Osteoarthritis (OA) of the HipNCT06838455
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
A study testing Spinopelvic mobility exercise in people with Osteoarthritis (OA) of the Hip, run by Colorado Joint Replacement at 1 site in United States.
Trial summary
The purpose of this study is to examine the extent to which spinopelvic exercises may affect either sagittal spinal deformity or spinopelvic mobility and identifying patients at risk for hip instability following a total hip replacement. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis (OA) of the Hip
- What is being tested?
- Spinopelvic mobility exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-90 scheduled for total hip arthroplasty
- Patients with primary hip osteoarthritis
- Patients with or without history of prior spinal injections
Who cannot join
- Patients undergoing revision total hip arthroplasty.
- Patients with spinal fusion.
- Patients who exercised prior to radiographic analysis.
- Patients unable to complete imaging at the designated time of day.
- Symptomatic contralateral hip osteoarthritis.
- Patients unwilling or unable to perform therapeutic exercise program as instructed. This includes patients requiring use of assistive devices or who would be deemed unsafe to perform the exercises without a 1- or 2-person assist.
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Medical Group Colorado Joint Replacement
Denver, Colorado, 80210
About this study
The purpose of this study is to examine the extent to which spinopelvic exercises may affect either sagittal spinal deformity or spinopelvic mobility and identifying patients at risk for hip instability following a total hip replacement.
- Conditions
- Osteoarthritis (OA) of the Hip
- Being tested
- Spinopelvic mobility exercise
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinopelvic mobility exerciseOther
Participants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video. The exercise regimen has been developed by the investigators of this study to incorporate exercises to increase a patient's spinopelvic mobility. Study staff that has been properly trained will be present to guide the patient through the exercise regimen and ensure the exercises are being performed accurately.
| Study group | Role | What they receive |
|---|---|---|
| Spinopelvic Exercise | Experimental | Participants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video. Receives: Other: Spinopelvic mobility exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinopelvic radiographic measurements
Spinopelvic parameter measurements on pre- and post-exercise radiographs including pelvic incidence, pelvic tilt, sacral slope and lumbar lordosis. All measurements are angles calculated in degrees.
Measured: Change from baseline to up to 1 hour after spinopelvic exercises same day.
Lumbar mobility
Calculated as the change in angle of lumbar lordosis between neutral standing and flexed-forward seated radiographs.
Measured: Change from baseline to up to 1 hour after spinopelvic exercises same day
Spinopelvic mobility
Calculated as the change in angle of pelvic tilt between neutral standing and flexed-forward seated radiographs.
Measured: Change from baseline to up to 1 hour after spinopelvic exercises same day
Patient risk classification for THA instability
Risk classification based on previously published risk factors for THA instability (lumbar stiffness, abnormal pelvic mobility, standing pelvic tilt greater than 13, sagittal spinal deformity)
Measured: Change from baseline to up to 1 hour after spinopelvic exercises same day
Secondary outcomes (7)
Oswestry Disability Index score
Patient reported outcome for pre-existing back pain and disability. The questionnaire is comprised of 10 sections, where each section is scored on a scale from 0 to 5 and summed. Higher score totals indicates worse disability.
Measured: Baseline
Hip Society Score
Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes.
Measured: Baseline
Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes.
Measured: Baseline
The Veterans Rand 12-Item Health Survey scores (VR-12)
Patient reported outcome. Scores are reported as a Z-score that is based on the United States population average of 50. Higher scores indicate better outcomes.
Measured: Baseline
Use of medication for hip/back pain
Assessed by standard of care questionnaire prior to the pre-operative visit with provider for a total hip replacement.
Measured: Baseline
Severity of hip arthritis
Graded using Kellgren-Lawrence scale for osteoarthritis on AP radiographs. Grades are between 0-4, where 0 indicates an absence of osteoarthritis and a 4 indicates severe osteoarthritis.
Measured: Baseline
Adverse events
Any adverse events sustained from therapeutic exercises
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start16 May 2025
- Primary completion1 Jul 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA) of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Joint Replacement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Jennings, Colorado Joint Replacement
- Investigators
- Dennis Douglas, MD, Principal investigator, Colorado Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838455
- Sponsor's protocol ID
- 2279537
- Status last verified
- Nov 2026
- First submitted
- 10 Feb 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dagneaux L, Marouby S, Maillot C, Canovas F, Riviere C. Dual mobility device reduces the risk of prosthetic hip instability for patients with degenerated spine: A case-control study. Orthop Traumatol Surg Res. 2019 May;105(3):461-466. doi: 10.1016/j.otsr.2018.12.003. Epub 2018 Dec 26.
PubMed 30594599Haws BE, Khechen B, Patel DV, Louie PK, Iyer S, Cardinal KL, Guntin JA, Singh K. Sagittal Imbalance Does Not Influence Cup Anteversion in Total Hip Arthroplasty Dislocations. Clin Spine Surg. 2019 Feb;32(1):E31-E36. doi: 10.1097/BSD.0000000000000712.
PubMed 30247184Buckland AJ, Abotsi EJ, Vasquez-Montes D, Ayres EW, Varlotta CG, Vigdorchik JM. Lumbar Spine Degeneration and Flatback Deformity Alter Sitting-Standing Spinopelvic Mechanics-Implications for Total Hip Arthroplasty. J Arthroplasty. 2020 Apr;35(4):1036-1041. doi: 10.1016/j.arth.2019.11.020. Epub 2019 Nov 22.
PubMed 31839349Buckland AJ, Fernandez L, Shimmin AJ, Bare JV, McMahon SJ, Vigdorchik JM. Effects of Sagittal Spinal Alignment on Postural Pelvic Mobility in Total Hip Arthroplasty Candidates. J Arthroplasty. 2019 Nov;34(11):2663-2668. doi: 10.1016/j.arth.2019.06.036. Epub 2019 Jun 22.
PubMed 31301908Lum ZC, Coury JG, Cohen JL, Dorr LD. The Current Knowledge on Spinopelvic Mobility. J Arthroplasty. 2018 Jan;33(1):291-296. doi: 10.1016/j.arth.2017.08.013. Epub 2017 Aug 24.
PubMed 28939031Murphy WS, Yun HH, Hayden B, Kowal JH, Murphy SB. The Safe Zone Range for Cup Anteversion Is Narrower Than for Inclination in THA. Clin Orthop Relat Res. 2018 Feb;476(2):325-335. doi: 10.1007/s11999.0000000000000051.
PubMed 29529664Abdel MP, von Roth P, Jennings MT, Hanssen AD, Pagnano MW. What Safe Zone? The Vast Majority of Dislocated THAs Are Within the Lewinnek Safe Zone for Acetabular Component Position. Clin Orthop Relat Res. 2016 Feb;474(2):386-91. doi: 10.1007/s11999-015-4432-5.
PubMed 26150264Esposito CI, Carroll KM, Sculco PK, Padgett DE, Jerabek SA, Mayman DJ. Total Hip Arthroplasty Patients With Fixed Spinopelvic Alignment Are at Higher Risk of Hip Dislocation. J Arthroplasty. 2018 May;33(5):1449-1454. doi: 10.1016/j.arth.2017.12.005. Epub 2017 Dec 13.
PubMed 29310920Tezuka T, Heckmann ND, Bodner RJ, Dorr LD. Functional Safe Zone Is Superior to the Lewinnek Safe Zone for Total Hip Arthroplasty: Why the Lewinnek Safe Zone Is Not Always Predictive of Stability. J Arthroplasty. 2019 Jan;34(1):3-8. doi: 10.1016/j.arth.2018.10.034. Epub 2018 Nov 2.
PubMed 30454867Ike H, Dorr LD, Trasolini N, Stefl M, McKnight B, Heckmann N. Spine-Pelvis-Hip Relationship in the Functioning of a Total Hip Replacement. J Bone Joint Surg Am. 2018 Sep 19;100(18):1606-1615. doi: 10.2106/JBJS.17.00403. No abstract available.
PubMed 30234627
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
- ClinicalTrials.gov ID
- NCT06838455
- Acronym / sponsor ID
- 2279537
- Conditions
- Osteoarthritis (OA) of the Hip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Colorado Joint ReplacementUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the extent to which spinopelvic exercises may affect either sagittal spinal deformity or spinopelvic mobility and identifying patients at risk for hip instability following a total hip replacement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinopelvic Exercise | Experimental | Other: Spinopelvic mobility exerciseParticipants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-90 scheduled for total hip arthroplasty
- Patients with primary hip osteoarthritis
- Patients with or without history of prior spinal injections
Key exclusion criteria (6 listed)
- Patients undergoing revision total hip arthroplasty.
- Patients with spinal fusion.
- Patients who exercised prior to radiographic analysis.
- Patients unable to complete imaging at the designated time of day.
- Symptomatic contralateral hip osteoarthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinopelvic mobility exerciseParticipants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video. The exercise regimen has been developed by the investigators of this study to incorporate exercises to increase a patient's spinopelvic mobility. Study staff that has been properly trained will be present to guide the patient through the exercise regimen and ensure the exercises are being performed accurately. | Other | Spinopelvic Exercise |
Primary outcome
Spinopelvic radiographic measurements
Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day.
Spinopelvic parameter measurements on pre- and post-exercise radiographs including pelvic incidence, pelvic tilt, sacral slope and lumbar lordosis. All measurements are angles calculated in degrees.
Lumbar mobility
Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day
Calculated as the change in angle of lumbar lordosis between neutral standing and flexed-forward seated radiographs.
Spinopelvic mobility
Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day
Calculated as the change in angle of pelvic tilt between neutral standing and flexed-forward seated radiographs.
Patient risk classification for THA instability
Time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day
Risk classification based on previously published risk factors for THA instability (lumbar stiffness, abnormal pelvic mobility, standing pelvic tilt greater than 13, sagittal spinal deformity)
7 secondary outcomes
Oswestry Disability Index score
Time frame: Baseline
Hip Society Score
Time frame: Baseline
Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
Time frame: Baseline
The Veterans Rand 12-Item Health Survey scores (VR-12)
Time frame: Baseline
Use of medication for hip/back pain
Time frame: Baseline
Severity of hip arthritis
Time frame: Baseline
Adverse events
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 30594599Dagneaux L, Marouby S, Maillot C, Canovas F, Riviere C. Dual mobility device reduces the risk of prosthetic hip instability for patients with degenerated spine: A case-control study. Orthop Traumatol Surg Res. 2019 May;105(3):461-466. doi: 10.1016/j.otsr.2018.12.003. Epub 2018 Dec 26.
- Background: PubMed 30247184Haws BE, Khechen B, Patel DV, Louie PK, Iyer S, Cardinal KL, Guntin JA, Singh K. Sagittal Imbalance Does Not Influence Cup Anteversion in Total Hip Arthroplasty Dislocations. Clin Spine Surg. 2019 Feb;32(1):E31-E36. doi: 10.1097/BSD.0000000000000712.
- Background: PubMed 31839349Buckland AJ, Abotsi EJ, Vasquez-Montes D, Ayres EW, Varlotta CG, Vigdorchik JM. Lumbar Spine Degeneration and Flatback Deformity Alter Sitting-Standing Spinopelvic Mechanics-Implications for Total Hip Arthroplasty. J Arthroplasty. 2020 Apr;35(4):1036-1041. doi: 10.1016/j.arth.2019.11.020. Epub 2019 Nov 22.
- Background: PubMed 31301908Buckland AJ, Fernandez L, Shimmin AJ, Bare JV, McMahon SJ, Vigdorchik JM. Effects of Sagittal Spinal Alignment on Postural Pelvic Mobility in Total Hip Arthroplasty Candidates. J Arthroplasty. 2019 Nov;34(11):2663-2668. doi: 10.1016/j.arth.2019.06.036. Epub 2019 Jun 22.
- Background: PubMed 28939031Lum ZC, Coury JG, Cohen JL, Dorr LD. The Current Knowledge on Spinopelvic Mobility. J Arthroplasty. 2018 Jan;33(1):291-296. doi: 10.1016/j.arth.2017.08.013. Epub 2017 Aug 24.
- Background: PubMed 29529664Murphy WS, Yun HH, Hayden B, Kowal JH, Murphy SB. The Safe Zone Range for Cup Anteversion Is Narrower Than for Inclination in THA. Clin Orthop Relat Res. 2018 Feb;476(2):325-335. doi: 10.1007/s11999.0000000000000051.
- Background: PubMed 26150264Abdel MP, von Roth P, Jennings MT, Hanssen AD, Pagnano MW. What Safe Zone? The Vast Majority of Dislocated THAs Are Within the Lewinnek Safe Zone for Acetabular Component Position. Clin Orthop Relat Res. 2016 Feb;474(2):386-91. doi: 10.1007/s11999-015-4432-5.
- Background: PubMed 29310920Esposito CI, Carroll KM, Sculco PK, Padgett DE, Jerabek SA, Mayman DJ. Total Hip Arthroplasty Patients With Fixed Spinopelvic Alignment Are at Higher Risk of Hip Dislocation. J Arthroplasty. 2018 May;33(5):1449-1454. doi: 10.1016/j.arth.2017.12.005. Epub 2017 Dec 13.
- Background: PubMed 30454867Tezuka T, Heckmann ND, Bodner RJ, Dorr LD. Functional Safe Zone Is Superior to the Lewinnek Safe Zone for Total Hip Arthroplasty: Why the Lewinnek Safe Zone Is Not Always Predictive of Stability. J Arthroplasty. 2019 Jan;34(1):3-8. doi: 10.1016/j.arth.2018.10.034. Epub 2018 Nov 2.
- Background: PubMed 30234627Ike H, Dorr LD, Trasolini N, Stefl M, McKnight B, Heckmann N. Spine-Pelvis-Hip Relationship in the Functioning of a Total Hip Replacement. J Bone Joint Surg Am. 2018 Sep 19;100(18):1606-1615. doi: 10.2106/JBJS.17.00403. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Douglas, MD principal investigator
Colorado Joint Replacement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinopelvic mobility exercise in people with Osteoarthritis (OA) of the Hip, run by Colorado Joint Replacement at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinopelvic radiographic measurements (time frame: Change from baseline to up to 1 hour after spinopelvic exercises same day.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06838455, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.