Trial Outcomes & Findings for The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction (NCT NCT05529511)
NCT ID: NCT05529511
Last Updated: 2025-04-15
Results Overview
Understanding of patients' lived experiences of the treatment pathway following a diagnosis of an ACL rupture and agreed surgical management. Qualitative data collected from individual semi-structured interviews.
Recruitment status
COMPLETED
Target enrollment
26 participants
Primary outcome timeframe
Interviews completed within approximately 60 minutes
Results posted on
2025-04-15
Participant Flow
Participant milestones
| Measure |
Phase 1 - Preoperative
Interviews were completed with 18 participants who were at one of three time points on the patient pathway:
1. Pre-anterior cruciate ligament surgery
2. 3-month after anterior cruciate ligament surgery
3. 12-months anterior cruciate ligament surgery
Phase 1 - semi-structured interviews: Semi-structured face-to-face or virtual interviews.
|
Phase 2 - Nominal Group Technique Panel
Consensus meetings were completed with 8 participants (clinicians, patients and stakeholders) to develop the intervention.
Phase 2 - 2 online consensus meeting
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
8
|
|
Overall Study
COMPLETED
|
18
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction
Baseline characteristics by cohort
| Measure |
Phase 1 - Preoperative
n=18 Participants
Interviews were completed with 18 participants who were at one of three time points on the patient pathway:
1. Pre-anterior cruciate ligament surgery
2. 3-month after anterior cruciate ligament surgery
3. 12-months anterior cruciate ligament surgery
Phase 1 - semi-structured interviews: Semi-structured face-to-face or virtual interviews.
|
Phase 2 - Nominal Group Technique Panel
n=8 Participants
Consensus meetings were completed with 8 participants (clinicians, patients and stakeholders) to develop the intervention.
Phase 2 - 2 online consensus meeting
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
NA years
n=7 Participants
|
NA years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
2 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
British Asian
|
1 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pakistani
|
1 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Time-point on the pathway
Preoperative
|
10 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Time-point on the pathway
3-months post-operative
|
6 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Time-point on the pathway
12-months postoperative
|
2 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Interviews completed within approximately 60 minutesPopulation: All participants remained in the study.
Understanding of patients' lived experiences of the treatment pathway following a diagnosis of an ACL rupture and agreed surgical management. Qualitative data collected from individual semi-structured interviews.
Outcome measures
| Measure |
Phase 1 - Preoperative
n=18 Participants
Interviews were completed with 18 participants who were at one of three time points on the patient pathway:
1. Pre-anterior cruciate ligament surgery
2. 3-month after anterior cruciate ligament surgery
3. 12-months anterior cruciate ligament surgery
Phase 1 - semi-structured interviews: Semi-structured face-to-face or virtual interviews.
|
Phase 2 - Nominal Group Technique Panel
Consensus meetings were completed with 8 participants (clinicians, patients and stakeholders) to develop the intervention.
Phase 2 - 2 online consensus meeting
|
|---|---|---|
|
Number of Participants Who Completed Semi-structured Interviews
Explore patient experiences of preoperative treatment
|
18 Participants
|
0 Participants
|
|
Number of Participants Who Completed Semi-structured Interviews
Explore patient experiences of postoperative treatment
|
8 Participants
|
—
|
|
Number of Participants Who Completed Semi-structured Interviews
Explore views and involvement in prehabilitation
|
12 Participants
|
—
|
|
Number of Participants Who Completed Semi-structured Interviews
Explore sources and consistency of healthcare advice
|
18 Participants
|
—
|
PRIMARY outcome
Timeframe: Two online meetings completed, up to 2 hours on 2 days approximately 1-month apart.Population: All participant data analysed.
Intervention developed with clinicians, patients and stakeholders for use with patients awaiting anterior cruciate ligament reconstruction in the National Health Service (NHS). Consensus was determined through voting set at an 70% threshold.
Outcome measures
| Measure |
Phase 1 - Preoperative
Interviews were completed with 18 participants who were at one of three time points on the patient pathway:
1. Pre-anterior cruciate ligament surgery
2. 3-month after anterior cruciate ligament surgery
3. 12-months anterior cruciate ligament surgery
Phase 1 - semi-structured interviews: Semi-structured face-to-face or virtual interviews.
|
Phase 2 - Nominal Group Technique Panel
n=8 Participants
Consensus meetings were completed with 8 participants (clinicians, patients and stakeholders) to develop the intervention.
Phase 2 - 2 online consensus meeting
|
|---|---|---|
|
Number of Participants in the Nominal Group Technique Panel
Clinician participants
|
0 Participants
|
5 Participants
|
|
Number of Participants in the Nominal Group Technique Panel
Therapy manager participant
|
0 Participants
|
1 Participants
|
|
Number of Participants in the Nominal Group Technique Panel
Patient participants
|
0 Participants
|
2 Participants
|
Adverse Events
Phase 1 - Preoperative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 - Nominal Group Technique Panel
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
Hayley Carter
University Hospitals of Derby and Burton NHS Foundation Trust
Phone: 01332254631
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place