NCT04288570: Punch/Drill

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

Completed NA Results posted Last updated 8 April 2025

What this trial tests

NA trial testing suture anchor socket creation with punch in Rotator Cuff Tears in 43 participants. Completed in 1 July 2023.

Timeline

1 April 2020

Primary endpoint
15 June 2023

1 July 2023

Quick facts

Lead sponsor	Matt Smith
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	1 April 2020
Primary completion	15 June 2023
Estimated completion	1 July 2023
Sites	1 location across United States

Drugs / interventions tested

• suture anchor socket creation with punch
• suture anchor socket creation with drill

Conditions studied

• Rotator Cuff Tears — all drugs for Rotator Cuff Tears →

Sponsor

Matt Smith

Who can join

Adults 18 to 80, any sex, with Rotator Cuff Tears. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form Primary · 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).

Preop

Group	Value	95% CI
Bone Socket Formation With a Punch	41.51	± 2.22
Bone Socket Formation With a Drill	40.54	± 2.24

2 Weeks

Group	Value	95% CI
Bone Socket Formation With a Punch	36.81	± 2.42
Bone Socket Formation With a Drill	32.16	± 2.58

6 Weeks

Group	Value	95% CI
Bone Socket Formation With a Punch	42.74	± 2.42
Bone Socket Formation With a Drill	37.90	± 2.52

3 Months

Group	Value	95% CI
Bone Socket Formation With a Punch	44.41	± 2.23
Bone Socket Formation With a Drill	42.22	± 2.24

6 Months

Group	Value	95% CI
Bone Socket Formation With a Punch	46.90	± 2.52
Bone Socket Formation With a Drill	46.31	± 2.31

Single Assessment Numeric Evaluation (SANE) Primary · 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.

PreOp

Group	Value	95% CI
Bone Socket Formation With a Punch	35.86	± 17.22
Bone Socket Formation With a Drill	32.14	± 21.76

2 Weeks

Group	Value	95% CI
Bone Socket Formation With a Punch	22.0	± 22.67
Bone Socket Formation With a Drill	17.06	± 22.10

6 Weeks

Group	Value	95% CI
Bone Socket Formation With a Punch	35	± 29.53
Bone Socket Formation With a Drill	22.5	± 14.62

3 Months

Group	Value	95% CI
Bone Socket Formation With a Punch	38.83	± 25.14
Bone Socket Formation With a Drill	47.2	± 24.27

6 Months

Group	Value	95% CI
Bone Socket Formation With a Punch	68.36	± 31.63
Bone Socket Formation With a Drill	76.23	± 20.67

Visual Analogue Scale Primary · 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

Preop

Group	Value	95% CI
Bone Socket Formation With a Punch	4.86	± 2.01
Bone Socket Formation With a Drill	4.95	± 2.48

2 Weeks

Group	Value	95% CI
Bone Socket Formation With a Punch	1.14	± 1.46
Bone Socket Formation With a Drill	3.56	± 2.83

6 Weeks

Group	Value	95% CI
Bone Socket Formation With a Punch	1.78	± 1.62
Bone Socket Formation With a Drill	2.11	± 2.51

3 Months

Group	Value	95% CI
Bone Socket Formation With a Punch	2.06	± 1.84
Bone Socket Formation With a Drill	2.33	± 1.96

6 Months

Group	Value	95% CI
Bone Socket Formation With a Punch	2.64	± 2.42
Bone Socket Formation With a Drill	2.54	± 2.50

PROMIS - Pain Interference Primary · 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).

Preop

Group	Value	95% CI
Bone Socket Formation With a Punch	62.23	± 1.74
Bone Socket Formation With a Drill	63.11	± 1.84

2 Weeks

Group	Value	95% CI
Bone Socket Formation With a Punch	54.76	± 1.95
Bone Socket Formation With a Drill	61.66	± 2.43

6 Weeks

Group	Value	95% CI
Bone Socket Formation With a Punch	55.02	± 1.98
Bone Socket Formation With a Drill	58.52	± 2.58

3 Months

Group	Value	95% CI
Bone Socket Formation With a Punch	55.51	± 1.93
Bone Socket Formation With a Drill	56.83	± 2.03

6 Months

Group	Value	95% CI
Bone Socket Formation With a Punch	54.20	± 3.0
Bone Socket Formation With a Drill	54.27	± 2.55

Magnetic Resonance Imaging (MRI) of the Shoulder Secondary · 2 weeks

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)

Group	Value	95% CI
Bone Socket Formation With a Punch	20.4	11.8 – 29.4
Bone Socket Formation With a Drill	21.7	12.7 – 33.3

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.