Rotator Cuff TearsPunch/DrillNCT04288570

Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain

A study testing suture anchor socket creation with punch and suture anchor socket creation with drill in people with Rotator Cuff Tears, run by Matt Smith at 1 site in United States.

Completed

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

Official record

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Trial summary

To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Rotator Cuff Tears
What is being tested?: suture anchor socket creation with punch and suture anchor socket creation with drill
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2020to 1 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient's aged 18-80 years old with diagnosis of rotator cuff tear having failed non-operative management and being indicated for surgical intervention with use of suture anchors.

Who cannot join

Glenohumeral arthrosis
Previous shoulder surgery
Psychiatric diseasesMRI
Rheumatologic diseases
Fibromyalgia
Spine diseases

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Missouri
Columbia, Missouri, 65212

Other trials in United States

About this study

To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair.

Conditions: Rotator Cuff Tears
Being tested: suture anchor socket creation with punch, suture anchor socket creation with drill
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.

suture anchor socket creation with punchProcedure or surgery
suture anchor socket creation with punch
suture anchor socket creation with drillProcedure or surgery
suture anchor socket creation with drill

Study groups in NCT04288570
Study group	Role	What they receive
Bone socket formation with a punch	Active comparator	suture anchor socket creation with punch Receives: Procedure: suture anchor socket creation with punch
Bone socket formation with a drill	Active comparator	suture anchor socket creation with drill Receives: Procedure: suture anchor socket creation with drill

What is being measured

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

Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form
The PROMIS Physical Function Short Form uses T-scores (Mean = 50, SD = 10), where higher scores indicate better physical function. Responses use a Likert scale: 1 = "Unable to do," 2 = "With much difficulty," 3 = "With some difficulty," 4 = "With a little difficulty," 5 = "Without any difficulty." Raw scores are summed and converted to T-scores. 50 = average function, 60 = 1 SD above (better), 40 = 1 SD below (worse).
Measured: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
Single Assessment Numeric Evaluation (SANE)
The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measure. A SANE score requires the patient to rate their knee function on a scale of 0 to 100% with 100% being normal.
Measured: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
Visual Analogue Scale
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
Measured: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
PROMIS - Pain Interference
The PROMIS Pain Interference Short Form uses T-scores (Mean = 50, SD = 10), where higher scores indicate greater pain interference. Responses use a Likert scale: 1 = "Not at all," 2 = "A little bit," 3 = "Somewhat," 4 = "Quite a bit," 5 = "Very much." Raw scores are summed and converted to T-scores. 50 = average pain interference, 60 = 1 SD above (worse), 40 = 1 SD below (better).
Measured: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months

Secondary outcomes (1)

Magnetic Resonance Imaging (MRI) of the Shoulder
MRI of the shoulder of the first 5 patients in each group will be obtained at 2 weeks post-op for evaluation of bone marrow lesion in the proximal humerus. Bone marrow lesion size measured in mm2 on a calibrated MR image from 0 (no lesion, better) to 180 (large lesion, worse)
Measured: 2 weeks

Timeline

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

1 Apr 20201 Jul 2023

First posted28 Feb 2020
Study start1 Apr 2020
Primary completion15 Jun 2023
Study completion1 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04288570
Sponsor's protocol ID: 2019842
Acronym: Punch/Drill
Status last verified: Apr 2025
First submitted: 20 Feb 2020
Last updated: 8 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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

Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears

All Rotator Cuff Tears trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain
ClinicalTrials.gov ID: NCT04288570
Acronym / sponsor ID: Punch/Drill / 2019842
Conditions: Rotator Cuff Tears
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Matt SmithUniversity, hospital or other
Study start: 1 Apr 2020 (actual)
Primary completion: 15 Jun 2023 (actual)
Study completion: 1 Jul 2023 (actual)
First posted: 28 Feb 2020 (actual)
Results: Posted 8 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bone socket formation with a punch	Active comparator	Procedure: suture anchor socket creation with punchsuture anchor socket creation with punch
Bone socket formation with a drill	Active comparator	Procedure: suture anchor socket creation with drillsuture anchor socket creation with drill

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patient's aged 18-80 years old with diagnosis of rotator cuff tear having failed non-operative management and being indicated for surgical intervention with use of suture anchors.

Key exclusion criteria (6 listed)

Glenohumeral arthrosis
Previous shoulder surgery
Psychiatric diseasesMRI
Rheumatologic diseases
Fibromyalgia

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
suture anchor socket creation with punchsuture anchor socket creation with punch	Procedure or surgery	Bone socket formation with a punch
suture anchor socket creation with drillsuture anchor socket creation with drill	Procedure or surgery	Bone socket formation with a drill

Primary outcome

Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form
Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
The PROMIS Physical Function Short Form uses T-scores (Mean = 50, SD = 10), where higher scores indicate better physical function. Responses use a Likert scale: 1 = "Unable to do," 2 = "With much difficulty," 3 = "With some difficulty," 4 = "With a little difficulty," 5 = "Without any difficulty." Raw scores are summed and converted to T-scores. 50 = average function, 60 = 1 SD above (better), 40 = 1 SD below (worse).
Single Assessment Numeric Evaluation (SANE)
Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measure. A SANE score requires the patient to rate their knee function on a scale of 0 to 100% with 100% being normal.
Visual Analogue Scale
Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
PROMIS - Pain Interference
Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
The PROMIS Pain Interference Short Form uses T-scores (Mean = 50, SD = 10), where higher scores indicate greater pain interference. Responses use a Likert scale: 1 = "Not at all," 2 = "A little bit," 3 = "Somewhat," 4 = "Quite a bit," 5 = "Very much." Raw scores are summed and converted to T-scores. 50 = average pain interference, 60 = 1 SD above (worse), 40 = 1 SD below (better).

1 secondary outcome

Magnetic Resonance Imaging (MRI) of the Shoulder
Time frame: 2 weeks

Results and safety

Results posted to the registry on 8 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bone Socket Formation With a Punch	21	21
Bone Socket Formation With a Drill	22	22

Primary outcome: Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form

Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months. Mean (Standard Deviation). Unit: T-Score

Measure	Bone Socket Formation With a Punch n = 21	Bone Socket Formation With a Drill n = 22
Preop	41.51 (2.22)	40.54 (2.24)
2 Weeks	36.81 (2.42)	32.16 (2.58)
6 Weeks	42.74 (2.42)	37.90 (2.52)
3 Months	44.41 (2.23)	42.22 (2.24)
6 Months	46.90 (2.52)	46.31 (2.31)

Primary outcome: Single Assessment Numeric Evaluation (SANE)

Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months. Mean (Standard Deviation). Unit: score on a scale

Measure	Bone Socket Formation With a Punch n = 21	Bone Socket Formation With a Drill n = 22
PreOp	35.86 (17.22)	32.14 (21.76)
2 Weeks	22.0 (22.67)	17.06 (22.10)
6 Weeks	35 (29.53)	22.5 (14.62)
3 Months	38.83 (25.14)	47.2 (24.27)
6 Months	68.36 (31.63)	76.23 (20.67)

Primary outcome: Visual Analogue Scale

Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months. Mean (Standard Deviation). Unit: score on a scale

Measure	Bone Socket Formation With a Punch n = 21	Bone Socket Formation With a Drill n = 22
Preop	4.86 (2.01)	4.95 (2.48)
2 Weeks	1.14 (1.46)	3.56 (2.83)
6 Weeks	1.78 (1.62)	2.11 (2.51)
3 Months	2.06 (1.84)	2.33 (1.96)
6 Months	2.64 (2.42)	2.54 (2.50)

Primary outcome: PROMIS - Pain Interference

Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months. Mean (Standard Deviation). Unit: T-Score

Measure	Bone Socket Formation With a Punch n = 21	Bone Socket Formation With a Drill n = 22
Preop	62.23 (1.74)	63.11 (1.84)
2 Weeks	54.76 (1.95)	61.66 (2.43)
6 Weeks	55.02 (1.98)	58.52 (2.58)
3 Months	55.51 (1.93)	56.83 (2.03)
6 Months	54.20 (3.0)	54.27 (2.55)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bone Socket Formation With a Punch	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Bone Socket Formation With a Drill	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Limitations and caveats (from the sponsor): A limitation of our study was that the surgeon was not blinded to the intervention given that surgical technique was the variable in question for the study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rotator Cuff Tears

Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears

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.

Matthew J Smith principal investigator

University of Missouri Health System, Department of Orthopaedic Surgery

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

Questions about this trial

What is this clinical trial studying?

A study testing suture anchor socket creation with punch and suture anchor socket creation with drill in people with Rotator Cuff Tears, run by Matt Smith at 1 site in United States.

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 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 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 United States. 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?

Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form (time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 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?

On the ClinicalTrials.gov record for NCT04288570.

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 8 Apr 2025.