Trial Outcomes & Findings for A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair (NCT NCT01706978)

Results Overview

The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

176 participants

Primary outcome timeframe

From baseline to up until 24-Months Post-Operative

Results posted on

2020-09-18

Participant Flow

A number of participants who consented to be part of this study were withdrawn or excluded, prior to randomization due to study procedures not being able to be arranged pre-operatively for various reasons. A large number of participants were crossed over into another parallel study being run at The Ottawa Hospital.

Participant milestones

Participant milestones
Measure	Soft Tissue Trephination Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Soft Tissue Trephination	Bone Trephination Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Bone Trephination
Overall Study STARTED	47	41
Overall Study COMPLETED	38	35
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Soft Tissue Trephination n=47 Participants Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Soft Tissue Trephination	Bone Trephination n=41 Participants Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Bone Trephination	Total n=88 Participants Total of all reporting groups
Age, Continuous	59.5 years n=47 Participants	58.8 years n=41 Participants	59.2 years n=88 Participants
Sex: Female, Male Female	28 Participants n=47 Participants	28 Participants n=41 Participants	56 Participants n=88 Participants
Sex: Female, Male Male	19 Participants n=47 Participants	13 Participants n=41 Participants	32 Participants n=88 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	47 participants n=47 Participants	41 participants n=41 Participants	88 participants n=88 Participants
Hand Dominance Non-Dominant Arm Affected	20 Participants n=47 Participants	16 Participants n=41 Participants	36 Participants n=88 Participants
Hand Dominance Dominant Arm Affected	27 Participants n=47 Participants	25 Participants n=41 Participants	52 Participants n=88 Participants

PRIMARY outcome

Timeframe: From baseline to up until 24-Months Post-Operative

The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.

Outcome measures

Outcome measures
Measure	Soft Tissue Trephination n=38 Participants Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Soft Tissue Trephination	Bone Trephination n=35 Participants Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Bone Trephination
Western Ontario Rotator Cuff Index	82 score on a scale Standard Deviation 25	80 score on a scale Standard Deviation 21

SECONDARY outcome

Timeframe: From baseline to up until 24-Months Post-Operative

The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Soft Tissue Trephination n=38 Participants Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Soft Tissue Trephination	Bone Trephination n=35 Participants Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Bone Trephination
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores	85 score on a scale Standard Deviation 22	84 score on a scale Standard Deviation 17

SECONDARY outcome

Timeframe: From baseline to up until 24-Months Post-Operative

The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).

Outcome measures

Outcome measures
Measure	Soft Tissue Trephination n=38 Participants Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Soft Tissue Trephination	Bone Trephination n=35 Participants Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Bone Trephination
The Constant Score Total Score	81 score on a scale Standard Deviation 16	83 score on a scale Standard Deviation 12
The Constant Score Strength	15.9 score on a scale Standard Deviation 6.4	15.8 score on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: From surgery to up until 24-Months Post-Operative

Imaging parameters will be examined using ultrasound and magnetic resonance imaging (MRI). These images will be analyzed to determine healing status of the tissues post-operatively. Imaging will determine whether the tissue is healed, partially torn, or fully torn after surgery. Higher incidence of tearing will be compared between groups. A higher incidence of tearing indicates worse outcomes.

Outcome measures

Outcome measures
Measure	Soft Tissue Trephination n=39 Participants Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Soft Tissue Trephination	Bone Trephination n=36 Participants Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Bone Trephination
Healing Rates Percentage of Participants Healed	87 percentage of participants	75 percentage of participants
Healing Rates Percentage of Participants Partially-Healed	2 percentage of participants	14 percentage of participants
Healing Rates Percentage of Participants Non-Healed	10 percentage of participants	11 percentage of participants

Adverse Events

Soft Tissue Trephination

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Bone Trephination

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Soft Tissue Trephination n=47 participants at risk Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Soft Tissue Trephination	Bone Trephination n=41 participants at risk Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Bone Trephination
Vascular disorders Stroke	0.00% 0/47 • Adverse event data was collected from the time the participant was enrolled up until 2-years post-operative for each participant.	2.4% 1/41 • Adverse event data was collected from the time the participant was enrolled up until 2-years post-operative for each participant.

Other adverse events

Other adverse events
Measure	Soft Tissue Trephination n=47 participants at risk Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Soft Tissue Trephination	Bone Trephination n=41 participants at risk Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired. Bone Trephination
Surgical and medical procedures Revision Surgery	4.3% 2/47 • Adverse event data was collected from the time the participant was enrolled up until 2-years post-operative for each participant.	4.9% 2/41 • Adverse event data was collected from the time the participant was enrolled up until 2-years post-operative for each participant.
Investigations Radiating Pain into Hand	0.00% 0/47 • Adverse event data was collected from the time the participant was enrolled up until 2-years post-operative for each participant.	2.4% 1/41 • Adverse event data was collected from the time the participant was enrolled up until 2-years post-operative for each participant.
Surgical and medical procedures Olecranon Fracture	0.00% 0/47 • Adverse event data was collected from the time the participant was enrolled up until 2-years post-operative for each participant.	2.4% 1/41 • Adverse event data was collected from the time the participant was enrolled up until 2-years post-operative for each participant.

Additional Information

Dr. Peter Lapner

The Ottawa Hospital Research Institute

Phone: 613-737-8899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place