Trial Outcomes & Findings for Suture Anchor Comparison in Rotator Cuff Repairs (NCT NCT02350647)

Last Updated: 2021-01-13

Results Overview

The ossification quality score is an ordinal measure of quality of bone reabsorption that is divided into four progressive groups. Quality score 1 reflects "little or no bone ossification", Quality score 2 reflects "Some ossification; discontinuous or with a wide lucent rim", Quality score 3 reflects "Ossification with a thin lucent rim", and Quality score 4 reflects "Good ossification; border of tract vague". For this study, Quality scores 1 and 2 will be merged (defined as low quality ossification) as will Quality scores 3 and 4 (defined as high quality ossification). The proportion of suture anchors graded as having high quality ossification versus low quality ossification will be compared between the two groups to determine if there is a significant difference between Healicoil and Twinfix anchors in regards to quality of ossification.

Recruitment status

COMPLETED

Study phase

Target enrollment

64 participants

Primary outcome timeframe

2 years

Results posted on

2021-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	HEALICOIL Regenesorb Suture anchor for rotator cuff repair Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors	Twinfix Ultra HA Suture anchor for rotator cuff repair Suture anchor Twinfix Ultra HA
Overall Study STARTED	32	32
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Suture Anchor Comparison in Rotator Cuff Repairs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HEALICOIL Regenesorb n=32 Participants Suture anchor for rotator cuff repair Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors	Twinfix Ultra HA n=32 Participants Suture anchor for rotator cuff repair Suture anchor Twinfix Ultra HA	Total n=64 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	57 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: The Ossification Quality Score will be assessed for each anchor implanted into a study subjects' shoulder. Because many subjects have more than one rotator cuff suture anchor implanted, the overall number of units analyzed will be greater than the overall number of participants analyzed.

Outcome measures

Outcome measures
Measure	HEALICOIL Regenesorb n=57 Suture Anchors Suture anchor for rotator cuff repair Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors	Twinfix Ultra HA n=60 Suture Anchors Suture anchor for rotator cuff repair Suture anchor Twinfix Ultra HA
Ossification Quality Score (Bony Ingrowth Assessed Via CT) Number of High Quality Ossification Anchors	42 Suture Anchors	36 Suture Anchors
Ossification Quality Score (Bony Ingrowth Assessed Via CT) Number of Low Quality Ossification Anchors	15 Suture Anchors	24 Suture Anchors

SECONDARY outcome

Timeframe: 6 months

Repair failure rate (Defined as number of subjects with a re-tear) determined by ultrasound 6 months after surgery.

Outcome measures

Outcome measures
Measure	HEALICOIL Regenesorb n=26 Participants Suture anchor for rotator cuff repair Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors	Twinfix Ultra HA n=26 Participants Suture anchor for rotator cuff repair Suture anchor Twinfix Ultra HA
Number of Participants With a Rotator Cuff Re-tear	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 2 years

The Visual Analogue Pain Scale (VAS) measures the patient-reported level of pain at the two-year follow-up. The scale runs from 0 to 10, with "0" indicating no pain and "10" indicating extreme pain. The lower the VAS Pain level, the better the outcome in regards to level of pain.

Outcome measures

Outcome measures
Measure	HEALICOIL Regenesorb n=26 Participants Suture anchor for rotator cuff repair Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors	Twinfix Ultra HA n=26 Participants Suture anchor for rotator cuff repair Suture anchor Twinfix Ultra HA
Visual Analogue Pain Scale	1.2 score on a scale Standard Deviation 1.3	1.8 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 2 years

Outcomes at Two Years on the following: * Western Ontario Rotator Cuff Index (WORC): developed to help understand the particular signs, symptoms, and functional limitations associated with rotator cuff tendinopathy. The outcome is measured on a scale of 0 to 100, with 100 being the best outcome and 0 being the worst. * PENN Shoulder Score (PENN): The PENN is a 100-point shoulder-specific self-report questionnaire evaluating pain, satisfaction, and shoulder function. The outcome is measured on a scale of 0 to 100, with 100 being the best outcome and 0 being the worst. * Single Assessment Numeric Evaluation (SANE): A single question that asks "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?" 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder. * Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating "The best health you can imagine" and

Outcome measures

Outcome measures
Measure	HEALICOIL Regenesorb n=26 Participants Suture anchor for rotator cuff repair Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors	Twinfix Ultra HA n=26 Participants Suture anchor for rotator cuff repair Suture anchor Twinfix Ultra HA
Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) SANE	84.2 score on a scale Standard Deviation 20.9	86.7 score on a scale Standard Deviation 13.9
Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) WORC	78.7 score on a scale Standard Deviation 25.2	84.6 score on a scale Standard Deviation 13.5
Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) PENN	88.0 score on a scale Standard Deviation 13.6	88.6 score on a scale Standard Deviation 10.4
Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) EQ-5D	83.3 score on a scale Standard Deviation 16.3	87.3 score on a scale Standard Deviation 7.4

Adverse Events

HEALICOIL Regenesorb

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Twinfix Ultra HA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HEALICOIL Regenesorb n=26 participants at risk Suture anchor for rotator cuff repair Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors	Twinfix Ultra HA n=26 participants at risk Suture anchor for rotator cuff repair Suture anchor Twinfix Ultra HA
Surgical and medical procedures Loose biceps suture anchor	0.00% 0/26 • Adverse events were collected and assessed from time of surgery to two year final study follow-up	3.8% 1/26 • Number of events 1 • Adverse events were collected and assessed from time of surgery to two year final study follow-up

Additional Information

Kyle Adams, Research Coordinator

Hawkins Foundation

Phone: 864-454-7458

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place