Trial Outcomes & Findings for Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain (NCT NCT04288570)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months

Results posted on

2025-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Bone Socket Formation With a Punch suture anchor socket creation with punch suture anchor socket creation with punch: suture anchor socket creation with punch	Bone Socket Formation With a Drill suture anchor socket creation with drill suture anchor socket creation with drill: suture anchor socket creation with drill
Overall Study STARTED	21	22
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bone Socket Formation With a Punch n=21 Participants suture anchor socket creation with punch suture anchor socket creation with punch: suture anchor socket creation with punch	Bone Socket Formation With a Drill n=22 Participants suture anchor socket creation with drill suture anchor socket creation with drill: suture anchor socket creation with drill	Total n=43 Participants Total of all reporting groups
Age, Continuous	61.4 years n=99 Participants	59.3 years n=107 Participants	60.3 years n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	12 Participants n=107 Participants	19 Participants n=206 Participants
Sex: Female, Male Male	14 Participants n=99 Participants	10 Participants n=107 Participants	24 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants	18 Participants n=107 Participants	39 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Bone Socket Formation With a Punch n=21 Participants suture anchor socket creation with punch suture anchor socket creation with punch: suture anchor socket creation with punch	Bone Socket Formation With a Drill n=22 Participants suture anchor socket creation with drill suture anchor socket creation with drill: suture anchor socket creation with drill
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form Preop	41.51 T-Score Standard Deviation 2.22	40.54 T-Score Standard Deviation 2.24
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form 2 Weeks	36.81 T-Score Standard Deviation 2.42	32.16 T-Score Standard Deviation 2.58
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form 6 Weeks	42.74 T-Score Standard Deviation 2.42	37.90 T-Score Standard Deviation 2.52
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form 3 Months	44.41 T-Score Standard Deviation 2.23	42.22 T-Score Standard Deviation 2.24
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form 6 Months	46.90 T-Score Standard Deviation 2.52	46.31 T-Score Standard Deviation 2.31

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bone Socket Formation With a Punch n=21 Participants suture anchor socket creation with punch suture anchor socket creation with punch: suture anchor socket creation with punch	Bone Socket Formation With a Drill n=22 Participants suture anchor socket creation with drill suture anchor socket creation with drill: suture anchor socket creation with drill
Single Assessment Numeric Evaluation (SANE) PreOp	35.86 score on a scale Standard Deviation 17.22	32.14 score on a scale Standard Deviation 21.76
Single Assessment Numeric Evaluation (SANE) 2 Weeks	22.0 score on a scale Standard Deviation 22.67	17.06 score on a scale Standard Deviation 22.10
Single Assessment Numeric Evaluation (SANE) 6 Weeks	35 score on a scale Standard Deviation 29.53	22.5 score on a scale Standard Deviation 14.62
Single Assessment Numeric Evaluation (SANE) 3 Months	38.83 score on a scale Standard Deviation 25.14	47.2 score on a scale Standard Deviation 24.27
Single Assessment Numeric Evaluation (SANE) 6 Months	68.36 score on a scale Standard Deviation 31.63	76.23 score on a scale Standard Deviation 20.67

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Bone Socket Formation With a Punch n=21 Participants suture anchor socket creation with punch suture anchor socket creation with punch: suture anchor socket creation with punch	Bone Socket Formation With a Drill n=22 Participants suture anchor socket creation with drill suture anchor socket creation with drill: suture anchor socket creation with drill
Visual Analogue Scale Preop	4.86 score on a scale Standard Deviation 2.01	4.95 score on a scale Standard Deviation 2.48
Visual Analogue Scale 2 Weeks	1.14 score on a scale Standard Deviation 1.46	3.56 score on a scale Standard Deviation 2.83
Visual Analogue Scale 6 Weeks	1.78 score on a scale Standard Deviation 1.62	2.11 score on a scale Standard Deviation 2.51
Visual Analogue Scale 3 Months	2.06 score on a scale Standard Deviation 1.84	2.33 score on a scale Standard Deviation 1.96
Visual Analogue Scale 6 Months	2.64 score on a scale Standard Deviation 2.42	2.54 score on a scale Standard Deviation 2.50

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Bone Socket Formation With a Punch n=21 Participants suture anchor socket creation with punch suture anchor socket creation with punch: suture anchor socket creation with punch	Bone Socket Formation With a Drill n=22 Participants suture anchor socket creation with drill suture anchor socket creation with drill: suture anchor socket creation with drill
PROMIS - Pain Interference Preop	62.23 T-Score Standard Deviation 1.74	63.11 T-Score Standard Deviation 1.84
PROMIS - Pain Interference 2 Weeks	54.76 T-Score Standard Deviation 1.95	61.66 T-Score Standard Deviation 2.43
PROMIS - Pain Interference 6 Weeks	55.02 T-Score Standard Deviation 1.98	58.52 T-Score Standard Deviation 2.58
PROMIS - Pain Interference 3 Months	55.51 T-Score Standard Deviation 1.93	56.83 T-Score Standard Deviation 2.03
PROMIS - Pain Interference 6 Months	54.20 T-Score Standard Deviation 3.0	54.27 T-Score Standard Deviation 2.55

SECONDARY outcome

Timeframe: 2 weeks

Population: The analysis population include all participants that completed the MRI at the 2 week post-op evaluation.

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)

Outcome measures

Outcome measures
Measure	Bone Socket Formation With a Punch n=5 Participants suture anchor socket creation with punch suture anchor socket creation with punch: suture anchor socket creation with punch	Bone Socket Formation With a Drill n=4 Participants suture anchor socket creation with drill suture anchor socket creation with drill: suture anchor socket creation with drill
Magnetic Resonance Imaging (MRI) of the Shoulder	20.4 mm^2 Interval 11.8 to 29.4	21.7 mm^2 Interval 12.7 to 33.3

Adverse Events

Bone Socket Formation With a Punch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bone Socket Formation With a Drill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vicki L Jones

UMissouri

Phone: 573-882-7583

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place