Arthroscopic Rotator Cuff RepairNCT06292754
Rotator Cuff Repair With Magnesium Pin
A study testing magnesium pin in additional to the suture anchor and routine suture anchor in people with Arthroscopic Rotator Cuff Repair, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Arthroscopic Rotator Cuff Repair
- What is being tested?
- magnesium pin in additional to the suture anchor and routine suture anchor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2024to Dec 2026
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject requires Arthroscopic rotator cuff repair (ARCR) and amenable to repair.
- Subject is > 40 years of age (no upper limit);
- Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;
- Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
Who cannot join
- Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
- Subjects with Samilson-Prieto osteoarthritis > 2;
- Subjects with current or prior infection of the ipsilateral shoulder;
- Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;
- Subjects with prior shoulder surgery (not including rotator cuff repair (revision repair subject group only), biceps tenodesis/tenotomy, distal clavicle excision (DCE), ubacromial decompression);
- Subjects with an irreparable or partially reparable rotator cuff tear;
Show all 14Show fewer
- Subjects with a subscapularis tear requiring repair;
- Subjects requiring a concomitant labral fixation procedure;
- Subjects requiring a concomitant os acromiale fixation procedure
- Subjects with glenohumeral joint instability (multiple dislocations/subluxations);
- Subjects with a subacromial or intra-articular injection within 3 months prior to surgery;
- Subjects with condition(s) that contraindicate or complicate outcomes of ARCR e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head or glenoid, history of immunodeficiency disorders, history of chronic inflammatory disorders, oral or injected steroid use in last 4 weeks;
- Pregnancy or possibility of pregnancy
- Patient's inability to understand written and spoken Chinese, Mandarin or English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Augmentation of Rotator Cuff Repair With Biodegradable Magnesium Pin: From Bench Side to Bedside
Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Arthroscopic rotator cuff repair (ARCR) is a surgical procedure to reattach the torn edge of the tendon to the underlying bone, which can improve the clinical symptoms of patients. However, the retear rate after arthroscopic repair is as high as 94% (1). The high re-tear rate following cuff repair is due to the lack of a strong tendon to bone integration. The natural healing responses after surgical reattachment are too weak to regenerate strong tendon insertion, primarily owing to insufficient osteogenesis. To enhance the bone-tendon interface (BTI) healing, the investigators have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.This study is a single-center, randomized controlled trial to investigate the effect of using magnesium pin as a suture to augment rotator cuff repair. The intervention groups receives treated using magnesium pin additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). The investigators hypothesize the magnesium pin applied in arthroscopic rotator cuff tears can promote BTI healing and reduce the cumulative retear rate with better functional outcomes.
Read the detailed description
Mechanical enhancement is a direct approach to enhance the bone-tendon interface (BTI) healing, which includes surgical techniques that seek to improve BTI healing through better fixation device. Favourable results would be achieved in the non-massively torn cases, improvement in the structural integrity and shoulder function were reported in the clinical studies. However, despite the improved initial biomechanical strength, high retear rate were still reported among the massive-teared patients, which indicates that enhancing the mechanical enhancement alone may not enough to promote the overall healing outcome. Other novel adjuvants to aid rotator cuff healing to promote bone tendon junction healing include growth factor supplementation, stem cells or biophysical intervention (5,6,7).
Tissue engineering is a promising strategy that would combine modern engineering techniques with novel biomaterials, cell therapy, growth factors, bioactive molecular. Enhancement of BTI healing with biomaterial, such as magnesium, may promote osteogenesis and thus improve the surgical outcome. These various approaches have been investigated in pre-clinical animal models of rotator cuff repair, yet further investigation to translate these into clinical practice is needed (8).
We have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.
The use of biodegradable materials as implants to stimulate healing has been developed in orthopaedics for decades. Our team and others reported that Mg-based interference screw or suture anchors could upregulate the expression of osteogenic and angiogenic factors experimentally, yet further investigation is still required to translate into clinical practice. However, the potential insufficient mechanical strength of Mg-based implants over the degradation period may result in a loss of fixation or failure of repair, which limits its clinical application. Herein, our novel magnesium pin showed good mechanical properties to be used to enhance the suture anchor commonly used for RCT repair in clinical practice. This can incorporate the benefit of an Mg-based component for its degradation and release of osteogenic and angiogenic by-products, but without the risk of compromising the integrity of the RCT repair site or the potentially osteoporotic bone at the repair site.
40 patients with rotator cuff tear scheduled for arthroscopic rotator cuff repair (ARCR) will be recruited from the Li Ka Shing Orthopaedic Specialist clinic at the Prince of Wales Hospital (PWH) Hong Kong.
Oral and written consents will be obtained from individuals who agree to participate in the study.
The recruitment period will last for 12 months and the whole project period is 2 years in total. Basic demographics, MRI assessment and Outcome Measurement Questionnaires will be carried out.
The intervention groups receive treated using magnesium pin in additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). Both treatments are conducted in clinical practices that are randomly allocated to either the intervention or the control condition. Participants are therefore randomized as their allocation depends on their practice being an intervention or a control practice.
Assessments including anthropometric measurement, range of motion, shoulder muscle strength assessment, inflammation test and questionnaires will be conducted.
- Conditions
- Arthroscopic Rotator Cuff Repair
- Being tested
- magnesium pin in additional to the suture anchor, routine suture anchor
- Keywords
- ARCR, Magnesium pin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium pin in additional to the suture anchorProcedure or surgery
magnesium pin in additional to the suture anchor used routinely in clinical practice
routine suture anchorProcedure or surgery
routine suture anchor for the treatment-as-usual
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention groups receives treated using magnesium pin in additional to the suture anchor used routinely in clinical practice. Receives: Procedure: magnesium pin in additional to the suture anchor |
| Control group | Active comparator | The control group receives routine suture anchor for the treatment-as-usual (TAU). Receives: Procedure: routine suture anchor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging Examinations
Upper extremity Magnetic resonance imaging (MRI) for study participants will be collected at Baseline, at 3, 6 and 12 months. The Baseline (pre-operative) MRI follows standard of care imaging and will not follow the study MRI Image Acquisition Protocol. The Baseline MRI must occur within 6 months of enrollment into this study. MRI at 3, 6- and 12-months post-surgery will be collected per Image Acquisition Protocol. Total tendon thickness (mm), tendon length (mm), size of retear (anteroposterior /mediolateral), and shape of retear will be recorded.
Measured: Baseline, post-operative 3 months, 6 months, and 12 months.
Cofield classification
The Cofield classification system will be used for all MRI analyses to assess the size of full-thickness tears(FTT) :
- Small = < 1 cm • Medium = 1-3 cm • Large = 3-5 cm • Massive = > 5 cm
Measured: Baseline, post-operative 3 months, 6 months, and 12 months.
Sugaya Score
The Sugaya score will be used to determine postoperative cuff integrity through magnetic resonance imaging classified into 5 categories: Type I to Type V. Type I indicates sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
Measured: Baseline, post-operative 3 months, 6 months, and 12 months.
Goutallier Classification
The Goutallier classification will be used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present . Grade 0: Completely normal muscle, without any fatty streaks, Grade 1: Some fatty streaks, Grade 2: Increased fatty infiltration, but more muscle than fat, Grade 3: Equal amounts of fat and muscle, Grade 4: more fat than muscle.
Measured: Baseline, post-operative 3 months, 6 months, and 12 months.
Secondary outcomes (20)
Height measurement
Height will be measured and report in meter.
Measured: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Weight measurement
Weight will be measured and report in kg.
Measured: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
BMI measurement
Weight and height will be measured and combined to report Body mass index (BMI) in kg/m^2.
Measured: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Shoulder flexibility (range of motion)
The passive range of shoulder flexion, shoulder abduction and shoulder internal and external rotation will be measured by a goniometer with the participant lying supine. Three measurements will be recorded and averaged for analysis.
Measured: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Shoulder muscle strength
The isometric force of shoulder internal and external rotation will be measured using a handheld dynamometer (HOGGAN Health Industries Inc, West Jordan, Utah). The subject will be asked to push against the examiner's resistance for 5 seconds. Three measurements will be recorded and averaged for analysis. The peak force will be normalized with the participant's body weight.
Measured: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Western Ontario Rotator Cuff (WORC) Index Western Ontario Rotator Cuff (WORC) Index Index
The WORC Index is a 21-item questionnaire assessing quality of life, evaluating the change in symptoms and functional ability, specific to rotator cuff tendinopathy; it is often used to compare pre-and postoperative changes in patients with a clinical diagnosis of an impingement syndrome, rotator cuff tendinopathy as well as arthroscopic rotator cuff repairs (ARCR).Raw scores range from 0 to 2100, with a higher score indicating decreased quality of life because of pathological condition of the rotator cuff.
Measured: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Constant-Murley Score
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The test is divided into four subscales: pain, activities of daily living, strength and range of motion (forward elevation, external rotation, abduction and internal rotation of the shoulder. The subjective findings (severity of pain, activities of daily living and working in different positions) comprise 35 points and the objective (examiner-assessed) measurements (arm range of motion without pain, measurements of exo- and endorotation via reference points and measuring muscle strength) comprise the remaining 65 points, for a total of 100 points.
Measured: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Visual Analogue Scale (VAS)
Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable.
Measured: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Adverse events
Any events related to the surgery will be recorded.
Measured: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
C-reactive protein measurement
5 ml blood samples will be collected and analysied for C-reactive protein measurement using a commercially available an enzyme-linked immunosorbent assay (ELISA) kit.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Calcium (Ca) measurement
The measurements of calcium (Ca) will be taken to monitor potential effect of magnesium pin.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Magnesium (Mg) measurement
The measurements of Mg will be taken to monitor potential effect of magnesium pin.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Phosphorous (P) measurement
The measurements of phosphorous will be taken to monitor potential effect of magnesium pin.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Creatinine (Cr) measurement
The measurements of Cr will be taken to monitor potential effect of magnesium pin.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Urea measurement
The measurements of urea will be taken to monitor potential effect of magnesium pin.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Alanine transaminase (ALT) measurement
The measurements of ALT will be taken to monitor potential effect of magnesium pin.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Aspartate aminotransferase (AST) measurement
The measurements of AST will be taken to monitor potential effect of magnesium pin.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Total protein (TP) measurement
The measurements of TP will be taken to monitor potential effect of magnesium pin.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Albumin (ALB) measurement
The measurements of ALB will be taken to monitor potential effect of magnesium pin.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Globulin (GLB) measurement
The measurements of GLB will be taken to monitor potential effect of magnesium pin.
Measured: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Rotator Cuff RepairStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292754
- Sponsor's protocol ID
- 2023.211
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Rotator Cuff Repair With Biodegradable Magnesium Pin: From Bench Side to Bedside
- ClinicalTrials.gov ID
- NCT06292754
- Acronym / sponsor ID
- 2023.211
- Conditions
- Arthroscopic Rotator Cuff Repair
- Keywords
- ARCR, Magnesium pin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Mar 2024 (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.
Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Arthroscopic rotator cuff repair (ARCR) is a surgical procedure to reattach the torn edge of the tendon to the underlying bone, which can improve the clinical symptoms of patients. However, the retear rate after arthroscopic repair is as high as 94% (1). The high re-tear rate following cuff repair is due to the lack of a strong tendon to bone integration. The natural healing responses after surgical reattachment are too weak to regenerate strong tendon insertion, primarily owing to insufficient osteogenesis. To enhance the bone-tendon interface (BTI) healing, the investigators have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.This study is a single-center, randomized controlled trial to investigate the effect of using magnesium pin as a suture to augment rotator cuff repair. The intervention groups receives treated using magnesium pin additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). The investigators hypothesize the magnesium pin applied in arthroscopic rotator cuff tears can promote BTI healing and reduce the cumulative retear rate with better functional outcomes.
Detailed description
Mechanical enhancement is a direct approach to enhance the bone-tendon interface (BTI) healing, which includes surgical techniques that seek to improve BTI healing through better fixation device. Favourable results would be achieved in the non-massively torn cases, improvement in the structural integrity and shoulder function were reported in the clinical studies. However, despite the improved initial biomechanical strength, high retear rate were still reported among the massive-teared patients, which indicates that enhancing the mechanical enhancement alone may not enough to promote the overall healing outcome. Other novel adjuvants to aid rotator cuff healing to promote bone tendon junction healing include growth factor supplementation, stem cells or biophysical intervention (5,6,7).
Tissue engineering is a promising strategy that would combine modern engineering techniques with novel biomaterials, cell therapy, growth factors, bioactive molecular. Enhancement of BTI healing with biomaterial, such as magnesium, may promote osteogenesis and thus improve the surgical outcome. These various approaches have been investigated in pre-clinical animal models of rotator cuff repair, yet further investigation to translate these into clinical practice is needed (8).
We have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.
The use of biodegradable materials as implants to stimulate healing has been developed in orthopaedics for decades. Our team and others reported that Mg-based interference screw or suture anchors could upregulate the expression of osteogenic and angiogenic factors experimentally, yet further investigation is still required to translate into clinical practice. However, the potential insufficient mechanical strength of Mg-based implants over the degradation period may result in a loss of fixation or failure of repair, which limits its clinical application. Herein, our novel magnesium pin showed good mechanical properties to be used to enhance the suture anchor commonly used for RCT repair in clinical practice. This can incorporate the benefit of an Mg-based component for its degradation and release of osteogenic and angiogenic by-products, but without the risk of compromising the integrity of the RCT repair site or the potentially osteoporotic bone at the repair site.
40 patients with rotator cuff tear scheduled for arthroscopic rotator cuff repair (ARCR) will be recruited from the Li Ka Shing Orthopaedic Specialist clinic at the Prince of Wales Hospital (PWH) Hong Kong.
Oral and written consents will be obtained from individuals who agree to participate in the study.
The recruitment period will last for 12 months and the whole project period is 2 years in total. Basic demographics, MRI assessment and Outcome Measurement Questionnaires will be carried out.
The intervention groups receive treated using magnesium pin in additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). Both treatments are conducted in clinical practices that are randomly allocated to either the intervention or the control condition. Participants are therefore randomized as their allocation depends on their practice being an intervention or a control practice.
Assessments including anthropometric measurement, range of motion, shoulder muscle strength assessment, inflammation test and questionnaires will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: magnesium pin in additional to the suture anchorThe intervention groups receives treated using magnesium pin in additional to the suture anchor used routinely in clinical practice. |
| Control group | Active comparator | Procedure: routine suture anchorThe control group receives routine suture anchor for the treatment-as-usual (TAU). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject requires Arthroscopic rotator cuff repair (ARCR) and amenable to repair.
- Subject is > 40 years of age (no upper limit);
- Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;
- Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
Key exclusion criteria (14 listed)
- Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
- Subjects with Samilson-Prieto osteoarthritis > 2;
- Subjects with current or prior infection of the ipsilateral shoulder;
- Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;
- Subjects with prior shoulder surgery (not including rotator cuff repair (revision repair subject group only), biceps tenodesis/tenotomy, distal clavicle excision (DCE), ubacromial decompression);
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 |
|---|---|---|
| magnesium pin in additional to the suture anchormagnesium pin in additional to the suture anchor used routinely in clinical practice | Procedure or surgery | Intervention group |
| routine suture anchorroutine suture anchor for the treatment-as-usual | Procedure or surgery | Control group |
Primary outcome
Imaging Examinations
Time frame: Baseline, post-operative 3 months, 6 months, and 12 months.
Upper extremity Magnetic resonance imaging (MRI) for study participants will be collected at Baseline, at 3, 6 and 12 months. The Baseline (pre-operative) MRI follows standard of care imaging and will not follow the study MRI Image Acquisition Protocol. The Baseline MRI must occur within 6 months of enrollment into this study. MRI at 3, 6- and 12-months post-surgery will be collected per Image Acquisition Protocol. Total tendon thickness (mm), tendon length (mm), size of retear (anteroposterior /mediolateral), and shape of retear will be recorded.
Cofield classification
Time frame: Baseline, post-operative 3 months, 6 months, and 12 months.
The Cofield classification system will be used for all MRI analyses to assess the size of full-thickness tears(FTT) : • Small = < 1 cm • Medium = 1-3 cm • Large = 3-5 cm • Massive = > 5 cm
Sugaya Score
Time frame: Baseline, post-operative 3 months, 6 months, and 12 months.
The Sugaya score will be used to determine postoperative cuff integrity through magnetic resonance imaging classified into 5 categories: Type I to Type V. Type I indicates sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
Goutallier Classification
Time frame: Baseline, post-operative 3 months, 6 months, and 12 months.
The Goutallier classification will be used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present . Grade 0: Completely normal muscle, without any fatty streaks, Grade 1: Some fatty streaks, Grade 2: Increased fatty infiltration, but more muscle than fat, Grade 3: Equal amounts of fat and muscle, Grade 4: more fat than muscle.
20 secondary outcomes
Height measurement
Time frame: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Weight measurement
Time frame: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
BMI measurement
Time frame: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Shoulder flexibility (range of motion)
Time frame: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Shoulder muscle strength
Time frame: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Western Ontario Rotator Cuff (WORC) Index Western Ontario Rotator Cuff (WORC) Index Index
Time frame: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Constant-Murley Score
Time frame: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Visual Analogue Scale (VAS)
Time frame: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
Adverse events
Time frame: baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.
C-reactive protein measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Calcium (Ca) measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Magnesium (Mg) measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Phosphorous (P) measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Creatinine (Cr) measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Urea measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Alanine transaminase (ALT) measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Aspartate aminotransferase (AST) measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Total protein (TP) measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Albumin (ALB) measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
Globulin (GLB) measurement
Time frame: baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively
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 5 Mar 2024.
- Individual participant dataSharing planned: Yes
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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 magnesium pin in additional to the suture anchor and routine suture anchor in people with Arthroscopic Rotator Cuff Repair, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 14 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: opening soon, as of the sponsor's last update on 5 Mar 2024. 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 Hong Kong. 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?
Contact Michael Tim-Yun ONG (55699059, michael.ong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging Examinations (time frame: Baseline, post-operative 3 months, 6 months, and 12 months.). The study lists 4 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 5 Mar 2024.