2023 (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.
The goal of this clinical trial is to compare the bridging reconstruction technique vs the lower trapezius tendon transfer in patients with massive irreparable rotator cuff tears.
The main questions it aims to answer are:
- comparing the outcomes of the two surgical techniques (BRR with an acellular human dermal allograft implant vs Arthroscopic Assisted LTT Transfer) on the maintenance of the acromiohumeral distance
- compare the outcomes of strength, range of motion, and patient reported quality of life scores between the two techniques
Participants will be randomized into one of two surgical treatment groups (bridging reconstruction or lower trapezius tendon transfer) and followed for a minimum of two years to compare the outcomes between groups.
Detailed description
Research Plan: A total of 60 patients will be enrolled in the study. In the pre-operative period, there will be no additional time requirements for the patient, except for the informed consent process for the study. Routine radiographs including an AP and Y view of the shoulder as well as a pre-operative MRI are obtained for all patients undergoing rotator cuff surgery.
The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant. The examination will consist of range of motion testing by goniometer, range of motion testing evaluated by one's reach envelope, as well as strength testing by hand dynamometer. The patient will also complete the Western Ontario Rotator Cuff Index (WORC) questionnaire.
Randomization: Randomization will be done with a computer random number generator. Treatment conditions will be inserted in ordered opaque envelopes. Two groups (bridging reconstruction, and lower trapezius transfer) will be selected with 30 subjects each group.
Surgical Procedures: Wong et al. (2021) described the surgical procedure for patients in the "Bridging" group. The bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed into the remnants of supraspinatus and infraspinatus tendons. The patch is then attached to the greater tuberosity in a double row configuration.
The lower trapezius transfer will be performed as described by Wagner et. al. (2018). Patients will be placed in beach chair position, with the ipsilateral half of the back uncovered for surgical access. A 5-cm vertical skin incision will be made 1 cm from the medial border of scapula by the upper and lower edge of the lower trapezius tendon. The fat area at the inferior edge of the lower trapezius tendon will be identified, and the lower trapezius tendon will be completely released from spine of scapula and medially through opening of the superficial fascia. Two sutures in a Krakow configuration will be placed in the lower trapezius tendon. 2 sutures of different colors will be placed in the thick part of the allograft in a Krakow configuration. Designated ventral and dorsal aspects of the allograft will be marked. The infraspinatus fascia will be opened at the level of the medial incision. The sutures in the thick part of the allograft are then clamped to bring the graft intra-articular. Each of the Krakow sutures placed in the thick end of the allograft are passed to each of the 2 loadable suture anchors to attach the most distal part of the allograft, fixating the graft.
Postoperative protocol: The shoulder will be immobilized in a sling for one week postoperatively, and only passive forward flexion and external rotation will be allowed for eight weeks. The patient then progresses to active shoulder motion. Strengthening will begin at twelve weeks postoperatively. The patient will follow-up with the attending surgeon (IW) at 2 weeks post-operatively for a wound check. Then further clinical follow-up appointments will be at 6 weeks, 3 months, 6 months, 12 and 24 months, as per current clinical practice.
At the 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant who is blinded to the patients' treatment group. The patient will also complete the WORC questionnaire at these follow-up appointments. Radiographs will be taken also to obtain the postoperative measurements. MRI will be done to assess healing at 12 months.
Analysis of Data: The data collected will be analyzed through SPSS version 24. Two-tailed independent t-tests will be performed for the WORC, acromiohumeral distance, range of motion, and strength measures comparing the two groups at most recent postoperative measurement. Repeated-measures ANOVA will be used to assess differences in WORC scores, range of motion and strength within each group between time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Trapezius Tendon Transfer | Active comparator | Procedure: Surgical Repair of Large to Massive Rotator Cuff TearsThe lower trapezius tendon transfer arm will consist of patients randomized to this surgical procedure. This is an arthroscopically assisted open procedure that involves harvesting of the lower trapezius muscle tendon and re-grafting it onto to shoulder to repair massive rotator cuff tears. |
| Bridging Reconstruction Repair | Active comparator | Procedure: Surgical Repair of Large to Massive Rotator Cuff TearsThe bridging reconstruction repair arm will consist of patients randomized to this surgical procedure. This operation is arthroscopic, and involves the insertion of a human dermal allograft to the rotator cuff, sutured and anchored in a "bridging" fashion to repair massive rotator cuff tears. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- magnetic resonance imaging (MRI) proven diagnosis of a massive rotator cuff tear
- tear size >5cm
- two-tendon, irreparable tear
- competent adult (>18 years of age)
- <50% muscle atrophy.
Key exclusion criteria (11 listed)
- irreparable subscapular tear
- glenohumeral osteoarthritis
- WORC score > 70
- uncontrolled diabetes (Hgb A1C >7%)
- pregnancy
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 |
|---|---|---|
| Surgical Repair of Large to Massive Rotator Cuff TearsSurgical procedure to reconstruct the rotator cuff | Procedure or surgery | Bridging Reconstruction Repair, Lower Trapezius Tendon Transfer |
Primary outcome
Acromiohumeral Distance
Time frame: 1 year
The acromiohumeral distance is the shortest distance between the inferior aspect of the acromion to the closest part of the humeral head. This outcome will be measured by a single blinded assessor who has medical training (sports medicine trained surgical fellow). Acromiohumeral distance will be measured on MRI scans taken at one year post-op.
3 secondary outcomes
Range of Motion
Time frame: 1 year
Strength
Time frame: 1 year
Patient-reported Outcomes (PROs)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Repair of Large to Massive Rotator Cuff Tears in people with Rotator Cuff Tears, run by Nova Scotia Health Authority 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acromiohumeral Distance (time frame: 1 year). 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 18 Feb 2025.