ArthroscopyQ-FixNCT03765515

A Clinical Study to Evaluate the Safety and Efficacy of Q-Fix Trial in Chinese Patients

A study testing Twinfix Ti and Q-Fix in people with Arthroscopy, run by Smith & Nephew, Inc. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Protocol synopsis Title of Study: A Prospective, Randomized, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of Q-Fix All-Suture Anchor in Arthroscopic Repair of Shoulder Soft Tissue in Chinese Patients Study Design: Prospective, multicenter, comparative, randomized, concurrent control Study Type… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Arthroscopy
What is being tested?: Twinfix Ti and Q-Fix
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 4 sitesChina
Study dates: 12 Apr 2019to 12 Apr 2021
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects, aged 18 - 75 years (inclusive at both ends), only of Chinese ethnicity.
Patients with mature bones;
Patients with rotator cuff tear and/or shoulder joint instability requiring arthroscopic treatment;
Patients who are able to give voluntary and written informed consent to participate in the study and have signed EC-approved informed consent form.
Patients who are able to understand this clinical study, co-operates with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups for up to 12 months.

Who cannot join

Patients suffering from the rheumatic arthritis, tuberculosis of shoulder joint and infection around the shoulder joint;
Patients with massive rotator cuff tear that can't be repaired;
Patients who have received the rotator cuff surgery, arthroplasty of shoulder or surgical treatment of fracture for the shoulder joint at investigational side;
Patients with a bone defect existing in the glenoid cavity that need the reconstruction of bony defect in the glenoid cavity;
Patients that plan to receive the surgery for bilateral shoulder joint during the study;
Patients suffering from the bone diseases with pathological characteristics, such as cystic changes or severe osteoporosis, that may affect the safe fixation of anchor in the investigator's opinion;

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Patients suffering from an active infection or sepsis (treated or untreated);
Patients suffering from other diseases (e.g. epilepsy) that may affect the results of shoulder joint function;
Patients that are known to be allergic to foreign body of materials of investigational product. If allergy to material is suspected, the corresponding test should be conducted and the possibility of allergy should be ruled out before implantation;
Patients suffering from serious cardiovascular disease, liver and kidney diseases;
Patients have an emotional or neurological condition that will affect their ability or willingness to participate in the study (e.g. cognitive disorder, mental illness, mental retardation).
Patients are immunosuppressed, have an autoimmune disorder, or an immune dysfunction. For examples, patients are on immunosuppressive therapy (cortisol at large dose, cytotoxic drugs, antilymphocytic serum or irradiation at large doses);
Patients are known to be at risk of being lost to follow-up, or failure to return to hospital for scheduled visits.
Patients participated in another clinical study of investigational drug, biologic, or device in the last 12 months.
Pregnant or lactating women, or those intend to become pregnant during the course of the study.
Known alcohol and/or drug abuse.
There are other serious or acute diseases, psychological conditions or social environment factors that may increase the risk of participating in the study or performing the surgery, or may reduce the reliability of participating in the study, or may increase the risk to the subjects themselves or others, in the investigator's opinion.

Trial locations and contacts

4 sites in 1 country.

China4 sites

Peking University Third Hospital
Beijing, 100191
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
Foshan Hospital of TCM
Foshan, Guangdong, 528000
2nd Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: A Prospective, Randomized, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of Q-Fix All-Suture Anchor in Arthroscopic Repair of Shoulder Soft Tissue in Chinese Patients

Study Design: Prospective, multicenter, comparative, randomized, concurrent control Study Type: Randomized Controlled Trial (RCT) Study Product: Q-Fix All-Suture Anchor Comparison Group Twinfix Ti Suture Anchor Study Purpose: The purpose of this study is to evaluate the safety and efficacy of Q-Fix All-suture Anchor in patients requiring the repair of soft tissue of shoulder who receive the arthroscopic repair of soft tissue using Q-Fix All-suture Anchor, when compared with the patients receiving the treatment with Twinfix Ti Suture Anchor. The result of this trial will be used for the Q-Fix All-suture Anchor registration in China.

Primary Objective: The primary objective of this study is to confirm that the clinical outcome of subjects receiving the treatment with Q-Fix All-suture Anchor is non-inferior to that of the subjects receiving the treatment with Twinfix Ti Suture Anchor during the same period, at 6 months after the repair of soft tissue of shoulder, taking the mean Constant score as efficacy endpoint.

Secondary Objective(s): The secondary objective of this study is to determine the safety and efficacy of Q-Fix All-suture Anchor at 12 months after repair of soft tissue of shoulder.

Statistical Rationale: The primary efficacy endpoint of this study is Constant score at 6 months after operation. The non-inferiority testing is performed for efficiency of primary efficacy endpoint; the test hypothesis is as follows:

Invalid hypothesis: H0: μ1-μ2 ≤ -δ Alternative hypothesis: H1: μ1-μ2 > -δ Where, μ1 and μ2 are the mean Constant scores in the test and control group, respectively. δ is the non-inferiority margin, which is set to 10. The hypothesis will be tested by two-sided t-test at the alpha level of α=0.025 (one-tailed test). the A non-inferior test will be conducted on the Constant scores in the test and control groups. The 95% confidence interval for the difference between two groups will be calculated. If the lower limit of 95%CI for the efficiency difference between two groups is greater than -9, it is considered that the test group is non-inferior to the control group.

Sample Size: 128 (64 in each group) Number of Study Sites: Approximate 5 clinical sites Targeted Global Regions: China

Read the detailed description

Study Duration: 24 months = 12 months of recruitment + 12 months of follow up (From the start of screening to the time that the last subject completes the trial) Primary endpoint: Constant score at 6 months after operation for the shoulder Secondary endpoint(s): ASES score Rowe score WORC questionnaire Incidence of rotator cuff re-tear Recurrence rate of shoulder joint instability Anchor pullout rate Adverse event Radiographic evaluation results Constant score Safety Data AEs, SAEs, ADEs, UADEs

Conditions: Arthroscopy
Being tested: Twinfix Ti, Q-Fix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Twinfix TiDevice
The purpose is to evaluate the safety and efficacy of Q-Fix in patients requiring the repair of soft tissue of shoulder who receive the arthroscopic repair of soft tissue using Q-Fix, when compared with the patients receiving the treatment with Twinfix Ti Suture Anchor. The result of this trial will be used for the Q-Fix All-suture Anchor registration in China.
Q-FixDevice
Q-Fix

Study groups in NCT03765515
Study group	Role	What they receive
Q-Fix	Experimental	Q-Fix has the advantages of all-suture implant and has the same or better performance than the traditional anchor. * Consistent activation effect * Excellent performance * Streamlined technique Q-fix is an experimental Arm. Receives: Device: Q-Fix
Twinfix Ti	Active comparator	The Smith \& Nephew's marketed Twinfix Suture Anchor is selected as the control product. This product is composed of anchor, suture, suture needle and inserter. The anchor is made of Ti6Al4V titanium alloy conforming to ISO5832-3. The Durabraid suture is made of polyester (Polyethylene terephthalate) conforming to YY 0167. Ultrabraid suture is made of two materials of UHMWPE and polypropylene monofilaments conforming to GB/T 19701.1. The suture needle is made of Type 420B stainless steel conforming to YY/T 0726. The stem portion of inserter that comes into contact with the body is made of Type 630B stainless steel conforming to YY/T 0726. Receives: Device: Twinfix Ti

What is being measured

The primary outcome is the main question the study is designed to answer.

The Constant-Murley score at 6 months after operation.
Confirming Q-Fix is non-inferior to Twinfix, at 6 months after the repair of soft The Constant score is a 100 points scale consisting of four variables, which includes a patient reported part (pain 15 points and activity level 20 points), which results in a total of 35 points. Next to this there is a physician rated part (shoulder strength 25 points and range of motion 40 points) which totals 65 points.
Measured: at 6 months after operation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 201912 Apr 2021

First posted5 Dec 2018
Study start12 Apr 2019
Primary completion28 Jun 2020
Study completion12 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ArthroscopyStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The 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
Model description: Randomized Controlled Trial (RCT)
Masking: None (open label)
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03765515
Sponsor's protocol ID: 17-5010-05
Acronym: Q-Fix
Status last verified: Aug 2021
First submitted: 4 Dec 2018
Last updated: 5 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arthroscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of Q-Fix All-Suture Anchor in Arthroscopic Repair of Shoulder Soft Tissue in Chinese Patients
ClinicalTrials.gov ID: NCT03765515
Acronym / sponsor ID: Q-Fix / 17-5010-05
Conditions: Arthroscopy
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 12 Apr 2019 (actual)
Primary completion: 28 Jun 2020 (actual)
Study completion: 12 Apr 2021 (actual)
First posted: 5 Dec 2018 (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.

Secondary Objective(s): The secondary objective of this study is to determine the safety and efficacy of Q-Fix All-suture Anchor at 12 months after repair of soft tissue of shoulder.

Sample Size: 128 (64 in each group) Number of Study Sites: Approximate 5 clinical sites Targeted Global Regions: China

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized Controlled Trial (RCT)

Arm	Type	Receives
Q-Fix	Experimental	Device: Q-FixQ-Fix has the advantages of all-suture implant and has the same or better performance than the traditional anchor. * Consistent activation effect * Excellent performance * Streamlined technique Q-fix is an experimental Arm.
Twinfix Ti	Active comparator	Device: Twinfix TiThe Smith \& Nephew's marketed Twinfix Suture Anchor is selected as the control product. This product is composed of anchor, suture, suture needle and inserter. The anchor is made of Ti6Al4V titanium alloy conforming to ISO5832-3. The Durabraid suture is made of polyester (Polyethylene terephthalate) conforming to YY 0167. Ultrabraid suture is made of two materials of UHMWPE and polypropylene monofilaments conforming to GB/T 19701.1. The suture needle is made of Type 420B stainless steel conforming to YY/T 0726. The stem portion of inserter that comes into contact with the body is made of Type 630B stainless steel conforming to YY/T 0726.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female subjects, aged 18 - 75 years (inclusive at both ends), only of Chinese ethnicity.
Patients with mature bones;
Patients with rotator cuff tear and/or shoulder joint instability requiring arthroscopic treatment;
Patients who are able to give voluntary and written informed consent to participate in the study and have signed EC-approved informed consent form.
Patients who are able to understand this clinical study, co-operates with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups for up to 12 months.

Key exclusion criteria (17 listed)

Patients suffering from the rheumatic arthritis, tuberculosis of shoulder joint and infection around the shoulder joint;
Patients with massive rotator cuff tear that can't be repaired;
Patients who have received the rotator cuff surgery, arthroplasty of shoulder or surgical treatment of fracture for the shoulder joint at investigational side;
Patients with a bone defect existing in the glenoid cavity that need the reconstruction of bony defect in the glenoid cavity;
Patients that plan to receive the surgery for bilateral shoulder joint during the study;

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
Twinfix TiThe purpose is to evaluate the safety and efficacy of Q-Fix in patients requiring the repair of soft tissue of shoulder who receive the arthroscopic repair of soft tissue using Q-Fix, when compared with the patients receiving the treatment with Twinfix Ti Suture Anchor. The result of this trial will be used for the Q-Fix All-suture Anchor registration in China.	Device	Twinfix Ti
Q-FixQ-Fix	Device	Q-Fix

Primary outcome

The Constant-Murley score at 6 months after operation.
Time frame: at 6 months after operation.
Confirming Q-Fix is non-inferior to Twinfix, at 6 months after the repair of soft The Constant score is a 100 points scale consisting of four variables, which includes a patient reported part (pain 15 points and activity level 20 points), which results in a total of 35 points. Next to this there is a physician rated part (shoulder strength 25 points and range of motion 40 points) which totals 65 points.

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 5 Aug 2021.
Individual participant dataSharing planned: No

Related trials for Arthroscopy

RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome
Recruiting
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
Postoperative Pain, Acute, Shoulder Pain
Not yet recruiting
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
Postoperative Pain

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.

Hui NA Yan, Doctor principal investigator

Peking University Third Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Twinfix Ti and Q-Fix in people with Arthroscopy, run by Smith & Nephew, Inc. at 4 sites in China.

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 17 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 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. 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?

The Constant-Murley score at 6 months after operation. (time frame: at 6 months after operation.). 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 NCT03765515.

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 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.