Trial Outcomes & Findings for Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction (NCT NCT00529958)

Last Updated: 2024-12-11

Results Overview

The 32-item patient-reported Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) questionnaire assesses symptoms/physical complaints, work-related, sports/recreational, lifestyle and social/emotional concerns. A higher score on the 0 to 100mm visual analog scale represents better quality of life.

Recruitment status

COMPLETED

Study phase

Target enrollment

330 participants

Primary outcome timeframe

Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively

Results posted on

2024-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Patellar Tendon (PT) ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
2-Year Follow-up STARTED	110	110	110
2-Year Follow-up COMPLETED	106	108	108
2-Year Follow-up NOT COMPLETED	4	2	2
5-Year Follow-up STARTED	106	108	108
5-Year Follow-up COMPLETED	103	105	107
5-Year Follow-up NOT COMPLETED	3	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Patellar Tendon (PT) ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
2-Year Follow-up Lost to Follow-up	1	2	2
2-Year Follow-up Withdrawal by Subject	3	0	0
5-Year Follow-up Lost to Follow-up	2	3	1
5-Year Follow-up Withdrawal by Subject	1	0	0

Baseline Characteristics

Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Total n=330 Participants Total of all reporting groups
Age, Continuous	28.7 years STANDARD_DEVIATION 9.7 • n=93 Participants	28.5 years STANDARD_DEVIATION 9.9 • n=4 Participants	28.3 years STANDARD_DEVIATION 9.8 • n=27 Participants	28.5 years STANDARD_DEVIATION 9.8 • n=483 Participants
Sex: Female, Male Female	47 Participants n=93 Participants	51 Participants n=4 Participants	49 Participants n=27 Participants	147 Participants n=483 Participants
Sex: Female, Male Male	63 Participants n=93 Participants	59 Participants n=4 Participants	61 Participants n=27 Participants	183 Participants n=483 Participants
Chronicity: Acute, Chronic Acute	16 Participants n=93 Participants	16 Participants n=4 Participants	17 Participants n=27 Participants	49 Participants n=483 Participants
Chronicity: Acute, Chronic Chronic	94 Participants n=93 Participants	94 Participants n=4 Participants	93 Participants n=27 Participants	281 Participants n=483 Participants
Injured side: Left, Right Left	54 Participants n=93 Participants	63 Participants n=4 Participants	54 Participants n=27 Participants	171 Participants n=483 Participants
Injured side: Left, Right Right	56 Participants n=93 Participants	47 Participants n=4 Participants	56 Participants n=27 Participants	159 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively

Population: There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome 6 Months	61.7 Score (0 to 100) Standard Deviation 19.1	65.2 Score (0 to 100) Standard Deviation 18.4	65.5 Score (0 to 100) Standard Deviation 17.9
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome 1-Year	74.5 Score (0 to 100) Standard Deviation 18.7	75.4 Score (0 to 100) Standard Deviation 18.5	73.6 Score (0 to 100) Standard Deviation 19.2
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome 2-Years	84.6 Score (0 to 100) Standard Deviation 16.6	82.5 Score (0 to 100) Standard Deviation 17.7	82.4 Score (0 to 100) Standard Deviation 17.5
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome Baseline	27.0 Score (0 to 100) Standard Deviation 13.1	29.8 Score (0 to 100) Standard Deviation 14.7	28.7 Score (0 to 100) Standard Deviation 13.7
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome 3 Months	47.7 Score (0 to 100) Standard Deviation 17.2	52.6 Score (0 to 100) Standard Deviation 19.2	50.5 Score (0 to 100) Standard Deviation 16.9
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome 5-Years	82.5 Score (0 to 100) Standard Deviation 17.9	83.9 Score (0 to 100) Standard Deviation 18.2	81.1 Score (0 to 100) Standard Deviation 19.3

SECONDARY outcome

Timeframe: Minimum 2-year Follow-up, 5-Year Follow-up, 10-Year Follow-up

Population: There were 110 participants randomized to each study group. At 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

* COMPLETE TRAUMATIC RE-RUPTURE - defined as a consequence of an acute traumatic event resulting in a change in static stability since the most recent follow-up visit; determined clinically by a definite loss of end point on Lachman testing, increased anterior translation (\>3mm) and a greater than or equal grade 2 pivot shift. Confirmed by MRI or diagnostic arthroscopy. * PARTIAL TRAUMATIC TEARS - defined as a consequence of an acute traumatic event resulting in a suspected meniscal injury or graft tear on history, without the clinical characteristics of a "complete traumatic rerupture". Confirmed by MR or diagnostic arthroscopy. * TRAUMATIC RE-INJURY - combined total of "complete traumatic re-ruptures" and "partial traumatic tears". * ATRAUMATIC GRAFT FAILURES - defined in the absence of an acute traumatic event, with greater than or equal grade 2 pivot shift and/or greater than or equal to 6mm side-to-side difference on the KT arthrometer.

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures Minimum 2-Year Follow-up · No re-injury or failure	91 Participants	81 Participants	79 Participants
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures Minimum 2-Year Follow-up · Complete Traumatic Re-rupture	3 Participants	7 Participants	7 Participants
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures Minimum 2-Year Follow-up · Partial Traumatic Tear	0 Participants	5 Participants	4 Participants
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures Minimum 2-Year Follow-up · Atraumatic Graft Failure	16 Participants	17 Participants	20 Participants
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures 5-Year Follow-up · No re-injury or failure	92 Participants	80 Participants	76 Participants
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures 5-Year Follow-up · Complete Traumatic Re-rupture	4 Participants	11 Participants	11 Participants
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures 5-Year Follow-up · Partial Traumatic Tear	0 Participants	5 Participants	6 Participants
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures 5-Year Follow-up · Atraumatic Graft Failure	7 Participants	9 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline, 1, 2, 5 years post-operatively

Population: There were 110 participants randomized to each study group. At 1-, 2-, and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

IKDC Objective group grades: Normal (A), Nearly Normal (B), Abnormal (C), Severely Abnormal (D) The IKDC Objective Overall Group Grade is determined by the lowest grade assigned to defined objective knee examination measurements, including effusion, passive motion deficit and manual/instrumented ligament examinations (i.e. Lachman, anterior-posterior (AP) translation).

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 5-Years · Abnormal (C)	13 Participants	18 Participants	24 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 5-Years · Severely Abnormal (D)	0 Participants	0 Participants	2 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade Baseline · Normal (A)	0 Participants	0 Participants	0 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade Baseline · Nearly Normal (B)	1 Participants	4 Participants	5 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade Baseline · Abnormal (C)	103 Participants	101 Participants	100 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade Baseline · Severely Abnormal (D)	5 Participants	4 Participants	5 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 1-Year · Normal (A)	9 Participants	9 Participants	9 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 1-Year · Nearly Normal (B)	79 Participants	77 Participants	71 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 1-Year · Abnormal (C)	13 Participants	18 Participants	19 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 1-Year · Severely Abnormal (D)	0 Participants	0 Participants	2 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 2-Years · Normal (A)	12 Participants	12 Participants	19 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 2-Years · Nearly Normal (B)	65 Participants	62 Participants	56 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 2-Years · Abnormal (C)	23 Participants	28 Participants	30 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 2-Years · Severely Abnormal (D)	1 Participants	2 Participants	2 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 5-Years · Normal (A)	24 Participants	18 Participants	19 Participants
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade 5-Years · Nearly Normal (B)	61 Participants	63 Participants	58 Participants

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively

Population: There were 110 participants randomized to each study group. At 1-, 2- and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Mean International Knee Documentation Committee (IKDC) Subjective Score Baseline	50.1 score on a scale (out of 100) Standard Deviation 13.9	51.0 score on a scale (out of 100) Standard Deviation 16.2	51.5 score on a scale (out of 100) Standard Deviation 14.6
Mean International Knee Documentation Committee (IKDC) Subjective Score 3 Months	60.2 score on a scale (out of 100) Standard Deviation 12.2	65.7 score on a scale (out of 100) Standard Deviation 14.2	63.1 score on a scale (out of 100) Standard Deviation 12.1
Mean International Knee Documentation Committee (IKDC) Subjective Score 6 Months	71.1 score on a scale (out of 100) Standard Deviation 11.1	76.1 score on a scale (out of 100) Standard Deviation 13.1	75.8 score on a scale (out of 100) Standard Deviation 11.1
Mean International Knee Documentation Committee (IKDC) Subjective Score 1-Year	79.7 score on a scale (out of 100) Standard Deviation 11.7	81.7 score on a scale (out of 100) Standard Deviation 12.6	80.0 score on a scale (out of 100) Standard Deviation 11.9
Mean International Knee Documentation Committee (IKDC) Subjective Score 2-Years	84.6 score on a scale (out of 100) Standard Deviation 13.8	85.3 score on a scale (out of 100) Standard Deviation 11.6	84.2 score on a scale (out of 100) Standard Deviation 11.8
Mean International Knee Documentation Committee (IKDC) Subjective Score 5-Years	83.9 score on a scale (out of 100) Standard Deviation 12.9	85.2 score on a scale (out of 100) Standard Deviation 13.0	84.3 score on a scale (out of 100) Standard Deviation 13.4

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively

The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee. Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament.

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Number of Participants With Each Pivot Shift Grade Baseline · Equal	0 Participants	1 Participants	0 Participants
Number of Participants With Each Pivot Shift Grade Baseline · Glide (+)	6 Participants	6 Participants	9 Participants
Number of Participants With Each Pivot Shift Grade Baseline · Clunk (++)	103 Participants	102 Participants	99 Participants
Number of Participants With Each Pivot Shift Grade Baseline · Gross (+++)	1 Participants	1 Participants	2 Participants
Number of Participants With Each Pivot Shift Grade 3 Months · Equal	73 Participants	60 Participants	80 Participants
Number of Participants With Each Pivot Shift Grade 3 Months · Glide (+)	30 Participants	45 Participants	25 Participants
Number of Participants With Each Pivot Shift Grade 3 Months · Clunk (++)	1 Participants	1 Participants	2 Participants
Number of Participants With Each Pivot Shift Grade 3 Months · Gross (+++)	0 Participants	0 Participants	0 Participants
Number of Participants With Each Pivot Shift Grade 6 Months · Equal	62 Participants	53 Participants	66 Participants
Number of Participants With Each Pivot Shift Grade 6 Months · Glide (+)	38 Participants	45 Participants	39 Participants
Number of Participants With Each Pivot Shift Grade 6 Months · Clunk (++)	3 Participants	5 Participants	2 Participants
Number of Participants With Each Pivot Shift Grade 6 Months · Gross (+++)	0 Participants	0 Participants	0 Participants
Number of Participants With Each Pivot Shift Grade 1-Year · Equal	47 Participants	46 Participants	53 Participants
Number of Participants With Each Pivot Shift Grade 1-Year · Glide (+)	51 Participants	48 Participants	41 Participants
Number of Participants With Each Pivot Shift Grade 1-Year · Clunk (++)	3 Participants	12 Participants	7 Participants
Number of Participants With Each Pivot Shift Grade 1-Year · Gross (+++)	0 Participants	0 Participants	1 Participants
Number of Participants With Each Pivot Shift Grade 2-Years · Equal	36 Participants	28 Participants	38 Participants
Number of Participants With Each Pivot Shift Grade 2-Years · Glide (+)	52 Participants	57 Participants	49 Participants
Number of Participants With Each Pivot Shift Grade 2-Years · Clunk (++)	14 Participants	18 Participants	19 Participants
Number of Participants With Each Pivot Shift Grade 2-Years · Gross (+++)	0 Participants	1 Participants	1 Participants
Number of Participants With Each Pivot Shift Grade 5-Years · Equal	37 Participants	29 Participants	30 Participants
Number of Participants With Each Pivot Shift Grade 5-Years · Glide (+)	50 Participants	54 Participants	50 Participants
Number of Participants With Each Pivot Shift Grade 5-Years · Clunk (++)	12 Participants	16 Participants	22 Participants
Number of Participants With Each Pivot Shift Grade 5-Years · Gross (+++)	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, 2 and 5 years post-operatively

Population: At 2 and 5-year follow-up, outcome data was not collected on all participants due to loss-to-follow-up, withdrawal or missed study visits.

Patients kneeled down on the same hard surface (i.e. clinic floor) and self-reported the pain on a scale of: none, mild, moderate or severe. The number of patients reporting moderate or severe kneeling pain were combined in the reported proportions.

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Proportion of Patients With Moderate or Severe Kneeling Pain Baseline	29 Participants	29 Participants	18 Participants
Proportion of Patients With Moderate or Severe Kneeling Pain 2 Years	17 Participants	9 Participants	4 Participants
Proportion of Patients With Moderate or Severe Kneeling Pain 5 Years	10 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, 1 and 2 years post-operatively

Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity.

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Knee Laxity as Measured by the KT Arthrometer Baseline	4.9 Millimetres (side-to-side difference) Standard Deviation 2.3	5.0 Millimetres (side-to-side difference) Standard Deviation 2.1	5.1 Millimetres (side-to-side difference) Standard Deviation 2.3
Knee Laxity as Measured by the KT Arthrometer 1-Year	1.9 Millimetres (side-to-side difference) Standard Deviation 2.3	2.8 Millimetres (side-to-side difference) Standard Deviation 1.8	2.8 Millimetres (side-to-side difference) Standard Deviation 2.2
Knee Laxity as Measured by the KT Arthrometer 2-Years	1.9 Millimetres (side-to-side difference) Standard Deviation 2.5	3.0 Millimetres (side-to-side difference) Standard Deviation 2.1	2.7 Millimetres (side-to-side difference) Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline, 6 months, 1 and 2 years post-operatively

Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Mean Tegner Activity Level Baseline	7.7 Activity Level Standard Deviation 1.7	7.9 Activity Level Standard Deviation 1.7	7.9 Activity Level Standard Deviation 1.6
Mean Tegner Activity Level 6 Months	4.7 Activity Level Standard Deviation 1.6	4.8 Activity Level Standard Deviation 1.6	5.0 Activity Level Standard Deviation 1.7
Mean Tegner Activity Level 1 Year	6.0 Activity Level Standard Deviation 1.8	6.1 Activity Level Standard Deviation 1.9	5.9 Activity Level Standard Deviation 2.0
Mean Tegner Activity Level 2 Years	6.5 Activity Level Standard Deviation 1.8	6.4 Activity Level Standard Deviation 2.0	6.4 Activity Level Standard Deviation 1.9

SECONDARY outcome

Timeframe: 1, 2 and 5 years post-operatively

Proportion of patients returning to pre-injury levels, as measured by the Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)).

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Return to Pre-injury Tegner Activity Level 1 Year	27 Participants	33 Participants	28 Participants
Return to Pre-injury Tegner Activity Level 2 Years	44 Participants	43 Participants	36 Participants
Return to Pre-injury Tegner Activity Level 5 Years	35 Participants	41 Participants	41 Participants

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively

The Cincinnati Occupational Rating Scale assesses the level of work-related activities, including sitting, standing, walking, squatting, climbing, lifting and carrying weighted objects. The score ranges from 0 to 100, with a lower score representing more sedentary work-related activities.

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Cincinnati Occupational Rating Scale Baseline	36.6 score on a scale (out of 100) Standard Deviation 19.9	35.4 score on a scale (out of 100) Standard Deviation 21.3	36.3 score on a scale (out of 100) Standard Deviation 17.7
Cincinnati Occupational Rating Scale 3 Months	34.7 score on a scale (out of 100) Standard Deviation 17.2	36.1 score on a scale (out of 100) Standard Deviation 22.1	36.4 score on a scale (out of 100) Standard Deviation 19.3
Cincinnati Occupational Rating Scale 6 Months	35.7 score on a scale (out of 100) Standard Deviation 18.3	37.4 score on a scale (out of 100) Standard Deviation 21.6	37.0 score on a scale (out of 100) Standard Deviation 20.2
Cincinnati Occupational Rating Scale 1 Year	36.7 score on a scale (out of 100) Standard Deviation 17.2	38.0 score on a scale (out of 100) Standard Deviation 22.0	38.0 score on a scale (out of 100) Standard Deviation 21.5
Cincinnati Occupational Rating Scale 2 Years	36.8 score on a scale (out of 100) Standard Deviation 19.4	34.4 score on a scale (out of 100) Standard Deviation 22.1	38.0 score on a scale (out of 100) Standard Deviation 22.5
Cincinnati Occupational Rating Scale 5 Years	35.9 score on a scale (out of 100) Standard Deviation 18.4	36.6 score on a scale (out of 100) Standard Deviation 23.8	37.8 score on a scale (out of 100) Standard Deviation 24.2

SECONDARY outcome

Timeframe: During surgery

Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Skin-to-Skin Operative Times	75.3 Minutes Standard Deviation 14.7	67.8 Minutes Standard Deviation 14.6	88.0 Minutes Standard Deviation 14.9

SECONDARY outcome

Timeframe: Baseline, 2 and 5 years post-operatively

The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years post-operatively

All complications/adverse events that occurred within the first two-years post-operatively. See Adverse Events section for results of this outcome.

Outcome measures

Outcome measures
Measure	Patellar Tendon (PT) n=110 Participants ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 Participants ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 Participants ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Deep wound infection	1 Participants	0 Participants	0 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Superficial wound infection	0 Participants	2 Participants	2 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Chondral lesion	1 Participants	0 Participants	1 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Failed meniscal repair	2 Participants	6 Participants	4 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Stiffness	4 Participants	2 Participants	3 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Hamstring injury	1 Participants	6 Participants	12 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Tibial periostitis	1 Participants	2 Participants	4 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Stitch abscess	2 Participants	1 Participants	0 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Cellulitis	0 Participants	0 Participants	3 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Meniscal cyst	1 Participants	0 Participants	0 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Patellar tendinopathy	1 Participants	0 Participants	0 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Persistent effusion / inflammation	1 Participants	2 Participants	5 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Sensory nerve problems	4 Participants	1 Participants	3 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Wound dehiscence	1 Participants	0 Participants	1 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Hardware issues	0 Participants	0 Participants	0 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Massive pulmonary embolism	0 Participants	0 Participants	1 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Deep vein thrombosis	0 Participants	0 Participants	1 Participants
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) Septic arthritis	0 Participants	1 Participants	0 Participants

Adverse Events

Patellar Tendon (PT)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Hamstring (HT)

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Double-Bundle (DB)

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patellar Tendon (PT) n=110 participants at risk ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	Hamstring (HT) n=110 participants at risk ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Double-Bundle (DB) n=110 participants at risk ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Infections and infestations Septic Arthritis	0.00% 0/110 • Two years post-operatively. Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.	0.91% 1/110 • Two years post-operatively. Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.	0.00% 0/110 • Two years post-operatively. Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.
Blood and lymphatic system disorders Massive Pulmonary Embolism	0.00% 0/110 • Two years post-operatively. Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.	0.00% 0/110 • Two years post-operatively. Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.	0.91% 1/110 • Two years post-operatively. Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.
Blood and lymphatic system disorders Deep Vein Thrombosis	0.00% 0/110 • Two years post-operatively. Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.	0.00% 0/110 • Two years post-operatively. Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.	0.91% 1/110 • Two years post-operatively. Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.

Other adverse events

Additional Information

ACL RCT Research Coordinator

University of Calgary Sport Medicine Centre

Phone: 403-220-8944

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place