Hip ArthroplastySPIGANCT07834242
Anaesthesia for Hip and Knee Arthroplasty (SPIGA)
A study testing Spinal anaesthesia and General anaesthesia in people with Hip Arthroplasty and Knee Arthroplasty, run by Zealand University Hospital.
Trial summary
Beneficial and harmful effects of spinal versus general anaesthesia in patients undergoing hip and knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthroplasty, Knee Arthroplasty, Spinal Anesthesia
- What is being tested?
- Spinal anaesthesia and General anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective primary elective hip or knee arthroplasty, including unicompartmental knee
Who cannot join
- Scheduled for elective primary hip or knee arthroplasty, including unicompartmental knee
- Age ≥ 18 years
- Unable to communicate in written and/or spoken Danish Contraindications against either spinal or general anaesthesia
About this study
Official title: Spinal Versus General Anaesthesia for Hip and Knee Arthroplasty. The Randomised, Clinical, Multicentre SPIGA Trial
Beneficial and harmful effects of spinal versus general anaesthesia in patients undergoing hip and knee arthroplasty.
Read the detailed description
Effective and safe anaesthesia is fundamental to perioperative care. Hip and knee arthroplasty are among the most frequently performed surgical procedures worldwide and are typically performed under either spinal or general anaesthesia. However, high-quality comparative evidence regarding the benefits and harms of these anaesthetic techniques remains limited and inconclusive.
Both techniques are associated with short- and long-term risks, including postoperative nausea and vomiting, hypotension, nerve injury, acute kidney injury, and respiratory and cardiovascular complications. In addition, they may differentially modulate the surgical stress response, potentially influencing postoperative recovery and risk of complications.
Objective:
To compare the benefits and harms of spinal versus general anaesthesia in patients undergoing hip or knee replacement. We hypothesise that spinal anaesthesia results in better postoperative outcomes than general anaesthesia.
Intervention:
Patients undergoing elective primary hip or knee arthroplasty will be randomised to receive either spinal or general anaesthesia, with randomisation stratified by participating centre.
Design:
The SPIGA trial is an investigator-initiated, multicentre, randomised, superiority clinical trial. Participants will be randomly allocated at a 1:1 ratio using a central, computer-generated randomisation sequence. A total sample size of 3000 participants was determined using simulation-based methods to provide at least 90% power to detect a prespecified minimally clinically important difference, corresponding to an increase of one hospital-free day in at least 10% of participants at a two-sided significance level of 0.05.
Planned sub-studies
- Short-term perioperative outcomes (0-24h postoperatively)
- Stratified analysis of anaesthetic regimens
- Impact of preoperative clinical frailty
- Conditions
- Hip Arthroplasty, Knee Arthroplasty, Spinal Anesthesia, General Anesthesia, Length of Hospital Stay, Postoperative Complications
- Being tested
- Spinal anaesthesia, General anaesthesia
- Medical subject headings
- Postoperative Complications, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anaesthesiaProcedure or surgery
Spinal anaesthesia according to local practice, including optional sedation with sedative-hypnotic pharmacological agents
General anaesthesiaProcedure or surgery
General anaesthesia according to local practice
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anaesthesia | Experimental | Not described Receives: Procedure: Spinal anaesthesia |
| General Anaesthesia | Active comparator | Not described Receives: Procedure: General anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-free days within 30 days
Defined as the number of days within the first 30 days following hip or knee arthroplasty surgery during which a participant is alive and not admitted to a hospital.
Measured: Postoperative day 0-30
Secondary outcomes (2)
Major complications
A major complication is defined as a major intra- or postoperative adverse event occurring from the initiation of anaesthesia through 30 days postoperatively.
Measured: Postoperative day 0-30
Quality of Recovery
The Quality of Recovery-15 questionnaire (QoR-15) generates a composite score ranging from 0 to 150 across five domains (physical comfort, emotional state, physical independence, psychological support, and pain), with higher scores indicating better recovery.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Mathiesen, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834242
- Sponsor's protocol ID
- EMN-2026-05830
- Acronym
- SPIGA
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be published anonymised in accordance with ICMJE (International Committee of Medical Journal Editors) guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Versus General Anaesthesia for Hip and Knee Arthroplasty. The Randomised, Clinical, Multicentre SPIGA Trial
- ClinicalTrials.gov ID
- NCT07834242
- Acronym / sponsor ID
- SPIGA / EMN-2026-05830
- Conditions
- Hip Arthroplasty, Knee Arthroplasty, Spinal Anesthesia, General Anesthesia, Length of Hospital Stay, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 22 Sep 2026 (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.
Beneficial and harmful effects of spinal versus general anaesthesia in patients undergoing hip and knee arthroplasty.
Detailed description
Effective and safe anaesthesia is fundamental to perioperative care. Hip and knee arthroplasty are among the most frequently performed surgical procedures worldwide and are typically performed under either spinal or general anaesthesia. However, high-quality comparative evidence regarding the benefits and harms of these anaesthetic techniques remains limited and inconclusive.
Both techniques are associated with short- and long-term risks, including postoperative nausea and vomiting, hypotension, nerve injury, acute kidney injury, and respiratory and cardiovascular complications. In addition, they may differentially modulate the surgical stress response, potentially influencing postoperative recovery and risk of complications.
Objective:
To compare the benefits and harms of spinal versus general anaesthesia in patients undergoing hip or knee replacement. We hypothesise that spinal anaesthesia results in better postoperative outcomes than general anaesthesia.
Intervention:
Patients undergoing elective primary hip or knee arthroplasty will be randomised to receive either spinal or general anaesthesia, with randomisation stratified by participating centre.
Design:
The SPIGA trial is an investigator-initiated, multicentre, randomised, superiority clinical trial. Participants will be randomly allocated at a 1:1 ratio using a central, computer-generated randomisation sequence. A total sample size of 3000 participants was determined using simulation-based methods to provide at least 90% power to detect a prespecified minimally clinically important difference, corresponding to an increase of one hospital-free day in at least 10% of participants at a two-sided significance level of 0.05.
Planned sub-studies
- Short-term perioperative outcomes (0-24h postoperatively)
- Stratified analysis of anaesthetic regimens
- Impact of preoperative clinical frailty
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anaesthesia | Experimental | Procedure: Spinal anaesthesia |
| General Anaesthesia | Active comparator | Procedure: General anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for elective primary elective hip or knee arthroplasty, including unicompartmental knee
Key exclusion criteria (3 listed)
- Scheduled for elective primary hip or knee arthroplasty, including unicompartmental knee
- Age ≥ 18 years
- Unable to communicate in written and/or spoken Danish Contraindications against either spinal or general anaesthesia
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 |
|---|---|---|
| Spinal anaesthesiaSpinal anaesthesia according to local practice, including optional sedation with sedative-hypnotic pharmacological agents | Procedure or surgery | Spinal Anaesthesia |
| General anaesthesiaGeneral anaesthesia according to local practice | Procedure or surgery | General Anaesthesia |
Primary outcome
Hospital-free days within 30 days
Time frame: Postoperative day 0-30
Defined as the number of days within the first 30 days following hip or knee arthroplasty surgery during which a participant is alive and not admitted to a hospital.
2 secondary outcomes
Major complications
Time frame: Postoperative day 0-30
Quality of Recovery
Time frame: 24 hours postoperatively
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 29 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be published anonymised in accordance with ICMJE (International Committee of Medical Journal Editors) guidelines.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anaesthesia and General anaesthesia in people with Hip Arthroplasty and Knee Arthroplasty, run by Zealand University Hospital.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Hospital-free days within 30 days (time frame: Postoperative day 0-30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.