ClinicalTrials.gg
CompletedNCT03407612Updated Oct 8, 2020Results posted

Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

An interventional study of Continuous Passive Motion in Femoro Acetabular Impingement, Pain, Postoperative and Hip Labral Tear, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 14 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-10-08.

Sponsored by Ohio State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 10 months after the study started (first participant enrolled Feb 2013, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
14 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 37 studies in Femoracetabular Impingement with a site in United States — 10 open to participants now, 15 under way, 1 of them phase 3. Femoracetabular Impingement · United States.

Enrollment
16th of 28
54 · median 62
Started
2013
with 3 others
No phase
18 of 37
4 open now
Registered
15th of 37
by date

Among the 37 studies in Femoracetabular Impingement with a site in United States, this one is the 16th largest by enrollment of the 28 interventional ones that give a count, is one of 4 that started in 2013, is one of 18 with no phase, and was the 15th registered.

Femoracetabular Impingement

116 studies on the registry are indexed under Femoracetabular Impingement; 37 are open to participants now.

Browse Femoracetabular Impingement studies →

Open to participants now

10 of the 37 studies in Femoracetabular Impingement with a site in United States are open now. Recruiting first, the newest first:

5 more — sign in →

All 10 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 19 Femoracetabular Impingement studies recruiting now, 6 (32%) set no upper age limit and 11 (58%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.

This study: 14 Years to 50 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 37 studies in Femoracetabular Impingement with a site in United States, or all of them as a file.
02

Study summary

The purpose of this study is to measure whether CPM (continuous passive motion) usage improves outcomes following arthroscopic hip surgery that includes labral repair. Investigators tested the hypothesis that CPM usage reduces pain levels and pain medication use and improves function in individuals who undergo hip arthroscopy.

Read the detailed description

Subjects undergoing primary hip arthroscopy for acetabular labral repair were randomized to determine whether they would receive a CPM. Those subjects receiving a CPM were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks. The total number of pain medications and average pain scores over the two weeks, as well as Hip Outcome Score Activity of Daily Living (HOS ADL) scores at standard time points were compared via a two sample t-test and intention-to-treat analysis.

03

Conditions studied

  • Femoro Acetabular Impingement
  • Pain, Postoperative
  • Hip Labral Tear

Keywords

  • continuous passive motion device
  • HOS-ADL
  • hip arthroscopy
04

Who can participate

Ages eligible
14 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • undergoing hip arthroscopy to repair a torn labrum

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • revision surgery
  • bilateral surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    CPM

    These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.

    Device: Continuous Passive Motion

  • No intervention
    No CPM

    No CPM was administered to these subjects.

Interventions

  • DeviceContinuous Passive Motion

    CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.

06

What researchers measure

Primary outcomes

  1. Change in Patient Satisfaction and Functional Outcome

    Hip Outcome Score Activities of Daily Living (HOS ADL) questionnaire completed at specific time points. Completion of the HOS ADL provides a score from 0 to 100, with a higher score corresponding to greater level of function. The improvement preoperative to 6 month postoperative scores was also computed.

    Time frame: Baseline and 6 weeks, 12 weeks, and 6 months postoperatively

Secondary outcomes

  1. Analgesic Usage

    Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications

    Time frame: Initial two postoperative weeks

  2. Pain Level

    Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.

    Time frame: Initial two postoperative weeks

07

Results

Posted Aug 2, 2018

Participant flow

Participant flow — Overall Study
MilestoneCPM UsedNo CPM Used
Started1923
Completed1923
Not completed00

Outcome measures

PrimaryChange in Patient Satisfaction and Functional Outcome

Hip Outcome Score Activities of Daily Living (HOS ADL) questionnaire completed at specific time points. Completion of the HOS ADL provides a score from 0 to 100, with a higher score corresponding to greater level of function. The improvement preoperative to 6 month postoperative scores was also computed.

Time frame:
Baseline and 6 weeks, 12 weeks, and 6 months postoperatively
Reported as:
Mean · units on a scale
Change in Patient Satisfaction and Functional Outcome
units on a scaleCPM UsedNo CPM Used
Preoperative64.5 ± 11.662.7 ± 15.0
6 weeks postoperative74.6 ± 14.872.8 ± 12.5
12 weeks postoperative81.1 ± 14.681.5 ± 11.4
6 months postoperative81.9 ± 16.482.8 ± 12.8
Improvement17.0 ± 16.020.2 ± 15.3
Statistical analysis
  • CPM Used vs No CPM Used · t-test, 2 sided · p = 0.67
  • CPM Used vs No CPM Used · t-test, 2 sided · p = 0.73
  • CPM Used vs No CPM Used · t-test, 2 sided · p = 0.87
  • CPM Used vs No CPM Used · t-test, 2 sided · p = 0.78
SecondaryAnalgesic Usage

Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications

Time frame:
Initial two postoperative weeks
Reported as:
Mean · morphine equivalent doses
Analgesic Usage
morphine equivalent dosesCPM UsedNo CPM Used
Analgesic Usage239 ± 269330 ± 227
Statistical analysis
  • CPM Used vs No CPM Used · t-test, 2 sided · p = 0.25
SecondaryPain Level

Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.

Time frame:
Initial two postoperative weeks
Reported as:
Mean · units on a scale
Pain Level
units on a scaleCPM UsedNo CPM Used
Pain Level2.94 ± 2.04.23 ± 2.0
Statistical analysis
  • CPM Used vs No CPM Used · t-test, 2 sided · p = 0.04

Adverse events

Collected over 6 months from operation date. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CPM Used—0/19 (0%)0/19 (0%)
No CPM Used—0/23 (0%)0/23 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)CPM UsedNo CPM UsedTotal
Mean36.2 ± 10.729.5 ± 11.132.5 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)CPM UsedNo CPM UsedTotal
Female182038
Male134
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)CPM UsedNo CPM UsedTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)CPM UsedNo CPM UsedTotal
United States192342
BMI
BMI(kg/m^2)CPM UsedNo CPM UsedTotal
Mean27.5 ± 7.025.1 ± 4.626.2 ± 5.8
Hand Dominance
Hand Dominance(Participants)CPM UsedNo CPM UsedTotal
Right Handed111324
Left Handed81018
08

Study locations

1 site
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43212, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2013 to primary completion in Jun 2015, 28 months.

Results were first posted in Aug 2018, 3 years 1 month after primary completion.

Of 41 non-industry interventional studies with no phase under Femoracetabular Impingement, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 79. This study's 28 months is below that.

Counting every sponsor, half of 42 studies reached it within 41 months; a quarter within 28 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2018
First posted
Jan 23, 2018
StartActual
Feb 15, 2013
Primary completionActual
Jun 25, 2015
CompletionActual
Jun 25, 2015
Results first posted
Aug 2, 2018
Last update
Oct 8, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03407612
Responsible party
John Ryan (Medical Doctor, Ohio State University) — Principal investigator
First posted
Jan 23, 2018
Start date
Feb 15, 2013
Primary completion
Jun 25, 2015
Completion
Jun 25, 2015
Results posted
Aug 2, 2018
Last update
Oct 8, 2020

Study contacts

John Ryan, MD
principal investigator · The Ohio State University Wexner Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion